A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)

A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease

The purpose of this study was to assess the safety and tolerability of ABBV-951 (Foslevodopa/Foscarbidopa) in participants with Parkinson's disease (PD).

This was a single-arm study with preplanned analyses conducted by dose subgroup (Low Dose or High Dose) based on the modal total daily dose (most frequent dose) over the treatment period.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease (PD)
• Intervention / Treatment: Drug: ABBV-951

• Study Type: Interventional
• Enrollment (Actual): 244
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital /ID# 207628
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital /ID# 207633
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital /ID# 207634
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Alfred Health /ID# 207632
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Perron Institute /ID# 207627
• Belgium
  • Brugge, Belgium, 8000
    • AZ Sint-Jan Brugge /ID# 208178
  • Liege, Belgium, 4000
    • Groupe Sante CHC - Clinique du MontLegia /ID# 208177
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Universitair Ziekenhuis Leuven /ID# 209058
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • University of Calgary - Movement Disorders Clinic /ID# 207342
  • Quebec
    • Quebec City, Quebec, Canada, G1W 4R4
      • Centre de Recherche St-Louis /ID# 207344
• Denmark
  • Hovedstaden
    • Copenhagen NV, Hovedstaden, Denmark, 2400
      • Bispebjerg and Frederiksberg Hospital /ID# 207669
  • Midtjylland
    • Aarhus N, Midtjylland, Denmark, 8200
      • Aarhus University Hospital /ID# 207668
  • Syddanmark
    • Odense C, Syddanmark, Denmark, 5000
      • Odense University Hospital /ID# 207871
• Germany
  • Beelitz-Heilstaetten, Germany, 14547
    • Kliniken Beelitz GmbH /ID# 208600
  • Haag, Germany, 83527
    • InnKlinikum Haag /ID# 208601
  • Baden-Wuerttemberg
    • Ulm, Baden-Wuerttemberg, Germany, 89081
      • Universitaetsklinikum Ulm /ID# 208602
• Italy
  • Messina, Italy, 98124
    • IRCCS Centro Neurolesi Bonino Pulejo /ID# 207975
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 207955
  • Padova, Italy, 35128
    • Azienda Ospedaliera di Padova /ID# 208077
• Japan
  • Hokkaido
    • Asahikawa-shi, Hokkaido, Japan, 070-8644
      • National Hospital Organization Asahikawa Medical Center /ID# 210914
  • Kyoto
    • Kyoto-shi, Kyoto, Japan, 616-8255
      • National Hospital Organization Utano National Hospital /ID# 210912
  • Osaka
    • Suita-shi, Osaka, Japan, 565-0871
      • Osaka University Hospital /ID# 210913
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital /ID# 210915
    • Kodaira-shi, Tokyo, Japan, 187-8551
      • National Center of Neurology and Psychiatry /ID# 210911
• Netherlands
  • Nieuwegein, Netherlands, 3435 CM
    • St. Antonius Ziekenhuis /ID# 208529
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
      • Erasmus Medisch Centrum /ID# 208168
• Russian Federation
  • Sankt-Peterburg
    • Sestroretsk, Sankt-Peterburg, Russian Federation, 197706
      • City Clinical Hospital #40 /ID# 216301
    • St. Petersburg, Sankt-Peterburg, Russian Federation, 197101
      • Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 216303
• Spain
  • A Coruna, Spain, 15006
    • Hospital Universitario A Coruna - CHUAC /ID# 212147
  • Barcelona, Spain, 08041
    • Hospital Santa Creu i Sant Pau /ID# 208240
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de las Nieves /ID# 208242
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal /ID# 208241
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio /ID# 208239
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Hospital General Universitario de Elche /ID# 209777
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitario de Bellvitge /ID# 209539
• Sweden
  • Skane Lan
    • Lund, Skane Lan, Sweden, SE 221 41
      • Skane University Hospital Lund /ID# 207811
  • Stockholms Lan
    • Stockholm, Stockholms Lan, Sweden, 113 65
      • Centrum for neurologi /ID# 207716
  • Vastra Gotalands Lan
    • Gothenburg, Vastra Gotalands Lan, Sweden, 413 46
      • Sahlgrenska University Hospital /ID# 207718
• United Kingdom
  • London, United Kingdom, SE5 9RS
    • King's College Hospital NHS Foundation Trust /ID# 208413
  • Plymouth, United Kingdom, PL6 5FP
    • University Hospital Plymouth NHS Trust /ID# 208447
  • Scotland
    • Dundee, Scotland, United Kingdom, DD2 1UB
      • NHS Tayside /ID# 209242
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham - Main /ID# 207996
  • Arizona
    • Sun City, Arizona, United States, 85351
      • Banner Sun Health Res Inst /ID# 208811
  • California
    • Fountain Valley, California, United States, 92708
      • The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 216126
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital /ID# 207968
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 207677
  • Illinois
    • Chicago, Illinois, United States, 60611-2927
      • Northwestern University Feinberg School of Medicine /ID# 208812
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana Clinical Research Cent /ID# 207952
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Univ Kansas Med Ctr /ID# 208963
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Chandler Medical Center /ID# 207603
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital /ID# 207993
  • Minnesota
    • Saint Paul, Minnesota, United States, 55130-2400
      • Health Partners /ID# 207950
  • Missouri
    • Columbia, Missouri, United States, 65203
      • University of Missouri /ID# 209043
    • Saint Louis, Missouri, United States, 63110
      • Washington University-School of Medicine /ID# 207525
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center /ID# 207972
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 209784
  • Oregon
    • Portland, Oregon, United States, 97232-2003
      • Legacy Medical Group - Neurology /ID# 208031
  • South Carolina
    • Greenville, South Carolina, United States, 29605-4255
      • Prisma Health Cancer Institute-Faris Road /ID# 207650
  • Texas
    • Dallas, Texas, United States, 75243-1188
      • Neurology Consultants of Dallas - LBJ Fwy /ID# 207619
    • Houston, Texas, United States, 77030-4202
      • Baylor College of Medicine /ID# 207620
    • Round Rock, Texas, United States, 78681
      • Central Texas Neurology Consul /ID# 216918
    • San Antonio, Texas, United States, 78229-3901
      • Univ Texas HSC San Antonio /ID# 208958
  • Washington
    • Kirkland, Washington, United States, 98034-3029
      • Booth Gardner Parkinson's Care Center /ID# 208026
    • Spokane, Washington, United States, 99202-1342
      • Inland Northwest Research /ID# 208122
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226-3522
      • Medical College of Wisconsin /ID# 207999

