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Completed · registry status

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

A plain-language introduction is being prepared for this study. Open it to read the original description, who can join and how to contact the team.

Testing a treatment or activity · Study reference: NCT03670953

The registry title is shown while an English plain-language introduction is prepared. Read the original details below ↓

This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

Open the official registry record ↗

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Results reported

Start (reported actual date)
2018-11-06
Main measurements finished (reported actual date)
2021-06-15
Study finished (reported actual date)
2021-06-15

Planned dates can move. A study finishing does not tell us when a paper will be published.

Read the results reported in the registry ↗

Changes we have recorded
  • 2026-10-11 — completed

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

IPX203 vs Immediate-Release Carbidopa-Levodopa for the Treatment of Motor Fluctuations in Parkinson Disease
This paper mentions the study ID; the relationship needs review · 2023

Hauser RA, Espay AJ, Ellenbogen AL, Fernandez HH, Isaacson SH, LeWitt PA, Ondo WG, Pahwa R, Schwarz J, Stocchi F, Zeitlin L, Banisadr G, Fisher S, Visser H, D'Souza R. IPX203 vs Immediate-Release Carbidopa-Levodopa for the Treatment of Motor Fluctuations in Parkinson Disease: The RISE-PD Randomized Clinical Trial. JAMA Neurol. 2023 Oct 1;80(10):1062-1069. doi: 10.1001/jamaneurol.2023.2679. ↗
Registry derived research reference

Participation rules recorded for this study

Age 40 years and over · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

Inclusion Criteria: * Male or female participants diagnosed at age ≥ 40 years with PD, consistent with the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria and who are being treated with stable regimens of CD-LD but experiencing motor fluctuations. * 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 Screening Visit. * Negative urine screen for drugs of abuse and negative alcohol breath test at Screening. * Hoehn and Yahr Stages 1, 2, 3, or 4 in the "On" state (part of Movement Disorders Society version of the Unified Parkinson's Disease Rating Scale \[MDS-UPDRS\] Part III) * Agrees to use a medically acceptable method of contraception throughout the study and for 6 weeks after completing the study. Medically acceptable methods of contraception that may be used by the participant and/or partner include but are not limited to: abstinence, oral contraception, NuvaRing or transdermal systems, diaphragm with vaginal spermicide, intrauterine device, condom and partner using vaginal spermicide, surgical sterilization (6 months), progestin implant or injection, or postmenopausal female (no menstrual period for ˃ 2 years) or vasectomy (˃ 6 months). * Montreal Cognitive Assessment (MoCA) score ≥ 24 at Screening Visit in "On" state. * Able to differentiate "On" state from "Off" state as determined by at least 75% concordance with a trained rater in "On/Off" ratings for 8 ratings over a 4-hour training period. The concordance must include at least 1 "On" and 1 "Off" rating and must be achieved within two 4-hour training sessions. * Able and willing to comply with the protocol, including completion of diaries and availability for all study visits. * Responsive to CD-LD therapy and currently being treated on a stable regimen with CD-LD for at least 4 weeks prior to Visit 1. * At Screening, the participant has predictable "Off" periods. Exclusion Criteria: * Received any investigational medications within 30 days or 5 times the half-life, whichever is longer, prior to Visit 1. * Female participants who are currently breastfeeding or lactating. * Had prior neurosurgical treatment for PD or if such procedure is planned or anticipated during the study period. * Allergic to any excipient in the study drugs. * History of medical conditions or of a prior surgical procedure that would interfere with LD absorption, such as gastrectomy, proximal small-bowel resection, or bariatric surgery. * History of upper gastrointestinal hemorrhage in participants with peptic ulcer disease within the past 5 years. * History of glaucoma with intraocular pressures that are elevated despite appropriate medical management. * History of seizure or epilepsy and experienced at least 1 seizure during the past 12 months or has not been compliant with medically recommended therapy or visits. * History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias that are not controlled with medical and/or surgical interventions. A recent (≤ 12 months) history of myocardial infarction with secondary arrhythmias is exclusionary regardless of the therapeutic control. * History of neuroleptic malignant syndrome or of nontraumatic rhabdomyolysis. * Liver enzyme values ≥ 2.5 times the upper limit of normal; or history of severe hepatic impairment. * Serum creatinine level ≥ 1.75 times the upper limit of normal; or requires dialysis at the time of Screening. * Participant with a history of malignant melanoma or with a suspicious undiagnosed skin lesion which in the opinion of the investigator could be melanoma. * History of drug or alcohol abuse within the 12 months prior to Screening. * Received within 4 weeks of Screening or planning to take during participation in the clinical study: * Any doses of a CR CD-LD apart from a single daily bedtime dose, any doses of Rytary, additional CD (eg, Lodosyn) or benserazide (eg, Serazide), or catechol-O-methyl transferase inhibitors (entacapone or tolcapone) or medications containing these inhibitors (Stalevo), * Nonselective monoamine oxidase inhibitors (MAOI), apomorphine, or antidopaminergic agents, including antiemetics. * Employees or family members of the investigator, study site, or sponsor. * Participants who have previously participated in an IPX203 study. * Participants who, in the opinion of the clinical investigator, should not participate in the study. * Based on clinical assessment, participant does not adequately comprehend the terminology needed to complete the PD diary.
Full study name & original research details

