Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations

An Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients With Motor Fluctuations

The purpose of this study is to evaluate the long-term safety and clinical utility of IPX203 in the treatment of participants with advanced Parkinson's disease (PD) who have motor fluctuations.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: IPX203

Detailed Description

This is a 9-month, multicenter open-label safety extension study. Participants who have successfully completed Study NCT03670953 [A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 with Immediate-Release (IR) Carbidopa-Levodopa (CD-LD) in Parkinson's Disease Patients with Motor Fluctuations] may have the opportunity to enroll in this open-label study.

• Study Type: Interventional
• Enrollment (Actual): 419
• 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, 16000
    • 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)
  • Toulouse Cedex 9, France, 31059
    • Centre d'lnvestigation Clinique 1436- CHU Purpan- Hopital Pierre Paul Riquet (403)
• Germany
  • Berlin, Germany, 12163
    • Dr. med. Reinhardt Ehret Neuroloqie Berlin Schlobstr. 29 (309)
  • Haag In Oberbayern, Germany, 83527
    • Klinik Haag i. OB Geriatric Hospital Krankenhausstrabe 4 (305)
  • Westerstede, Germany, 26655
    • Gemeinschaftspraxis Dr. med. J. Springub/W. Schwarz, Studienzentrum Nordwest (306)
  • Beelitz
    • Beelitz-Heilstätten, Beelitz, Germany, 14547
      • Kliniken Beelitz GmbH, neurologisches Fachkrankenhaus fur Bewegungsstorungen/Parkinson (300)
  • Gudrunstabe 56
    • Bochum, Gudrunstabe 56, Germany, 44791
      • St. Josef-Hospital, Universitatsklinik fur Neurologie Klinisches Forschungszentrum fur Neurodegeneration (301)
  • Ismaningerstrabe
    • München, Ismaningerstrabe, Germany, 81675
      • Klinikum rechts der lsar der Technischen Universitat Munchen Klinik und Poliklinik fur Neurologie (303)
• Italy
  • Frosinone
    • Cassino, Frosinone, Italy, 03043
      • Centro Ricerca Parkinson San Raffaele Cassino (601)
  • Italy/Chieti/Abbruzzo
    • Chieti, Italy/Chieti/Abbruzzo, Italy, 66100
      • Università G. D'annunzio CeSi Met (604)
  • Italy/Pavia/Lombardia
    • Pavia, Italy/Pavia/Lombardia, Italy, 27100
      • Fondazione I st ituto 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, 00163
      • IRCCS San Raffaele Pi sana (600)
    • Roma, Italy/Roma/Lazio, Italy, 00189
      • Department of neuroscience, mental health and sensory system (NeSMOS), "Sapienza" University (603)
  • Lazio
    • Roma, Lazio, Italy, 00133
      • University of Rome Tor Vergata/Hospital Tor Vergata (605)
  • Sicily
    • Catania, Sicily, Italy, 95123
      • Department "G. F. Ingrassia" section of neuroscience - Policlinico "Vittorio Emanuele" (608)
• Poland
  • Bydgoszcz, Poland, 85163
    • Centrum Medyczne Neuromed (803)
  • Kraków, Poland, 30721
    • Centrum Medyczne Linden (805)
  • Kraków, Poland, 31-505
    • Krakowska Akademia Neurologii Sp. Zo.o.(802)
  • Lublin, Poland, 20-064
    • NZOZ Neuromed M. i M. Nastaj Sp.p. (800)
  • Poznań, Poland, 61853
    • NZOZ Neuro-Kard Ilkowski i Partnerzy Spolka Partnerska Lekarzy (801)
  • Siemianowice Śląskie, Poland, 41100
    • Neuro-Care Sp. z o.o. sp. k. (804)
  • Warszawa, Poland, 01-684
    • Centrum Medycme NeuroProtect (806)
• Spain
  • Barcelona, Spain, 08028
    • Hospital Universitario Quiron Dexeus (501)
  • Barcelona, Spain, 08035
    • Germanes Hospitalaries Del Sagrat Cor De Jesus Hospital Sant Rafael (516)
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron (505)
  • Barcelona, Spain, 08041
    • Hospital de Ia Santa Creu i Sant Pau (502)
  • Madrid, Spain, 28006
    • Hospital Universitario de Ia Princesa (508)
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal (500)
  • 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 Avenida Fernando Abril Martorell (515)
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Hospital General Universitario de Elche (509)
  • Barcelona
    • Sant Cugat Del Vallès, Barcelona, Spain, 08195
      • Hospital Universitari General de Catalunya (504)
    • Terrassa, Barcelona, Spain, 08222
      • Hospital Universitari Mutua Terrassa (506)
  • Gipuzkoa
    • Donostia 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, W68RF
    • Imperial College Healthcare NI-lS Trust (200)
  • London, United Kingdom, WlG9JF
    • Re:Cognition Health Ltd (202)
  • 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
      • Clinical Trials, Inc (113)
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences (117)
  • California
    • Los Angeles, California, United States, 90033
      • Keek 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 (116)
  • Delaware
    • Newark, Delaware, United States, 19713
      • ChristianaCare 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, 33431
      • UHealth at Boca Raton (152)
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Disease and Movement Disorders Center of Boca Raton (121)
    • Hollywood, Florida, United States, 33024
      • Infinity Clinical Research LLC (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
      • Parkinson's Disease Treatment Center of Southwest Florida (131)
    • Sunrise, Florida, United States, 33351
      • Infinity Clinical Research, LLC (105)
    • Tampa, Florida, United States, 33615
      • 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, 48322
      • Henry Ford West Bloomfield Hospital(100)
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University (109)
  • Nevada
    • Las Vegas, Nevada, United States, 17601
      • Roseman Medical Research Institute / Roseman Medical Group (154)
    • Las Vegas, Nevada, United States, 89106
      • Cleveland Clinic Lou Ruvo Center for Brain Health (142)
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College (139)
  • 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
      • The Movement Disorder Clinic of Oklahoma (115)
  • 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
    • Fairfax, Virginia, United States, 17601
      • Inova Neurology- Fairfax (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: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Successfully completed Study IPX203-B16-02
• 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 the baseline visit (Visit 1).
• Agrees to use a medically acceptable method of contraception throughout the study and for 6 weeks after completing the study.

