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

PHASE3CompletedINTERVENTIONAL
Enrollment

419

Participants

Timeline

Start Date

April 3, 2019

Primary Completion Date

March 21, 2022

Study Completion Date

March 21, 2022

Conditions
Parkinson Disease
Interventions
DRUG

IPX203

IPX203 extended release capsules

Trial Locations (98)

10000

CLINTRIAL s.r.o. (703), Prague

12163

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

12208

Albany Medical College (139), Albany

14547

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

15000

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

16000

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

17601

Roseman Medical Research Institute / Roseman Medical Group (154), Las Vegas

Inova Neurology- Fairfax (147), Fairfax

19713

ChristianaCare Neurology Specialists (153), Newark

20014

Policlinica Gipuzkoa, S.A (511), Donostia / San Sebastian

23233

VCU Health- Neuroscience Orthopaedic and Wellness Center(124), Henrico

26655

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

27100

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

28006

Hospital Universitario de Ia Princesa (508), Madrid

28034

Hospital Universitario Ramon y Cajal (500), Madrid

28703

Hospital Universitario Infanta Sofia(513), Madrid

30033

NeuroStudies.net, LLC (155), Decatur

30329

Emory Brain Health Center (110), Atlanta

30721

Centrum Medyczne Linden (805), Krakow

31008

Clinica Universidad de Navarra (512), Pamplona

31059

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

32209

University of Florida Health Science Center (129), Jacksonville

32751

Neurology Associates, P.A. (125), Maitland

32792

Charter Research (166), Winter Park

33024

Infinity Clinical Research LLC (104), Hollywood

33136

University of Miami (149), Miami

33165

Medical Professional Clinical Research Center, Inc. (163), Miami

33180

Visionary Investigators Network (168), Aventura

33351

Infinity Clinical Research, LLC (105), Sunrise

33407

Premiere Research Institute at Palm Beach Neurology (174), West Palm Beach

33431

UHealth at Boca Raton (152), Boca Raton

33462

JEM Research Institute (136), Atlantis

33486

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

33615

University of South Florida (114), Tampa

33980

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

34295

CHU de Montpellier, Hopital Gui de Chauliac (405), Montpellier

37232

The Vanderbilt Clinic (158), Nashville

41013

Hospital Universitario Virgen del Rocio (503), Seville

41100

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

43614

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

44106

University Hospitals Cleveland Medical Center (123), Cleveland

44195

Cleveland Clinic(144), Cleveland

44791

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

45219

Ucgni (133), Cincinnati

46026

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

46202

Indiana University Health Neuroscience Center(164), Indianapolis

48322

Henry Ford West Bloomfield Hospital(100), West Bloomfield

48334

Quest Research Institute (103), Farmington Hills

53203

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

56126

Azienda Ospedaliero-Universitaria Pisana (602), Pisa

56501

NEUROHK. s.r.o. (701), Choceň

60190

Central DuPage Hospital (151), Winfield

60611

Northwestern Medical Group Neurology Clinic (145), Chicago

61853

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

63003

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

63110

Washington University (109), St Louis

65691

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

66100

Università G. D'annunzio CeSi Met (604), Chieti

66160

University of Kansas Medical Center (118), Kansas City

72205

Clinical Trials, Inc (113), Little Rock

University of Arkansas for Medical Sciences (117), Little Rock

74136

The Movement Disorder Clinic of Oklahoma (115), Tulsa

75251

Neurology Consultants of Dallas, PA (108), Dallas

77030

Houston Methodist Neurological Institute/Movement Disorders Clinic (135), Houston

80045

University of Colorado Hospital Anschutz Outpatient Pavilion (120), Aurora

80113

Rocky Mountain Movement Disorders (116), Englewood

81675

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

83527

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

85004

Xenoscience, Inc (102), Phoenix

85013

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

85163

Centrum Medyczne Neuromed (803), Bydgoszcz

89106

Cleveland Clinic Lou Ruvo Center for Brain Health (142), Las Vegas

90033

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

91105

SC3 Research-Pasadena (148), Pasadena

91335

SC3 Research-Reseda (146), Reseda

92663

Hoag Memorial Hospital Presbyterian (134), Newport Beach

95123

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

98034

Booth Gardner Parkinson's Care Center (112), Kirkland

99202

Inland Northwest Research (119), Spokane

75390-9184

University of Texas Southwestern Medical Center (143), Dallas

06002

Centre Hospitalier Universitaire de Nice (400), Nice

03043

Centro Ricerca Parkinson San Raffaele Cassino (601), Cassino

00163

IRCCS San Raffaele Pi sana (600), Roma

00189

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

00133

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

31-505

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

20-064

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

01-684

Centrum Medycme NeuroProtect (806), Warsaw

03203

Hospital General Universitario de Elche (509), Elche

08195

Hospital Universitari General de Catalunya (504), Sant Cugat del Vallès

08222

Hospital Universitari Mutua Terrassa (506), Terrassa

08028

Hospital Universitario Quiron Dexeus (501), Barcelona

08035

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

Hospital Universitario Vall d'Hebron (505), Barcelona

08041

Hospital de Ia Santa Creu i Sant Pau (502), Barcelona

PL68BT

Re:Cognition Health Ltd (205), Plymouth

W68RF

Imperial College Healthcare NI-lS Trust (200), London

WlG9JF

Re:Cognition Health Ltd (202), London

Sponsors
All Listed Sponsors
lead

Impax Laboratories, LLC

INDUSTRY

NCT03877510 - Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations | Biotech Hunter | Biotech Hunter