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

NCT03670953 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 630

Last updated 2023-02-09

Study results available
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Summary

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.

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

Sponsors & Collaborators

  • Impax Laboratories, LLC

    lead INDUSTRY

Principal Investigators

  • Impax Study Director · Impax Laboratories, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-06
Primary Completion
2021-06-15
Completion
2021-06-15
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • France
  • Germany
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03670953 on ClinicalTrials.gov