Exclusion Criteria:

• Intends to use any doses of Rytary® or Duopa™ during this study.
• Plans to use an investigational treatment other than IPX203 during the course of this study.
• Neurosurgical ablation treatment for PD is planned or anticipated during the study period. Implantation of a deep brain stimulator (DBS) for the treatment of PD is permitted during this study.
• Participants who, in the opinion of the clinical investigator, should not participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open Label IPX203; All participants received oral administration of extended-release capsules IPX203 dosing regimen that was determined at the end of the IPX203 dose conversion period of Study IPX203-B16-02 (NCT03670953) for nine months of open-label therapy. The dose and dosing frequency was determined by the investigator to achieve the optimal balance of efficacy and safety.	Drug: IPX203; IPX203 extended release capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events	An adverse event (AE) is any untoward medical occurrence in a participant or clinical trial participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was considered as treatment-emergent if the date of onset was on or after the date of the first open-label study drug administration in this Study IPX203-B16-03 and no later than 1 day after the last study drug dose in the study.	From first dose up to 1 day after last dose (Up to 9 months/Early Termination [ET])

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Total	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; 33 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 0-260).	Baseline, Month 3, Month 6, and Month 9/ET
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Total	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; 33 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 0-260).	Baseline, Month 9/ET
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I	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; 33 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 0-260). Part I score ranges from 0 to 52. A higher score indicated more severe symptoms of PD.	Baseline, Month 3, Month 6, and Month 9/ET
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I	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; 33 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 0-260). Part I score ranges from 0 to 52. A higher score indicated more severe symptoms of PD.	Baseline, Month 9/ET
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part II	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; 33 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 0-260). Part II score ranges from 0 to 52. A higher score indicated more severe symptoms of PD.	Baseline, Month 3, Month 6, and Month 9/ET
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part II	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; 33 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 0-260). Part II score ranges from 0 to 52. A higher score indicated more severe symptoms of PD.	Baseline, Month 9/ET
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part III	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; 33 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 0-260). Part III score ranges from 0 to 132. A higher score indicated more severe symptoms of PD.	Baseline, Month 3, Month 6, and Month 9/ET
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part III	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; 33 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 0-260). Part III score ranges from 0 to 132. A higher score indicated more severe symptoms of PD.	Baseline, Month 9/ET
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part IV	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; 33 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 0-260). Part IV score ranges from 0 to 24. A higher score indicated more severe symptoms of PD.	Baseline, Month 3, Month 6, and Month 9/ET
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part IV	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; 33 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 0-260). Part IV score ranges from 0 to 24. A higher score indicated more severe symptoms of PD.	Baseline, Month 9/ET
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Sums of Part II and Part III	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; 33 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 0-260). The scale range for Part II+III score is 0-184. A higher score indicated more severe symptoms of PD.	Baseline, Month 3, Month 6, and Month 9/ET
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Sums of Part II and Part III	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; 33 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 0-260). The scale range for Part II+III score is 0-184. A higher score indicated more severe symptoms of PD.	Baseline, Month 9/ET
Patient Global Impression of Severity (PGI-S)	The PGI-S is a participant answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Extremely severely ill.	Baseline, Month 3, Month 6, and Month 9/ET
Change From Baseline in Patient Global Impression of Severity (PGI-S)	The PGI-S is a participant answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Extremely severely ill.	Baseline, Month 9/ET
Percentage of Participants With a PGI-S ≥ 4 and PGI-S ≥ 5	The PGI-S is a participant answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Extremely severely ill.	Baseline, Month 3, Month 6, and Month 9/ET
Clinical Global Impression of Severity (CGI-S)	The CGI-S is a clinician scale rating the severity of the participant's illness on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Among the most extremely ill of participants.	Baseline, Month 3, Month 6, Month 9/ET
Change From Baseline in Clinical Global Impression of Severity (CGI-S)	The CGI-S is a clinician scale rating the severity of the participant's illness on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Among the most extremely ill of participants.	Baseline, Month 9/ET
