A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations

A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor Fluctuations

To evaluate the safety and efficacy of IPX203 (carbidopa and levodopa) extended-release capsules (IPX203 ER CD-LD) in comparison to immediate release (IR) CD-LD in the treatment of CD-LD-experienced participants with Parkinson's disease (PD) who have motor fluctuations.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease (Disorder)
• Intervention / Treatment: Drug: IR CD-LD; Drug: IPX203 ER CD-LD; Other: Placebo Matching IPX203; Other: Placebo Matching IR CD-LD

Detailed Description

This was a multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group study. The study consisted of a 3-week, open-label IR CD-LD dose adjustment period; a 4-week, open-label period for conversion to IPX203; followed by a 13-week double-blind treatment period with participants randomized in a 1:1 ratio, stratified by center, to receive either IPX203 (with matching IR CD-LD placebo) or IR CD-LD (with matching IPX203 placebo).

• Study Type: Interventional
• Enrollment (Actual): 630
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia, 65691
    • Fakultni nemocnice u sv. Anny v Brne, I. neurologicka klinika (704)
  • Choceň, Czechia, 56501
    • Neurohk, s.r.o (701)
  • Pardubice, Czechia, 53203
    • Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice, Neurologicka klinika (702)
  • Praha 10, Czechia, 10000
    • CLINTRIAL s.r.o. (703)
  • Praha 5, Czechia, 15000
    • AXON Clinical, s.r.o. (700)
  • Praha 6, Czechia, 160 00
    • Neurologicka ordinace FORBELI s.r.o.(706)
• France
  • Clermont-Ferrand Cedex 1, France, 63003
    • CHU de Clermont-Ferrand - Hopital Gabriel Montpied (404)
  • Montpellier Cedex 5, France, 34295
    • CHU de Montpellier, Hopital Gui de Chauliac(405)
  • Nice, France, 06002
    • Centre Hospitalier Universitaire de Nice (400)
  • Poitiers Cedex, France, 86021
    • INSERM, Centre d'investigation Clinique 1402, CHU de Poitiers (402)
  • Toulouse Cedex 9, France, 31059
    • Centre d'Investigation Clinique 1436-CHU Purpan-Hopital Pierre Paul Riquet (403)
• Germany
  • Berlin, Germany, 12163
    • Dr. med. REINHARDT Ehret Neurologie Berlin Schlobstr. 29 (309)
  • Bavaria
    • München, Bavaria, Germany, 80331
      • Curiositas ad sanum, Studien und Beratungs GmbH(311)
    • München, Bavaria, Germany, 81675
      • Klinikum rechts der lsar der TUM, Klinik und Poliklinik fur Neurologie (303)
  • Brandenburg
    • Beelitz-Heilstatten, Brandenburg, Germany, 14547
      • Kliniken Beelitz GmbH, neurologisches Fachkrankenhaus fur Bewegungsstorungen/Parkinson (300)
  • Lower Saxony
    • Westerstede, Lower Saxony, Germany, 26655
      • Gemeinschaftspraxis Dr. med. Joachim Springub/ Wolfgang Schwarz, Studienzentrum Nord-West (306)
  • North Rhine-Westphalia
    • Bochum, North Rhine-Westphalia, Germany, 44791
      • St. Josef-Hospital, Universitatsklinik fur Neurologie, Klinisches Forschungszentrum fur Neurodegeneration (301)
  • Oberbayern (Upper Bavaria)
    • Haag In Oberbayern, Oberbayern (Upper Bavaria), Germany, 83527
      • Klinik Haag i. OB, Geriatric Hospital (305)
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Universitatsklinikum Carl Gustav Carus, Klinik und Poliklinik fur Neurologie (307)
• Italy
  • Italy/Catania/Sicily
    • Catania, Italy/Catania/Sicily, Italy, 95123
      • Department "G.F. Ingrassia" Section of neuroscience-Policlinico "Vittorio Emanuele" (608)
  • Italy/Chieti/Abbruzzo
    • Chieti, Italy/Chieti/Abbruzzo, Italy, 66100
      • Università G. D'annunzio CeSi Met (604)
  • Italy/Frosinone/Lazio
    • Cassino, Italy/Frosinone/Lazio, Italy, 03043
      • Centro Ricerca Parkinson San Raffaele Cassino (601)
  • Italy/Pavia/Lombardia
    • Pavia, Italy/Pavia/Lombardia, Italy, 27100
      • Fondazione lstituto Neurologico Nazionale "C. Mondino" (606)
  • Italy/Pisa/Toscana
    • Pisa, Italy/Pisa/Toscana, Italy, 56126
      • Azienda Ospedaliero-Universitaria Pisana (602)
  • Italy/Roma/Lazio
    • Roma, Italy/Roma/Lazio, Italy, 00133
      • University of Rome Tor Vergata/Hospital Tor Vergata (605)
    • Roma, Italy/Roma/Lazio, Italy, 00163
      • IRCCS San Raffaele Pisana (600)
    • Roma, Italy/Roma/Lazio, Italy, 00189
      • Department of Neuroscience, Mental Health and Sensory System (NeSMOS), Sapienza University (603)
• Poland
  • Bydgoszcz, Poland, 85-163
    • Centrum Medyczne Neuromed (803)
  • Kraków, Poland, 30-394
    • Szpital Sw. Rozy (805)
  • Kraków, Poland, 31-505
