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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT03670953

Public ClinicalTrials.gov record NCT03670953. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 6:17 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03670953
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Impax Laboratories, LLC
Industry
Enrollment
630 participants

Conditions and interventions

Eligibility (public fields only)

Age range
40 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 6, 2018 (Actual)
Primary completion
Jun 15, 2021 (Actual)
Completion
Jun 15, 2021 (Actual)
Last update posted
Feb 9, 2023

2018 – 2021

United States locations

U.S. sites
56
U.S. states
23
U.S. cities
49
Facility City State ZIP Site status
Xenoscience, Inc. (102) Phoenix Arizona 85004 —
St. Joseph's Hospital & Medical Center/ Barrow Neurological Institute (156) Phoenix Arizona 85013 —
Clinical Trials, Inc. (113) Little Rock Arkansas 72205 —
University of Arkansas for Medical Sciences (117) Little Rock Arkansas 72205 —
Loma Linda University Health Care, Department of Neurology (137) Loma Linda California 92354 —
Keck School of Medicine of USC/University of Southern California (106) Los Angeles California 90033 —
Hoag Memorial Hospital Presbyterian (134) Newport Beach California 92663 —
SC3 Research - Pasadena (148) Pasadena California 91105 —
SC3 Research - Reseda (146) Reseda California 91335 —
University of Colorado Hospital Anschutz Outpatient Pavilion (120) Aurora Colorado 80045 —
Rocky Mountain Movement Disorders Center (116) Englewood Colorado 80113 —
Christiana Care Neurology Specialists (153) Newark Delaware 19713 —
JEM Research Institute (136) Atlantis Florida 33462 —
Visionary Investigators Network (168) Aventura Florida 33180 —
University of Miami-UHealth at Boca Raton (152) Boca Raton Florida 33131 —
Parkinson's Disease and Movement Disorders Center of Boca Raton (121) Boca Raton Florida 33486 —
MD Clinical (111) Hallandale Florida 33009 —
Infinity Clinical Research (104) Hollywood Florida 33024 —
University of Florida Health Science Center(129) Jacksonville Florida 32209 —
Neurology Associates, P.A. (125) Maitland Florida 32751 —
University of Miami (149) Miami Florida 33136 —
Medical Professional Clinical Research Center, INC (163) Miami Florida 33165 —
Parkinsons's Disease Treatment Center of Southwest Florida (131) Port Charlotte Florida 33980 —
Infinity Clinical Research, LLC (105) Sunrise Florida 33351 —
University of South Florida (114) Tampa Florida 33613 —
Premiere Research Institute at Palm Beach Neurology (174) West Palm Beach Florida 33407 —
Charter Research (166) Winter Park Florida 32792 —
Emory Brain Health Center (110) Atlanta Georgia 30329 —
NeuroStudies.net, LLC (155) Decatur Georgia 30033 —
Northwestern Medical Group Neurology Clinic(145) Chicago Illinois 60611 —
Central DuPage Hospital (151) Winfield Illinois 60190 —
Indiana University Health Neuroscience Center (164) Indianapolis Indiana 46202 —
University of Kansas Medical Center (118) Kansas City Kansas 66160 —
Quest Research Institute (103) Farmington Hills Michigan 48334 —
Henry Ford West Bloomfield Hospital (100) West Bloomfield Michigan 483222 —
Struthers Parkinson's Center (130) Golden Valley Minnesota 55427 —
Washington University (109) St Louis Missouri 63110 —
Cleveland Clinic Lou Ruvo Center for Brain Health (142) Las Vegas Nevada 89106 —
Roseman Medical Research Institute/Roseman Medical Group (154) Las Vegas Nevada 89118 —
Albany Medical College (139) Albany New York 12208 —
Mount Sinai West-Department of Neurology(172) New York New York 10019 —
Wake Forest Baptist Health Sciences (127) Winston-Salem North Carolina 27157 —
Ucgni (133) Cincinnati Ohio 45219 —
University Hospitals Cleveland Medical Center (123) Cleveland Ohio 44106 —
Cleveland Clinic (144) Cleveland Ohio 44195 —
University of Toledo, Gardner-McMaster Parkinson Center (122) Toledo Ohio 43614 —
Movement Disorder Clinic of Oklahoma (115) Tulsa Oklahoma 74136 —
Medical University of South Carolina (150) Charleston South Carolina 29425 —
The Vanderbilt Clinic(158) Nashville Tennessee 37232 —
Neurology Consultants of Dallas, PA (108) Dallas Texas 75251 —
University of Texas Southwestern Medical Center (143) Dallas Texas 75390-9184 —
Houston Methodist Neurological Institute/Movement Disorders Clinic (135) Houston Texas 77030 —
Inova Medical Group-Neurology I (147) Alexandria Virginia 22311 —
VCU Health - Neuroscience, Orthopaedic and Wellness Center (124) Henrico Virginia 23233 —
Booth Gardner Parkinson's Care Center (112) Kirkland Washington 98034 —
Inland Northwest Research (119) Spokane Washington 99202 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 52 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03670953, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 9, 2023 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03670953 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →