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

NCT03877510 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: IPX203-B16-032018-002234-21
• Study Type: interventional
• Target: 419
• Locations: 8 countries
• Sites: 98

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

motor fluctuations; IPX203

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (28)

• Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Total

  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

  Baseline, Month 9/ET

• Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I

  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

  Baseline, Month 9/ET

• Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part II

  Baseline, Month 3, Month 6, and Month 9/ET

Study Arms (1)

Open Label IPX203

EXPERIMENTAL

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

Interventions

IPX203 DRUG

IPX203 extended release capsules

Open Label IPX203

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Impax Laboratories, LLC: lead

Study Sites (98)

Xenoscience, Inc (102)

Phoenix, Arizona, 85004, United States

Location

St. Joseph's Hospital & Medical Center - Barrow Neurological Institute (156)

Phoenix, Arizona, 85013, United States

Location

Clinical Trials, Inc (113)

Little Rock, Arkansas, 72205, United States

Location

University of Arkansas for Medical Sciences (117)

Little Rock, Arkansas, 72205, United States

Location

Keek School of Medicine of USC/ University of Southern California (106)

Los Angeles, California, 90033, United States

Location

Hoag Memorial Hospital Presbyterian (134)

Newport Beach, California, 92663, United States

Location

SC3 Research-Pasadena (148)

Pasadena, California, 91105, United States

Location

SC3 Research-Reseda (146)

Reseda, California, 91335, United States

Location

University of Colorado Hospital Anschutz Outpatient Pavilion (120)

Aurora, Colorado, 80045, United States

Location

Rocky Mountain Movement Disorders (116)

Englewood, Colorado, 80113, United States

Location

ChristianaCare Neurology Specialists (153)

Newark, Delaware, 19713, United States

Location

JEM Research Institute (136)

Atlantis, Florida, 33462, United States

Location

Visionary Investigators Network (168)

Aventura, Florida, 33180, United States

Location

UHealth at Boca Raton (152)

Boca Raton, Florida, 33431, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton (121)

Boca Raton, Florida, 33486, United States

Location

Infinity Clinical Research LLC (104)

Hollywood, Florida, 33024, United States

Location

University of Florida Health Science Center (129)

Jacksonville, Florida, 32209, United States

Location

Neurology Associates, P.A. (125)

Maitland, Florida, 32751, United States

Location

University of Miami (149)

Miami, Florida, 33136, United States

Location

Medical Professional Clinical Research Center, Inc. (163)

Miami, Florida, 33165, United States

Location

Parkinson's Disease Treatment Center of Southwest Florida (131)

Port Charlotte, Florida, 33980, United States

Location

Infinity Clinical Research, LLC (105)

Sunrise, Florida, 33351, United States

Location

University of South Florida (114)

Tampa, Florida, 33615, United States

Location

Premiere Research Institute at Palm Beach Neurology (174)

West Palm Beach, Florida, 33407, United States

Location

Charter Research (166)

Winter Park, Florida, 32792, United States

Location

Emory Brain Health Center (110)

Atlanta, Georgia, 30329, United States

Location

NeuroStudies.net, LLC (155)

Decatur, Georgia, 30033, United States

Location

Northwestern Medical Group Neurology Clinic (145)

Chicago, Illinois, 60611, United States

Location

Central DuPage Hospital (151)

Winfield, Illinois, 60190, United States

Location

Indiana University Health Neuroscience Center(164)

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center (118)

Kansas City, Kansas, 66160, United States

Location

Quest Research Institute (103)

Farmington Hills, Michigan, 48334, United States

Location

Henry Ford West Bloomfield Hospital(100)

West Bloomfield, Michigan, 48322, United States

Location

Washington University (109)

St Louis, Missouri, 63110, United States

Location

Roseman Medical Research Institute / Roseman Medical Group (154)

Las Vegas, Nevada, 17601, United States

Location

Cleveland Clinic Lou Ruvo Center for Brain Health (142)

Las Vegas, Nevada, 89106, United States

Location

Albany Medical College (139)

Albany, New York, 12208, United States

Location

Ucgni (133)

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Cleveland Medical Center (123)

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic(144)

Cleveland, Ohio, 44195, United States

Location

University of Toledo, Gardner-McMaster Parkinson Center (122)

Toledo, Ohio, 43614, United States

Location

The Movement Disorder Clinic of Oklahoma (115)

Tulsa, Oklahoma, 74136, United States

Location

The Vanderbilt Clinic (158)

Nashville, Tennessee, 37232, United States

Location

Neurology Consultants of Dallas, PA (108)

Dallas, Texas, 75251, United States

Location

University of Texas Southwestern Medical Center (143)

Dallas, Texas, 75390-9184, United States

Location

Houston Methodist Neurological Institute/Movement Disorders Clinic (135)

Houston, Texas, 77030, United States

Location

Inova Neurology- Fairfax (147)

Fairfax, Virginia, 17601, United States

Location

VCU Health- Neuroscience Orthopaedic and Wellness Center(124)

Henrico, Virginia, 23233, United States

Location

Booth Gardner Parkinson's Care Center (112)

Kirkland, Washington, 98034, United States

Location

Inland Northwest Research (119)

Spokane, Washington, 99202, United States

Location

Fakultni nemocnice u sv. Anny v Brne, I. neurologicka klinika (704)

Brno, 65691, Czechia

Location

NEUROHK. s.r.o. (701)

Choceň, 56501, Czechia

Location

Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice, Neurologicka klinika (702)

Pardubice, 53203, Czechia

Location

CLINTRIAL s.r.o. (703)

Prague, 10000, Czechia

Location

AXON Clinical. s.r.o. (700)