    • Krakowska Akademia Neurologii Sp. z o.o.(802)
  • Lublin, Poland, 20-064
    • NZOZ Neuromed M. i M Nastaj Spolka Partnerska(800)
  • Poznań, Poland, 61-853
    • NZOZ Neuro-Kard Ilkowski i Partnerzy Spolka Partnerska Lekarzy (801)
  • Siemianowice Śląskie, Poland, 41-100
    • Neuro-Care Sp. z o.o. sp. k.(804)
  • Warszawa, Poland, 01-684
    • Centrum Medyczne NeuroProtect (806)
• Spain
  • Barcelona, Spain, 08028
    • Hospital Universitario Quiron Dexeus (501)
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d' Hebron (505)
  • Barcelona, Spain, 08035
    • Hospitalaries Del Sagrat Cor De Jesus Hospital Sant Rafael (516)
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona (507)
  • Barcelona, Spain, 08041
    • Hospital De La Santa Creu i Sant Pau (502)
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal (500)
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa (508)
  • Madrid, Spain, 28703
    • Hospital Universitario Infanta Sofia (513)
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio (503)
  • Valencia, Spain, 46026
    • Hospital Universitario y politecnico La Fe (515)
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Hospital Genral Universitario de Elche (509)
  • Barcelona
    • Sant Cugat Del Vallès, Barcelona, Spain, 08190
      • Hospital Universitari General de Catalunya (504)
    • Terrassa, Barcelona, Spain, 08222
      • Hospital Universitari Mutua Terrassa (506)
  • Gipuzkoa
    • San Sebastian, Gipuzkoa, Spain, 20014
      • Policlinica Gipuzkoa, S.A.,(511)
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universidad de Navarra (512)
• United Kingdom
  • London, United Kingdom, W1G9JF
    • Re:Cognition Health Ltd (202)
  • London, United Kingdom, W68RF
    • Imperial College Healthcare NHS Trust (200)
  • Devon
    • Plymouth, Devon, United Kingdom, PL68BT
      • Re: Cognition Health Ltd(205)
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Xenoscience, Inc. (102)
    • Phoenix, Arizona, United States, 85013
      • St. Joseph's Hospital & Medical Center/ Barrow Neurological Institute (156)
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences (117)
    • Little Rock, Arkansas, United States, 72205
      • Clinical Trials, Inc. (113)
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Health Care, Department of Neurology (137)
    • Los Angeles, California, United States, 90033
      • Keck School of Medicine of USC/University of Southern California (106)
    • Newport Beach, California, United States, 92663
      • Hoag Memorial Hospital Presbyterian (134)
    • Pasadena, California, United States, 91105
      • SC3 Research - Pasadena (148)
    • Reseda, California, United States, 91335
      • SC3 Research - Reseda (146)
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital Anschutz Outpatient Pavilion (120)
    • Englewood, Colorado, United States, 80113
      • Rocky Mountain Movement Disorders Center (116)
  • Delaware
    • Newark, Delaware, United States, 19713
      • Christiana Care Neurology Specialists (153)
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research Institute (136)
    • Aventura, Florida, United States, 33180
      • Visionary Investigators Network (168)
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Disease and Movement Disorders Center of Boca Raton (121)
    • Boca Raton, Florida, United States, 33131
      • University of Miami-UHealth at Boca Raton (152)
    • Hallandale Beach, Florida, United States, 33009
      • MD Clinical (111)
    • Hollywood, Florida, United States, 33024
      • Infinity Clinical Research (104)
    • Jacksonville, Florida, United States, 32209
      • University of Florida Health Science Center(129)
    • Maitland, Florida, United States, 32751
      • Neurology Associates, P.A. (125)
    • Miami, Florida, United States, 33136
      • University of Miami (149)
    • Miami, Florida, United States, 33165
      • Medical Professional Clinical Research Center, INC (163)
    • Port Charlotte, Florida, United States, 33980
      • Parkinsons's Disease Treatment Center of Southwest Florida (131)
    • Sunrise, Florida, United States, 33351
      • Infinity Clinical Research, LLC (105)
    • Tampa, Florida, United States, 33613
      • University of South Florida (114)
    • West Palm Beach, Florida, United States, 33407
      • Premiere Research Institute at Palm Beach Neurology (174)
    • Winter Park, Florida, United States, 32792
      • Charter Research (166)
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory Brain Health Center (110)