Percentage of Participants With a CGI-S ≥ 4 and CGI-S ≥ 5	The CGI-S is a clinician scale rating the severity of the participant's illness on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Among the most extremely ill of participants.	Baseline, Month 3, Month 6, and Month 9/ET
39-item Parkinson's Disease Questionnaire (PDQ-39): Total	The PDQ-39 is a self-reported outcome of 39 questions relating to 8 domains: mobility (Questions 1-10), activities of daily living (ADL) (Questions 11-16), emotional well-being (Questions 17-22), stigma (Questions 23-26), social support (Questions 27-29), cognition (Questions 30-33), communication (Questions 34-36) and bodily discomfort (Questions 37-39). Each question is answered on a 5-point scale from 0 (Never) to 4 (Always / Cannot Do At All). Scores are calculated by summing the answers to the questions in the domain and converting to a scale from 0 to 100. Higher scores are associated with the more severe symptoms of the disease such as tremor and stiffness.	Baseline, Month 3, Month 6, and Month 9/ET
Change From Baseline in PDQ-39: Total	The PDQ-39 is a self-reported outcome of 39 questions relating to 8 domains: mobility (Questions 1-10), activities of daily living (ADL) (Questions 11-16), emotional well-being (Questions 17-22), stigma (Questions 23-26), social support (Questions 27-29), cognition (Questions 30-33), communication (Questions 34-36) and bodily discomfort (Questions 37-39). Each question is answered on a 5-point scale from 0 (Never) to 4 (Always / Cannot Do At All). Scores are calculated by summing the answers to the questions in the domain and converting to a scale from 0 to 100. Higher scores are associated with the more severe symptoms of the disease such as tremor and stiffness.	Baseline, Month 9/ET
Parkinson Anxiety Scale (PAS): Total	The PAS is a three part participant answered assessment. Part 1 has 5 questions measuring persistent anxiety. Each question ranges from 0 - not at all, or never to 4 severe, or nearly always. Best score is 0; worst score is 20. Part 2 has 4 questions measuring episodic anxiety. Each question ranges from 0 - never to 4 - nearly always. Best score is 0; worst score is 16. Part 3 has 3 questions measuring avoidance behavior. Each question ranges from 0, never to 4 nearly always. Best score is 0; worst score is 12. Totals for all three parts are summed and ranges from 0 to 48, higher scores are associated with the more severe symptoms.	Baseline, Month 3, Month 6, and Month 9/ET
Change From Baseline in Parkinson Anxiety Scale (PAS): Total	The PAS is a three part participant answered assessment. Part 1 has 5 questions measuring persistent anxiety. Each question ranges from 0 - not at all, or never to 4 severe, or nearly always. Best score is 0; worst score is 20. Part 2 has 4 questions measuring episodic anxiety. Each question ranges from 0 - never to 4 - nearly always. Best score is 0; worst score is 16. Part 3 has 3 questions measuring avoidance behavior. Each question ranges from 0, never to 4 nearly always. Best score is 0; worst score is 12. Totals for all three parts are summed and ranges from 0 to 48, higher scores are associated with the more severe symptoms.	Baseline, Month 9/ET
Non-Motor Symptom Assessment Scale (NMSS) for Parkinson's Disease (PD): Total	The NMSS assesses non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous. Severity symptoms are rated on a scale of 0-3 with 3 being most severe; and frequency on a scale of 1-4 with 4 being most frequent. Each question is answered with a severity and frequency rating which are then multiplied. The sum of the products gives the total score which ranges from 0 to 360 with a lower score more desirable than a higher score.	Baseline, Month 3, Month 6, and Month 9/ET
Change From Baseline in Non-Motor Symptom Assessment Scale (NMSS) for Parkinson's Disease (PD): Total	The NMSS assesses non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous. Severity symptoms are rated on a scale of 0-3 with 3 being most severe; and frequency on a scale of 1-4 with 4 being most frequent. Each question is answered with a severity and frequency rating which are then multiplied. The sum of the products gives the total score which ranges from 0 to 360 with a lower score more desirable than a higher score.	Baseline, Month 9/ET
Parkinson's Disease Sleep Scale-2 (PDSS-2) Total	The PDSS-2 is a 15 question participant response scale measuring the severity of sleep disturbance. Three domains are defined: disturbed sleep (Questions 1-3, 8, 14), motor symptoms at night (Questions 4-6, 12, 13), PD symptoms at night (Questions 7, 9-11, 15). Each question is rated as very often to never on a scale of 0-4. The best overall score is 0; the worst overall score is 60.	Baseline, Month 3, Month 6, and Month 9/ET
Change From Baseline in Parkinson's Disease Sleep Scale-2 (PDSS-2):Total	The PDSS-2 is a 15 question participant response scale measuring the severity of sleep disturbance. Three domains are defined: disturbed sleep (Questions 1-3, 8, 14), motor symptoms at night (Questions 4-6, 12, 13), PD symptoms at night (Questions 7, 9-11, 15). Each question is rated as very often to never on a scale of 0-4. The best overall score is 0; the worst overall score is 60.	Baseline, Month 9/ET
Treatment Satisfaction Assessment (TSA)	The TSA is a participant answered assessment rating treatment satisfaction on a scale of 1 to 7; 1 = Very much dissatisfied being least satisfied and 7 = Very much satisfied.	Month 3, Month 6 and Month 9/ET
Percentage of Participants With TSA Scores 5-7 (Satisfied) Versus Scores 1-4 (Dissatisfied or Neutral)	The TSA is a participant answered assessment rating treatment satisfaction on a scale of 1 to 7; 1 = Very much dissatisfied being least satisfied and 7 = Very much satisfied.	Month 3, Month 6, and Month 9/ET

Collaborators and Investigators

• Sponsor: Impax Laboratories, LLC
• Investigators: Study Director: Impax Impax Study Director, Impax Laboratories, LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2019
• Primary Completion (Actual): March 21, 2022
• Study Completion (Actual): March 21, 2022

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: motor fluctuations; IPX203
• 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: IPX203-B16-03; 2018-002234-21 (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