Official study title

A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor Fluctuations

Short title used by the registry

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

Original description

To evaluate the safety and efficacy of IPX203 (carbidopa and levodopa) extended-release capsules (IPX203 ER CD-LD) in comparison to immediate release (IR) CD-LD in the treatment of CD-LD-experienced participants with Parkinson's disease (PD) who have motor fluctuations.

Further description from the registry

This was a multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group study. The study consisted of a 3-week, open-label IR CD-LD dose adjustment period; a 4-week, open-label period for conversion to IPX203; followed by a 13-week double-blind treatment period with participants randomized in a 1:1 ratio, stratified by center, to receive either IPX203 (with matching IR CD-LD placebo) or IR CD-LD (with matching IPX203 placebo).

Conditions reported: Parkinson's Disease (Disorder)

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
IR CD-LD; IPX203 ER CD-LD; Placebo Matching IPX203; Placebo Matching IR CD-LD
Phases
PHASE3
Sponsor
Impax Laboratories, LLC
Start date reported by registry
2018-11-06 (actual)

Registry updated: 2023-02-09 · Status last verified by the registry submitter: 2022-09

Registry records retrieved 2026-10-12 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

No central contact is listed. Check the location contacts or the official registry record.

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Xenoscience, Inc. (102)

Phoenix, Arizona, United States

Status not reported

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

Phoenix, Arizona, United States

Status not reported

Clinical Trials, Inc. (113)

Little Rock, Arkansas, United States

Status not reported

University of Arkansas for Medical Sciences (117)

Little Rock, Arkansas, United States

Status not reported

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

Loma Linda, California, United States

Status not reported

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

Los Angeles, California, United States

Status not reported

Hoag Memorial Hospital Presbyterian (134)

Newport Beach, California, United States

Status not reported

SC3 Research - Pasadena (148)

Pasadena, California, United States

Status not reported

SC3 Research - Reseda (146)

Reseda, California, United States

Status not reported

University of Colorado Hospital Anschutz Outpatient Pavilion (120)

Aurora, Colorado, United States

Status not reported

Rocky Mountain Movement Disorders Center (116)

Englewood, Colorado, United States

Status not reported

Christiana Care Neurology Specialists (153)

Newark, Delaware, United States

Status not reported

JEM Research Institute (136)

Atlantis, Florida, United States

Status not reported

Visionary Investigators Network (168)

Aventura, Florida, United States

Status not reported

University of Miami-UHealth at Boca Raton (152)

Boca Raton, Florida, United States

Status not reported

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

Boca Raton, Florida, United States

Status not reported

MD Clinical (111)