    • Decatur, Georgia, United States, 30033
      • NeuroStudies.net, LLC (155)
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medical Group Neurology Clinic(145)
    • Winfield, Illinois, United States, 60190
      • Central DuPage Hospital (151)
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health Neuroscience Center (164)
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center (118)
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Quest Research Institute (103)
    • West Bloomfield, Michigan, United States, 483222
      • Henry Ford West Bloomfield Hospital (100)
  • Minnesota
    • Golden Valley, Minnesota, United States, 55427
      • Struthers Parkinson's Center (130)
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University (109)
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Cleveland Clinic Lou Ruvo Center for Brain Health (142)
    • Las Vegas, Nevada, United States, 89118
      • Roseman Medical Research Institute/Roseman Medical Group (154)
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College (139)
    • New York, New York, United States, 10019
      • Mount Sinai West-Department of Neurology(172)
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health Sciences (127)
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Ucgni (133)
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center (123)
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic (144)
    • Toledo, Ohio, United States, 43614
      • University of Toledo, Gardner-McMaster Parkinson Center (122)
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Movement Disorder Clinic of Oklahoma (115)
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina (150)
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • The Vanderbilt Clinic(158)
  • Texas
    • Dallas, Texas, United States, 75251
      • Neurology Consultants of Dallas, PA (108)
    • Dallas, Texas, United States, 75390-9184
      • University of Texas Southwestern Medical Center (143)
    • Houston, Texas, United States, 77030
      • Houston Methodist Neurological Institute/Movement Disorders Clinic (135)
  • Virginia
    • Alexandria, Virginia, United States, 22311
      • Inova Medical Group-Neurology I (147)
    • Henrico, Virginia, United States, 23233
      • VCU Health - Neuroscience, Orthopaedic and Wellness Center (124)
  • Washington
    • Kirkland, Washington, United States, 98034
      • Booth Gardner Parkinson's Care Center (112)
    • Spokane, Washington, United States, 99202
      • Inland Northwest Research (119)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female participants diagnosed at age ≥ 40 years with PD, consistent with the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria and who are being treated with stable regimens of CD-LD but experiencing motor fluctuations.
• Able to provide written informed consent prior to the conduct of any study-specific procedures.
• Female participants of childbearing potential must have a negative urine pregnancy test at Screening Visit.
• Negative urine screen for drugs of abuse and negative alcohol breath test at Screening.
• Hoehn and Yahr Stages 1, 2, 3, or 4 in the "On" state (part of Movement Disorders Society version of the Unified Parkinson's Disease Rating Scale [MDS-UPDRS] Part III)
• Agrees to use a medically acceptable method of contraception throughout the study and for 6 weeks after completing the study. Medically acceptable methods of contraception that may be used by the participant and/or partner include but are not limited to: abstinence, oral contraception, NuvaRing or transdermal systems, diaphragm with vaginal spermicide, intrauterine device, condom and partner using vaginal spermicide, surgical sterilization (6 months), progestin implant or injection, or postmenopausal female (no menstrual period for ˃ 2 years) or vasectomy (˃ 6 months).
• Montreal Cognitive Assessment (MoCA) score ≥ 24 at Screening Visit in "On" state.
• Able to differentiate "On" state from "Off" state as determined by at least 75% concordance with a trained rater in "On/Off" ratings for 8 ratings over a 4-hour training period. The concordance must include at least 1 "On" and 1 "Off" rating and must be achieved within two 4-hour training sessions.
• Able and willing to comply with the protocol, including completion of diaries and availability for all study visits.
• Responsive to CD-LD therapy and currently being treated on a stable regimen with CD-LD for at least 4 weeks prior to Visit 1.
• At Screening, the participant has predictable "Off" periods.

