A Study of CREXONT (Carbidopa and Levodopa) Extended-Release Capsules in Participants With Parkinson's Disease
NCT06765668 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220
Last updated 2025-08-24
Summary
The primary purpose of this study is to evaluate efficacy and safety of CREXONT under real world conditions in participants with Parkinson disease (PD).
Conditions
- Parkinson Disease
Interventions
- DRUG
-
CREXONT ER
CREXONT ER capsule.
Sponsors & Collaborators
-
Amneal Pharmaceuticals, LLC
collaborator INDUSTRY -
Impax Laboratories, LLC
lead INDUSTRY
Principal Investigators
-
Hester Visser, MD · Amneal Pharmaceuticals, LLC
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-12
- Primary Completion
- 2025-11-30
- Completion
- 2026-08-06
- FDA Drug
- Yes
Countries
- United States
Study Locations
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