Hallandale, Florida, United States

Status not reported

Infinity Clinical Research (104)

Hollywood, Florida, United States

Status not reported

University of Florida Health Science Center(129)

Jacksonville, Florida, United States

Status not reported

Neurology Associates, P.A. (125)

Maitland, Florida, United States

Status not reported

University of Miami (149)

Miami, Florida, United States

Status not reported

Medical Professional Clinical Research Center, INC (163)

Miami, Florida, United States

Status not reported

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

Port Charlotte, Florida, United States

Status not reported

Infinity Clinical Research, LLC (105)

Sunrise, Florida, United States

Status not reported

University of South Florida (114)

Tampa, Florida, United States

Status not reported

Premiere Research Institute at Palm Beach Neurology (174)

West Palm Beach, Florida, United States

Status not reported

Charter Research (166)

Winter Park, Florida, United States

Status not reported

Emory Brain Health Center (110)

Atlanta, Georgia, United States

Status not reported

NeuroStudies.net, LLC (155)

Decatur, Georgia, United States

Status not reported

Northwestern Medical Group Neurology Clinic(145)

Chicago, Illinois, United States

Status not reported

Central DuPage Hospital (151)

Winfield, Illinois, United States

Status not reported

Indiana University Health Neuroscience Center (164)

Indianapolis, Indiana, United States

Status not reported

University of Kansas Medical Center (118)

Kansas City, Kansas, United States

Status not reported

Quest Research Institute (103)

Farmington Hills, Michigan, United States

Status not reported

Henry Ford West Bloomfield Hospital (100)

West Bloomfield, Michigan, United States

Status not reported

Struthers Parkinson's Center (130)

Golden Valley, Minnesota, United States

Status not reported

Washington University (109)

St Louis, Missouri, United States

Status not reported

Cleveland Clinic Lou Ruvo Center for Brain Health (142)

Las Vegas, Nevada, United States

Status not reported

Roseman Medical Research Institute/Roseman Medical Group (154)

Las Vegas, Nevada, United States

Status not reported

Albany Medical College (139)

Albany, New York, United States

Status not reported

Mount Sinai West-Department of Neurology(172)

New York, New York, United States

Status not reported

Wake Forest Baptist Health Sciences (127)

Winston-Salem, North Carolina, United States

Status not reported

Ucgni (133)

Cincinnati, Ohio, United States

Status not reported

University Hospitals Cleveland Medical Center (123)

Cleveland, Ohio, United States

Status not reported

Cleveland Clinic (144)

Cleveland, Ohio, United States

Status not reported

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

Toledo, Ohio, United States

Status not reported

Movement Disorder Clinic of Oklahoma (115)

Tulsa, Oklahoma, United States

Status not reported

Medical University of South Carolina (150)

Charleston, South Carolina, United States

Status not reported

The Vanderbilt Clinic(158)

Nashville, Tennessee, United States

Status not reported

Neurology Consultants of Dallas, PA (108)

Dallas, Texas, United States

Status not reported

University of Texas Southwestern Medical Center (143)

Dallas, Texas, United States

Status not reported

Houston Methodist Neurological Institute/Movement Disorders Clinic (135)

Houston, Texas, United States

Status not reported

Inova Medical Group-Neurology I (147)

Alexandria, Virginia, United States

Status not reported

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

Henrico, Virginia, United States

Status not reported

Booth Gardner Parkinson's Care Center (112)

Kirkland, Washington, United States

Status not reported

Inland Northwest Research (119)

Spokane, Washington, United States

Status not reported

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

Brno, Czechia

Status not reported

Neurohk, s.r.o (701)

Choceň, Czechia

Status not reported

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

Pardubice, Czechia

Status not reported

Clintrial s.r.o. (703)

Prague, Czechia

Status not reported

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

Prague, Czechia

Status not reported

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

Prague, Czechia

Status not reported

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

Clermont-Ferrand, France

Status not reported

CHU de Montpellier, Hopital Gui de Chauliac(405)