Exclusion Criteria:

• Received any investigational medications within 30 days or 5 times the half-life, whichever is longer, prior to Visit 1.
• Female participants who are currently breastfeeding or lactating.
• Had prior neurosurgical treatment for PD or if such procedure is planned or anticipated during the study period.
• Allergic to any excipient in the study drugs.
• History of medical conditions or of a prior surgical procedure that would interfere with LD absorption, such as gastrectomy, proximal small-bowel resection, or bariatric surgery.
• History of upper gastrointestinal hemorrhage in participants with peptic ulcer disease within the past 5 years.
• History of glaucoma with intraocular pressures that are elevated despite appropriate medical management.
• History of seizure or epilepsy and experienced at least 1 seizure during the past 12 months or has not been compliant with medically recommended therapy or visits.
• History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias that are not controlled with medical and/or surgical interventions. A recent (≤ 12 months) history of myocardial infarction with secondary arrhythmias is exclusionary regardless of the therapeutic control.
• History of neuroleptic malignant syndrome or of nontraumatic rhabdomyolysis.
• Liver enzyme values ≥ 2.5 times the upper limit of normal; or history of severe hepatic impairment.
• Serum creatinine level ≥ 1.75 times the upper limit of normal; or requires dialysis at the time of Screening.
• Participant with a history of malignant melanoma or with a suspicious undiagnosed skin lesion which in the opinion of the investigator could be melanoma.
• History of drug or alcohol abuse within the 12 months prior to Screening.
• Received within 4 weeks of Screening or planning to take during participation in the clinical study:
• Any doses of a CR CD-LD apart from a single daily bedtime dose, any doses of Rytary, additional CD (eg, Lodosyn) or benserazide (eg, Serazide), or catechol-O-methyl transferase inhibitors (entacapone or tolcapone) or medications containing these inhibitors (Stalevo),
• Nonselective monoamine oxidase inhibitors (MAOI), apomorphine, or antidopaminergic agents, including antiemetics.
• Employees or family members of the investigator, study site, or sponsor.
• Participants who have previously participated in an IPX203 study.
• Participants who, in the opinion of the clinical investigator, should not participate in the study.
• Based on clinical assessment, participant does not adequately comprehend the terminology needed to complete the PD diary.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: IR CD-LD - Dose Adjustment; Participants started on the same dose as the pre-study dosing regimen of IR CD-LD and then received dose adjusted IR CD-LD tablets daily orally, for a period of 3 weeks. If the participant was taking controlled release carbidopa-levodopa (CR CD-LD), the CR CD-LD was discontinued and substituted with a 1:1 milligram-equivalent dose of IR CD-LD.	Drug: IR CD-LD; Active comparator - IR CD-LD; Other Names: Generic for Sinemet tablets
EXPERIMENTAL: IPX203 - Dose Conversion; Participants received extended release (ER) CD-LD (IPX203) capsules orally, every 6 - 12 hours for a period of 4 weeks at a dose based on their most frequent stable dose of IR CD-LD in dose adjustment period. Participant with most frequent stable dose of 25-100 milligrams (mg) IR CD-LD received 70 - 280 mg IPX203 thrice daily (TID); >25-100 - 37.5-150 mg IR CD-LD received 105-420 mg IPX203 TID; >37.5-150 - 50-200 mg IR CD-LD received 140-560 mg IPX203 TID; >50 - 200 mg IR CD-LD received 175-700 mg IPX203 TID. Participants who received a daily total dose of less than 125-500 mg IR CD-LD in dose adjustment received IPX203 every 12 hours. After initial dose conversion from IR CD-LD to IPX203 as per above mentioned dose conversion schedule, the dose of IPX203 could be further adjusted during the 4 week dose conversion period.	Drug: IPX203 ER CD-LD; Investigational formulation - ER CD-LD; Other Names: IPX203 extended-release capsules
EXPERIMENTAL: IPX203 - Double-Blind Maintenance; Participants received IPX203 capsules orally, every 6 - 12 hours for 13 weeks at a stable dose established at the end of dose conversion period along with placebo matched to IR CD-LD.	Drug: IPX203 ER CD-LD; Investigational formulation - ER CD-LD; Other Names: IPX203 extended-release capsules; Other: Placebo Matching IPX203; Double dummy placebo capsules
ACTIVE_COMPARATOR: IR CD-LD - Double -Blind Maintenance; Participants received IR CD-LD tablets daily orally, for 13 weeks at a stable dose established at the end of dose adjustment period along with placebo matched to IPX203.	Drug: IR CD-LD; Active comparator - IR CD-LD; Other Names: Generic for Sinemet tablets; Other: Placebo Matching IR CD-LD; Double dummy placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in "Good on" Time Per Day at Week 20/Early Termination (ET)	"Good on" time was derived from the 3-day PD Diaries. For each day, "Good on" time was calculated by adding the number of half-hour intervals in which either an "On" without dyskinesia or "On" with nontroublesome dyskinesia was checked. Baseline was defined as data obtained from PD Diary collected over 3 days prior to Week 7/Randomization. Least square mean (LSM), standard error (SE), confidence interval (CI), Mixed model repeated measures (MMRM), Change from baseline (CFB).	Baseline (Week 7) and Week 20/ET

