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

PHASE3CompletedINTERVENTIONAL
Enrollment

630

Participants

Timeline

Start Date

November 6, 2018

Primary Completion Date

June 15, 2021

Study Completion Date

June 15, 2021

Conditions
Parkinson's Disease (Disorder)
Interventions
DRUG

IR CD-LD

Active comparator - IR CD-LD

DRUG

IPX203 ER CD-LD

Investigational formulation - ER CD-LD

OTHER

Placebo Matching IPX203

Double dummy placebo capsules

OTHER

Placebo Matching IR CD-LD

Double dummy placebo tablets

Trial Locations (108)

10000

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

10019

Mount Sinai West-Department of Neurology(172), New York

12163

Dr. med. REINHARDT Ehret Neurologie 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

19713

Christiana Care Neurology Specialists (153), Newark

20014

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

22311

Inova Medical Group-Neurology I (147), Alexandria

23233

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

26655

Gemeinschaftspraxis Dr. med. Joachim Springub/ Wolfgang Schwarz, Studienzentrum Nord-West (306), Westerstede

27100

"Fondazione lstituto Neurologico Nazionale C. Mondino (606)", Pavia

27157

Wake Forest Baptist Health Sciences (127), Winston-Salem

28006

Hospital Universitario de la Princesa (508), Madrid

28034

Hospital Universitario Ramon y Cajal (500), Madrid

28703

Hospital Universitario Infanta Sofia (513), Madrid

29425

Medical University of South Carolina (150), Charleston

30033

NeuroStudies.net, LLC (155), Decatur

30329

Emory Brain Health Center (110), Atlanta

31008

Clinica Universidad de Navarra (512), Pamplona

31059

Centre d'Investigation 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

33009

MD Clinical (111), Hallandale

33024

Infinity Clinical Research (104), Hollywood

33131

University of Miami-UHealth at Boca Raton (152), Boca Raton

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

33462

JEM Research Institute (136), Atlantis

33486

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

33613

University of South Florida (114), Tampa

33980

Parkinsons'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

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 (515), Valencia

46202

Indiana University Health Neuroscience Center (164), Indianapolis

48334

Quest Research Institute (103), Farmington Hills

53203

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

55427

Struthers Parkinson's Center (130), Golden Valley

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

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

Universita 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

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 Center (116), Englewood

80331

Curiositas ad sanum, Studien und Beratungs GmbH(311), München

81675

Klinikum rechts der lsar der TUM, Klinik und Poliklinik fur Neurologie (303), München

83527

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

85004

Xenoscience, Inc. (102), Phoenix

85013

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

86021

INSERM, Centre d'investigation Clinique 1402, CHU de Poitiers (402), Poitiers

89106

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

89118

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

90033

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

91105

SC3 Research - Pasadena (148), Pasadena

91335

SC3 Research - Reseda (146), Reseda

92354

Loma Linda University Health Care, Department of Neurology (137), Loma Linda

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

483222

Henry Ford West Bloomfield Hospital (100), West Bloomfield

75390-9184

University of Texas Southwestern Medical Center (143), Dallas

160 00

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

06002

Centre Hospitalier Universitaire de Nice (400), Nice

01307

Universitatsklinikum Carl Gustav Carus, Klinik und Poliklinik fur Neurologie (307), Dresden

03043

Centro Ricerca Parkinson San Raffaele Cassino (601), Cassino

00133

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

00163

IRCCS San Raffaele Pisana (600), Roma

00189

Department of Neuroscience, Mental Health and Sensory System (NeSMOS), Sapienza University (603), Roma

85-163

Centrum Medyczne Neuromed (803), Bydgoszcz

30-394

Szpital Sw. Rozy (805), Krakow

31-505

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

20-064

NZOZ Neuromed M. i M Nastaj Spolka Partnerska(800), Lublin

61-853

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

41-100

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

01-684

Centrum Medyczne NeuroProtect (806), Warsaw

03203

Hospital Genral Universitario de Elche (509), Elche

08190

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

Hospital Universitario Vall d' Hebron (505), Barcelona

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

08036

Hospital Clinic de Barcelona (507), Barcelona

08041

Hospital De La Santa Creu i Sant Pau (502), Barcelona

PL68BT

Re: Cognition Health Ltd(205), Plymouth

W1G9JF

Re:Cognition Health Ltd (202), London

W68RF

Imperial College Healthcare NHS Trust (200), London

Sponsors
All Listed Sponsors
lead

Impax Laboratories, LLC

INDUSTRY

NCT03670953 - A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations | Biotech Hunter | Biotech Hunter