Montpellier, France

Status not reported

Centre Hospitalier Universitaire de Nice (400)

Nice, France

Status not reported

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

Poitiers, France

Status not reported

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

Toulouse, France

Status not reported

Curiositas ad sanum, Studien und Beratungs GmbH(311)

München, Bavaria, Germany

Status not reported

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

München, Bavaria, Germany

Status not reported

Kliniken Beelitz GmbH, Neurologisches Fachkrankenhaus fUr Bewegungsstorungen/Parkinson (300)

Beelitz-Heilstätten, Brandenburg, Germany

Status not reported

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

Westerstede, Lower Saxony, Germany

Status not reported

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

Bochum, North Rhine-Westphalia, Germany

Status not reported

Klinik Haag i. OB, Geriatric Hospital (305)

Haag in Oberbayern, Oberbayern (Upper Bavaria), Germany

Status not reported

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

Dresden, Saxony, Germany

Status not reported

Dr. med. REINHARDT Ehret Neurologie Berlin Schlobstr. 29 (309)

Berlin, Germany

Status not reported

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

Catania, Italy/Catania/Sicily, Italy

Status not reported

Universita G. D'annunzio CeSi Met (604)

Chieti, Italy/Chieti/Abbruzzo, Italy

Status not reported

Centro Ricerca Parkinson San Raffaele Cassino (601)

Cassino, Italy/Frosinone/Lazio, Italy

Status not reported

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

Pavia, Italy/Pavia/Lombardia, Italy

Status not reported

Azienda Ospedaliero-Universitaria Pisana (602)

Pisa, Italy/Pisa/Toscana, Italy

Status not reported

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

Roma, Italy/Roma/Lazio, Italy

Status not reported

IRCCS San Raffaele Pisana (600)

Roma, Italy/Roma/Lazio, Italy

Status not reported

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

Roma, Italy/Roma/Lazio, Italy

Status not reported

Centrum Medyczne Neuromed (803)

Bydgoszcz, Poland

Status not reported

Szpital Sw. Rozy (805)

Krakow, Poland

Status not reported

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

Krakow, Poland

Status not reported

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

Lublin, Poland

Status not reported

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

Poznan, Poland

Status not reported

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

Siemianowice Śląskie, Poland

Status not reported

Centrum Medyczne NeuroProtect (806)

Warsaw, Poland

Status not reported

Hospital Genral Universitario de Elche (509)

Elche, Alicante, Spain

Status not reported

Hospital Universitari General de Catalunya (504)

Sant Cugat del Vallès, Barcelona, Spain

Status not reported

Hospital Universitari Mutua Terrassa (506)

Terrassa, Barcelona, Spain

Status not reported

Policlinica Gipuzkoa, S.A.,(511)

Donostia / San Sebastian, Gipuzkoa, Spain

Status not reported

Clinica Universidad de Navarra (512)

Pamplona, Navarre, Spain

Status not reported

Hospital Universitario Quiron Dexeus (501)

Barcelona, Spain

Status not reported

Hospital Universitario Vall d' Hebron (505)

Barcelona, Spain

Status not reported

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

Barcelona, Spain

Status not reported

Hospital Clinic de Barcelona (507)

Barcelona, Spain

Status not reported

Hospital De La Santa Creu i Sant Pau (502)

Barcelona, Spain

Status not reported

Hospital Universitario de la Princesa (508)

Madrid, Spain

Status not reported

Hospital Universitario Ramon y Cajal (500)

Madrid, Spain

Status not reported

Hospital Universitario Infanta Sofia (513)

Madrid, Spain

Status not reported

Hospital Universitario Virgen del Rocio (503)

Seville, Spain

Status not reported

Hospital Universitario y politecnico La Fe (515)

Valencia, Spain

Status not reported

Re: Cognition Health Ltd(205)

Plymouth, Devon, United Kingdom

Status not reported

Re:Cognition Health Ltd (202)

London, United Kingdom

Status not reported

Imperial College Healthcare NHS Trust (200)

London, United Kingdom

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.