Prague, 15000, Czechia

Location

Neurologicka ordinace FORBELI s.r.o. (706)

Prague, 16000, Czechia

Location

CHU de Clermont-Ferrand-Hopital Gabriel Montpied (404)

Clermont-Ferrand, 63003, France

Location

CHU de Montpellier, Hopital Gui de Chauliac (405)

Montpellier, 34295, France

Location

Centre Hospitalier Universitaire de Nice (400)

Nice, 06002, France

Location

Centre d'lnvestigation Clinique 1436- CHU Purpan- Hopital Pierre Paul Riquet (403)

Toulouse, 31059, France

Location

Kliniken Beelitz GmbH, neurologisches Fachkrankenhaus fur Bewegungsstorungen/Parkinson (300)

Beelitz-Heilstätten, Beelitz, 14547, Germany

Location

St. Josef-Hospital, Universitatsklinik fur Neurologie Klinisches Forschungszentrum fur Neurodegeneration (301)

Bochum, Gudrunstabe 56, 44791, Germany

Location

Klinikum rechts der lsar der Technischen Universitat Munchen Klinik und Poliklinik fur Neurologie (303)

München, Ismaningerstrabe, 81675, Germany

Location

Dr. med. Reinhardt Ehret Neuroloqie Berlin Schlobstr. 29 (309)

Berlin, 12163, Germany

Location

Klinik Haag i. OB Geriatric Hospital Krankenhausstrabe 4 (305)

Haag in Oberbayern, 83527, Germany

Location

Gemeinschaftspraxis Dr. med. J. Springub/W. Schwarz, Studienzentrum Nordwest (306)

Westerstede, 26655, Germany

Location

Centro Ricerca Parkinson San Raffaele Cassino (601)

Cassino, Frosinone, 03043, Italy

Location

Università G. D'annunzio CeSi Met (604)

Chieti, Italy/Chieti/Abbruzzo, 66100, Italy

Location

Fondazione I st ituto Neurologico Nazionale "C. Mondino" (606)

Pavia, Italy/Pavia/Lombardia, 27100, Italy

Location

Azienda Ospedaliero-Universitaria Pisana (602)

Pisa, Italy/Pisa/Toscana, 56126, Italy

Location

IRCCS San Raffaele Pi sana (600)

Roma, Italy/Roma/Lazio, 00163, Italy

Location

Department of neuroscience, mental health and sensory system (NeSMOS), "Sapienza" University (603)

Roma, Italy/Roma/Lazio, 00189, Italy

Location

University of Rome Tor Vergata/Hospital Tor Vergata (605)

Rome, Lazio, 00133, Italy

Location

Department "G. F. Ingrassia" section of neuroscience - Policlinico "Vittorio Emanuele" (608)

Catania, Sicily, 95123, Italy

Location

Centrum Medyczne Neuromed (803)

Bydgoszcz, 85163, Poland

Location

Centrum Medyczne Linden (805)

Krakow, 30721, Poland

Location

Krakowska Akademia Neurologii Sp. Zo.o.(802)

Krakow, 31-505, Poland

Location

NZOZ Neuromed M. i M. Nastaj Sp.p. (800)

Lublin, 20-064, Poland

Location

NZOZ Neuro-Kard Ilkowski i Partnerzy Spolka Partnerska Lekarzy (801)

Poznan, 61853, Poland

Location

Neuro-Care Sp. z o.o. sp. k. (804)

Siemianowice Śląskie, 41100, Poland

Location

Centrum Medycme NeuroProtect (806)

Warsaw, 01-684, Poland

Location

Hospital General Universitario de Elche (509)

Elche, Alicante, 03203, Spain

Location

Hospital Universitari General de Catalunya (504)

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Hospital Universitari Mutua Terrassa (506)

Terrassa, Barcelona, 08222, Spain

Location

Policlinica Gipuzkoa, S.A (511)

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

Location

Clinica Universidad de Navarra (512)

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Quiron Dexeus (501)

Barcelona, 08028, Spain

Location

Germanes Hospitalaries Del Sagrat Cor De Jesus Hospital Sant Rafael (516)

Barcelona, 08035, Spain

Location

Hospital Universitario Vall d'Hebron (505)

Barcelona, 08035, Spain

Location

Hospital de Ia Santa Creu i Sant Pau (502)

Barcelona, 08041, Spain

Location

Hospital Universitario de Ia Princesa (508)

Madrid, 28006, Spain

Location

Hospital Universitario Ramon y Cajal (500)

Madrid, 28034, Spain

Location

Hospital Universitario Infanta Sofia(513)

Madrid, 28703, Spain

Location

Hospital Universitario Virgen del Rocio (503)

Seville, 41013, Spain

Location

Hospital Universitario y Politecnico La Fe Avenida Fernando Abril Martorell (515)

Valencia, 46026, Spain

Location

Re:Cognition Health Ltd (205)

Plymouth, Devon, PL68BT, United Kingdom

Location

Imperial College Healthcare NI-lS Trust (200)

London, W68RF, United Kingdom

Location

Re:Cognition Health Ltd (202)

London, WlG9JF, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Pamela Fitzpatrick, Senior Director, Specialty Regulatory Affairs
• Organization: Impax Laboratories, LLC

pfitzpatrick@amneal.com

631-633-2104

Study Officials

• Impax Impax Study Director

  Impax Laboratories, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 15, 2019
• Study Start: April 3, 2019
• Primary Completion: March 21, 2022
• Study Completion: March 21, 2022
• Last Updated: July 13, 2023
• Results First Posted: June 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (7); IT (8); CZ (6); DE (6); ES (14); FR (4); US (50); GB (3)