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in "Off" Time Per Day at Week 20/ET	"Off" time was derived from the 3-day PD Diaries. For each day, "Off" time was calculated by adding the number of half-hour intervals in which the Status "Off" was checked. Baseline was defined as data obtained from PD Diary collected over 3 days prior to Week 7/Randomization.	Baseline (Week 7) and Week 20/ET
Percentage of Participants With Either "Much Improved" or "Very Much Improved" in Patient Global Impression of Change (PGI-C) Scores at Week 20/ET	The Patient Global Impression of Change (PGIC) is self assessment questionnaire which was used by participants to compare his/her condition on a 7-point scale ranging from 1-Very Much Worse, 2-Much Worse, 3-Minimally Worse, 4-No Change, 5-Minimally Improved, 6-Much Improved, 7-Very Much Improved. Percentage of participants with either "Much Improved" or "Very Much Improved" was reported.	Week 20/ET
Change From Baseline in The Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III at Week 20/ET	MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 34 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-234). Part III score ranges from 0 to 136. A higher score indicated more severe symptoms of PD. Baseline was defined as data obtained from PD Diary collected over 3 days prior to Week 7/Randomization.	Baseline (Week 7) and Week 20/ET
Change From Baseline in The Sum of MDS-UPDRS Part II and Part III at Week 20/ET	MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 34 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-234). The scale range for Part II+III score is 0-188. A higher score indicated more severe symptoms of PD. Baseline was defined as data obtained from PD Diary collected over 3 days prior to Week 7/Randomization.	Baseline (Week 7) and Week 20/ET

Collaborators and Investigators

• Sponsor: Impax Laboratories, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 6, 2018
• Primary Completion (ACTUAL): June 15, 2021
• Study Completion (ACTUAL): June 15, 2021

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (ACTUAL): September 14, 2018

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Idiopathic Parkinson's Disease; Lewy Body Parkinson's Disease; Paralysis Agitans; Primary Parkinsonism
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Disease; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Immunologic Factors; Dopamine Agonists; Dopamine Agents; Adjuvants, Immunologic; Antiparkinson Agents; Anti-Dyskinesia Agents; Carbidopa, levodopa drug combination
• Other Study ID Numbers: IPX203-B16-02; 2018-002233-37 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No