Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations
NCT ID: NCT03877510
Last Updated: 2023-07-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
419 participants
INTERVENTIONAL
2019-04-03
2022-03-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
IPX203
IPX203 extended release capsules
Interventions
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IPX203
IPX203 extended release capsules
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
No
Sponsors
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Impax Laboratories, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Impax Impax Study Director
Role: STUDY_DIRECTOR
Impax Laboratories, LLC
Locations
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Xenoscience, Inc (102)
Phoenix, Arizona, United States
St. Joseph's Hospital & Medical Center - Barrow Neurological Institute (156)
Phoenix, Arizona, United States
Clinical Trials, Inc (113)
Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences (117)
Little Rock, Arkansas, United States
Keek School of Medicine of USC/ University of Southern California (106)
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian (134)
Newport Beach, California, United States
SC3 Research-Pasadena (148)
Pasadena, California, United States
SC3 Research-Reseda (146)
Reseda, California, United States
University of Colorado Hospital Anschutz Outpatient Pavilion (120)
Aurora, Colorado, United States
Rocky Mountain Movement Disorders (116)
Englewood, Colorado, United States
ChristianaCare Neurology Specialists (153)
Newark, Delaware, United States
JEM Research Institute (136)
Atlantis, Florida, United States
Visionary Investigators Network (168)
Aventura, Florida, United States
UHealth at Boca Raton (152)
Boca Raton, Florida, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton (121)
Boca Raton, Florida, United States
Infinity Clinical Research LLC (104)
Hollywood, Florida, United States
University of Florida Health Science Center (129)
Jacksonville, Florida, United States
Neurology Associates, P.A. (125)
Maitland, Florida, United States
University of Miami (149)
Miami, Florida, United States
Medical Professional Clinical Research Center, Inc. (163)
Miami, Florida, United States
Parkinson's Disease Treatment Center of Southwest Florida (131)
Port Charlotte, Florida, United States
Infinity Clinical Research, LLC (105)
Sunrise, Florida, United States
University of South Florida (114)
Tampa, Florida, United States
Premiere Research Institute at Palm Beach Neurology (174)
West Palm Beach, Florida, United States
Charter Research (166)
Winter Park, Florida, United States
Emory Brain Health Center (110)
Atlanta, Georgia, United States
NeuroStudies.net, LLC (155)
Decatur, Georgia, United States
Northwestern Medical Group Neurology Clinic (145)
Chicago, Illinois, United States
Central DuPage Hospital (151)
Winfield, Illinois, United States
Indiana University Health Neuroscience Center(164)
Indianapolis, Indiana, United States
University of Kansas Medical Center (118)
Kansas City, Kansas, United States
Quest Research Institute (103)
Farmington Hills, Michigan, United States
Henry Ford West Bloomfield Hospital(100)
West Bloomfield, Michigan, United States
Washington University (109)
St Louis, Missouri, United States
Roseman Medical Research Institute / Roseman Medical Group (154)
Las Vegas, Nevada, United States
Cleveland Clinic Lou Ruvo Center for Brain Health (142)
Las Vegas, Nevada, United States
Albany Medical College (139)
Albany, New York, United States
Ucgni (133)
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center (123)
Cleveland, Ohio, United States
Cleveland Clinic(144)
Cleveland, Ohio, United States
University of Toledo, Gardner-McMaster Parkinson Center (122)
Toledo, Ohio, United States
The Movement Disorder Clinic of Oklahoma (115)
Tulsa, Oklahoma, United States
The Vanderbilt Clinic (158)
Nashville, Tennessee, United States
Neurology Consultants of Dallas, PA (108)
Dallas, Texas, United States
University of Texas Southwestern Medical Center (143)
Dallas, Texas, United States
Houston Methodist Neurological Institute/Movement Disorders Clinic (135)
Houston, Texas, United States
Inova Neurology- Fairfax (147)
