Phase 4 Open-Label Study of CREXONT Carbidopa and Levodopa Extended-Release Capsules for Treating Parkinsons Disease

What this Trial Is About

Researchers are evaluating the effectiveness and safety of CREXONT, an extended-release capsule containing Carbidopa and Levodopa, in people with Parkinson disease PD under real-world conditions. This Phase 4 study aims to understand how well CREXONT works in reducing motor symptom fluctuations in participants who are already treated with stable oral Carbidopa-Levodopa regimens. Participants will receive CREXONT extended-release capsules orally, with doses guided by FDA-approved prescribing information. The capsules come in several strengths, and dosing will be adjusted individually to find the best balance between effectiveness and tolerability. The study includes an initial dosing based on prior oral medication and allows optimization throughout the study to meet each participants needs. During the study, participants will complete Parkinsons Disease diaries to track On and Off motor states, and researchers will measure changes in Good On time and Off time by Day 42 compared to baseline. Participants will attend study visits and may receive questionnaires and assessments to monitor their condition and treatment response. The study is open-label, meaning all participants receive CREXONT, and the total participation duration includes baseline and follow-up assessments through Day 42.

A Study of CREXONT (Carbidopa and Levodopa) Extended-Release Capsules in Participants With Parkinson's Disease