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants with diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa-responsive
• Participants must be judged by the investigator to be inadequately controlled by current therapy, have recognizable/identifiable "Off" and "On" states (motor fluctuations), and have a minimum of 2.5 hours of "Off" time per day

Exclusion Criteria:

• Participant is cognitively impaired and is not able to safely and effectively manage the drug delivery system and the diaries and is not able to adhere to the study
• Participant is considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABBV-951 Low Dose Subgroup; After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.	Drug: ABBV-951; Solution for continuous subcutaneous infusion (CSCI); Other Names: Foslevodopa/Foscarbidopa
Experimental: ABBV-951 High Dose Subgroup; After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.	Drug: ABBV-951; Solution for continuous subcutaneous infusion (CSCI); Other Names: Foslevodopa/Foscarbidopa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.	From first dose of study drug until 30 days following last dose of study drug (up to 480 days)
Number of Participants With Adverse Events of Special Interest	Treatment emergent adverse events of special interest are defined as any adverse event of infusion site infections, infusion site reactions, hallucinations/psychosis, falls and associated injuries, polyneuropathy (peripheral neuropathy), weight loss, or somnolence from the first dose of study drug until 30 days following last dose of study drug.	From first dose of study drug until 30 days following last dose of study drug (up to 480 days)
Number of Participants With Numeric Grade Equal to or Higher Than 5 and With Letter Grade Equal to or Higher Than D on the Infusion Site Evaluation Scale	Skin tolerability was assessed using the Infusion Site Evaluation Scale, a 2-part numeric (0-7) and letter (A-G) grade scale, where a notable skin reaction is defined as a reaction with a numeric grade of 6 or 7 or a letter grade of D, E, F, or G. Any observation of infusion site reaction with irritation criteria > 2 or > C was recorded as an adverse event (AE).	Day 1, Day 2, Week 1, Week 2, Week 3, Week 4, Week 6, Week 13, Week 26, Week 39, and Week 52
Hematocrit (Hematology): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Hemoglobin (Hematology): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Neutrophils (Hematology): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Lymphocytes (Hematology): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Monocytes (Hematology): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Absolute Platelet Count (Hematology): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Creatinine (Clinical Chemistry): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Sodium (Clinical Chemistry): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Potassium (Clinical Chemistry): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Calcium (Clinical Chemistry): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Uric Acid (Clinical Chemistry): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Albumin (Clinical Chemistry): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Glucose (Clinical Chemistry): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Magnesium (Clinical Chemistry): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Homocysteine (Clinical Chemistry): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, and 52
Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, and 52
Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, and 52
pH (Urinalysis): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Specific Gravity (Urinalysis): Change From Baseline to End of Study	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.	Baseline, Weeks 6, 26, 39, and 52
Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study	Orthostatic blood pressure was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.	Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)
Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study	Orthostatic blood pressure was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.	Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)
Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study	Orthostatic pulse rate was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.	Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)
Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study	12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.	Baseline, Day 1 (postdose), Weeks 6 and 52
Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study	12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.	Baseline, Day 1 (postdose), Weeks 6 and 52
Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study	12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.	Baseline, Day 1 (postdose), Weeks 6 and 52
Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study	12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.	Baseline, Day 1 (postdose), Weeks 6 and 52
Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study	12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.	Baseline, Day 1 (postdose), Weeks 6 and 52
Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study	12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.	Baseline, Day 1 (postdose), Weeks 6 and 52
Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study	12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.	Baseline, Day 1 (postdose), Weeks 6 and 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Daily Normalized "Off" Time: Change From Baseline to End of Study	Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. "Off" time is defined as periods of poor mobility, tremor, slowness, and stiffness. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. When "Off" was the first morning symptom upon awakening, this was considered morning akinesia in this study. Baseline value is defined as the average of normalized "Off" time collected over the 2 PD Diary days before the Enrollment visit. Negative changes from Baseline indicate improvement.	Baseline, Weeks 1, 6, 13, 26, 39, and 52
Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline to End of Study	Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. "On" time is defined as periods of good motor symptom control. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. Baseline value is defined as the average of normalized "On" time with troublesome dyskinesia collected over the 2 PD Diary days before the Enrollment visit. Negative changes from Baseline indicate improvement.	Baseline, Weeks 1, 6, 13, 26, 39, and 52
Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline to End of Study	Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. "On" time is defined as periods of good motor symptom control. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. Baseline value is defined as the average of normalized "On" time without troublesome dyskinesia collected over the 2 PD Diary days before the Enrollment visit. Positive changes from Baseline indicate improvement.	Baseline, Weeks 1, 6, 13, 26, 39, and 52
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study	The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part I assesses the participant's non-motor aspects of experiences of daily living (nM-EDL) with 13 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part I scores range from 0 to 52, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.	Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study	The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part II assesses the participant's motor experiences of daily living (M-EDL) with 13 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part II scores range from 0 to 52, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.	Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study	The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part III assesses the participant's motor examination (including Hoehn and Yahr stage) with 33 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part III scores range from 0 to 132, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.	Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study	The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part IV assesses the participant's motor complications with 6 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part IV scores range from 0 to 24, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.	Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study	The PDSS-2 consists of 15 questions that evaluate motor and non-motor symptoms at night and upon wakening, as well as disturbed sleep grouped into 3 domains: motor symptoms at night (5 items), Parkinson's Disease (PD) symptoms at night (5 items), and disturbed sleep (5 items). The frequency is assessed for the 15 sleep problems based on a 5-point Likert-type scale (ranging from 0 [never] to 4 [very often] with the exception of Question 1 score ranging from 0 [very often] to 4 [never]). Scores are calculated for each of the 3 domains as well as a total score. The PDSS-2 domain scores range from 0 to 20 and the total score is a sum of the 3 domains and ranges from 0 to 60. Higher scores indicate higher frequency and more severe impact of PD on sleep. Negative changes indicate improvement from Baseline.	Baseline, Weeks 6, 13, 26, 39, and 52
Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study	The Parkinson's Disease Questionnaire (PDQ-39) is a disease-specific instrument designed to measure aspects of health that are relevant to participants with Parkinson's Disease (PD), and which may not be included in general health status questionnaires. Each item is scored on the following 5-point scale: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always (or cannot do at all, if applicable). Higher scores are consistently associated with more severe symptoms of the disease such as tremors and stiffness. The results can be presented in either domain scores or as a summary index score. The full range of the PDQ-39 summary index score is from 0 (no patient-related symptoms/quality of life unaffected) to 100 (highest patient-related symptoms/low quality of life). Negative changes indicate improvement from Baseline.	Baseline, Weeks 6, 13, 26, 39, and 52
The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study	The EuroQol 5-dimension questionnaire (EQ-5D-5L) is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the participant's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. The health status is converted to an index value using the country-specific weighted scoring algorithm for the United States (US). The summary index value for the US ranges from a worst score of -0.109 to a best score of 1. An increase in the EQ-5D-5L total score indicates improvement.	Baseline, Weeks 6, 13, 26, 39, and 52

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2019
• Primary Completion (Actual): August 17, 2022
• Study Completion (Actual): August 17, 2022

Study Registration Dates

• First Submitted: December 18, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: ABBV-951; Parkinson's Disease (PD); Levodopa/Carbidopa
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: M15-741; 2018-002144-85 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No