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A Study of CREXONT for Parkinson's Disease

This study is looking at a new extended-release capsule called CREXONT (Carbidopa and Levodopa) for people with Parkinson's disease (PD). The main goal is to see how well CREXONT works and if it's safe to use in real-world situations. Researchers will measure how much time participants spend in a "GOOD ON" state, meaning their Parkinson's symptoms are well-controlled, using a daily diary over 42 days. You might be able to join if you have Parkinson's disease, are currently taking Carbidopa and Levodopa, and meet certain symptom criteria. The study aims to enroll 220 participants.

Study design
This is an interventional study with a planned enrollment of 220 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Day 42, indicating a follow-up period of at least 42 days.

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NCT06765668

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

Recruiting
PHASE4Ages 18+InterventionalTreatment
Impax Laboratories, LLC
~220 participants
Updated 2025-08-24 on ClinicalTrials.gov
What's tested:CREXONT ER

At a glance

Recruiting sites
23 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change From Baseline in "GOOD ON" time per the Parkinson's Disease Diary to Day 42
Measured over Baseline, Day 42

Conditions

Parkinson Disease

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NCT06765668

Where you'd take part

This study runs at 27 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Atrium Health Wake Forest Baptist Adult Neurology - Janeway Tower

    Winston-Salem, North Carolinastudy coordinator listed

    Recruiting

  • Barrow Neurological Institute

    Phoenix, Arizonastudy coordinator listed

    Not yet recruiting

  • Central DuPage Hospital - Movement Disorders Center

    Winfield, Illinoisstudy coordinator listed

    Not yet recruiting

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevadastudy coordinator listed

    Not yet recruiting

  • Icahn School of Medicine at Mount Sinai

    Houston, Texasstudy coordinator listed

    Not yet recruiting

  • Inova Neurology

    Fairfax, Virginiastudy coordinator listed

    Recruiting

  • MedStar Georgetown University Hospital Department of Neurology

    McLean, Virginiastudy coordinator listed

    Recruiting

  • N1 Research LLC

    Orlando, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Hester Visser, MD · STUDY_DIRECTOR · Amneal Pharmaceuticals, LLC

Who to contact

Rohit Dhall
[email protected]
501-526-5282
Email the study team

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Eligibility criteria

Inclusion

Require a total daily dose of at least 300 mg of LD and a maximum total daily dose of less than equal to \[\<=\]1200 mg LD (from IR CD-LD alone or from IR CD-LD in combination with a single daily bedtime dose of CR CD-LD).
The maximum individual dose allowed is 250 mg of LD.
The minimum individual dose should be at least 100 mg of LD. iii. For participants using a catechol-O-methyltransferase (COMT) inhibitor:
Require a total daily dose of at least 300 mg of LD and a maximum total daily dose of less than \[\<\]1000 mg LD.
The maximum individual dose is 200 mg of LD. iv. For participants using Rytary:
Require a total daily dose of at least 585 mg of LD and a maximum total daily dose of \<2100 mg LD.
The maximum individual dose is 685 mg of LD. b. Dose Frequency Requirement: i. If a participant is using IR/CR CD-LD alone or in combination with a COMT inhibitor, then the dosing frequency must be 3 to 6 times daily. ii. If a participant is using Rytary, then the dosing frequency must be 3 to 4 times daily. 8. Participant is able and willing to provide written informed consent prior to the conduct of any study-specific procedures. 9. Participant is able and willing to comply with the protocol, including completion of PD diaries, questionnaires, and available for all study visits and telephone calls. 10. Participants who have participated in prior CREXONT clinical studies are allowed to be enrolled in this Phase 4 study.

What this trial measures

  • Change From Baseline in "GOOD ON" time per the Parkinson's Disease Diary to Day 42Baseline, Day 42

    "GOOD ON" time is derived from the 3-day Parkinson's disease (PD) diaries. For each day, "GOOD ON" time is calculated by adding the number of half-hour intervals in which either an "on time without dyskinesia" or "on time with non-troublesome dyskinesia" is checked.