Fairfax, Virginia, United States
VCU Health- Neuroscience Orthopaedic and Wellness Center(124)
Henrico, Virginia, United States
Booth Gardner Parkinson's Care Center (112)
Kirkland, Washington, United States
Inland Northwest Research (119)
Spokane, Washington, United States
Fakultni nemocnice u sv. Anny v Brne, I. neurologicka klinika (704)
Brno, , Czechia
NEUROHK. s.r.o. (701)
Choceň, , Czechia
Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice, Neurologicka klinika (702)
Pardubice, , Czechia
CLINTRIAL s.r.o. (703)
Prague, , Czechia
AXON Clinical. s.r.o. (700)
Prague, , Czechia
Neurologicka ordinace FORBELI s.r.o. (706)
Prague, , Czechia
CHU de Clermont-Ferrand-Hopital Gabriel Montpied (404)
Clermont-Ferrand, , France
CHU de Montpellier, Hopital Gui de Chauliac (405)
Montpellier, , France
Centre Hospitalier Universitaire de Nice (400)
Nice, , France
Centre d'lnvestigation Clinique 1436- CHU Purpan- Hopital Pierre Paul Riquet (403)
Toulouse, , France
Kliniken Beelitz GmbH, neurologisches Fachkrankenhaus fur Bewegungsstorungen/Parkinson (300)
Beelitz-Heilstätten, Beelitz, Germany
St. Josef-Hospital, Universitatsklinik fur Neurologie Klinisches Forschungszentrum fur Neurodegeneration (301)
Bochum, Gudrunstabe 56, Germany
Klinikum rechts der lsar der Technischen Universitat Munchen Klinik und Poliklinik fur Neurologie (303)
München, Ismaningerstrabe, Germany
Dr. med. Reinhardt Ehret Neuroloqie Berlin Schlobstr. 29 (309)
Berlin, , Germany
Klinik Haag i. OB Geriatric Hospital Krankenhausstrabe 4 (305)
Haag in Oberbayern, , Germany
Gemeinschaftspraxis Dr. med. J. Springub/W. Schwarz, Studienzentrum Nordwest (306)
Westerstede, , Germany
Centro Ricerca Parkinson San Raffaele Cassino (601)
Cassino, Frosinone, Italy
Università G. D'annunzio CeSi Met (604)
Chieti, Italy/Chieti/Abbruzzo, Italy
Fondazione I st ituto Neurologico Nazionale "C. Mondino" (606)
Pavia, Italy/Pavia/Lombardia, Italy
Azienda Ospedaliero-Universitaria Pisana (602)
Pisa, Italy/Pisa/Toscana, Italy
IRCCS San Raffaele Pi sana (600)
Roma, Italy/Roma/Lazio, Italy
Department of neuroscience, mental health and sensory system (NeSMOS), "Sapienza" University (603)
Roma, Italy/Roma/Lazio, Italy
University of Rome Tor Vergata/Hospital Tor Vergata (605)
Rome, Lazio, Italy
Department "G. F. Ingrassia" section of neuroscience - Policlinico "Vittorio Emanuele" (608)
Catania, Sicily, Italy
Centrum Medyczne Neuromed (803)
Bydgoszcz, , Poland
Centrum Medyczne Linden (805)
Krakow, , Poland
Krakowska Akademia Neurologii Sp. Zo.o.(802)
Krakow, , Poland
NZOZ Neuromed M. i M. Nastaj Sp.p. (800)
Lublin, , Poland
NZOZ Neuro-Kard Ilkowski i Partnerzy Spolka Partnerska Lekarzy (801)
Poznan, , Poland
Neuro-Care Sp. z o.o. sp. k. (804)
Siemianowice Śląskie, , Poland
Centrum Medycme NeuroProtect (806)
Warsaw, , Poland
Hospital General Universitario de Elche (509)
Elche, Alicante, Spain
Hospital Universitari General de Catalunya (504)
Sant Cugat del Vallès, Barcelona, Spain
Hospital Universitari Mutua Terrassa (506)
Terrassa, Barcelona, Spain
Policlinica Gipuzkoa, S.A (511)
Donostia / San Sebastian, Gipuzkoa, Spain
Clinica Universidad de Navarra (512)
Pamplona, Navarre, Spain
Hospital Universitario Quiron Dexeus (501)
Barcelona, , Spain
Germanes Hospitalaries Del Sagrat Cor De Jesus Hospital Sant Rafael (516)
Barcelona, , Spain
Hospital Universitario Vall d'Hebron (505)
Barcelona, , Spain
Hospital de Ia Santa Creu i Sant Pau (502)
Barcelona, , Spain
Hospital Universitario de Ia Princesa (508)
Madrid, , Spain
Hospital Universitario Ramon y Cajal (500)
Madrid, , Spain
Hospital Universitario Infanta Sofia(513)
Madrid, , Spain
Hospital Universitario Virgen del Rocio (503)
Seville, , Spain
Hospital Universitario y Politecnico La Fe Avenida Fernando Abril Martorell (515)
Valencia, , Spain
Re:Cognition Health Ltd (205)
Plymouth, Devon, United Kingdom
Imperial College Healthcare NI-lS Trust (200)
London, , United Kingdom
Re:Cognition Health Ltd (202)
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-002234-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IPX203-B16-03
Identifier Type: -
Identifier Source: org_study_id
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