CREXONT for Parkinson's Disease

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

Recruiting Phase 4 Interventional Study
Parkinson Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
220 (estimated)
Sponsor
Impax Laboratories, LLC · Industry
Who this trial is looking for

This trial is looking for participants with Parkinson's disease who have regular 'off' periods where symptoms worsen. Taking part involves evaluating the effects of a medication called CREXONT over a period of time.

Are You a Good Fit for This Trial?
Must be taking Carbidopa-levodopa
Must not be taking DuopaNonselective MAOIApomorphineInhaled levodopa

You may be able to join if

  • I have Parkinson's disease and follow a stable treatment.
  • I score at least 20 on the Movement Disorder Society rating scale in the 'Off' state.
  • I experience predictable 'off' periods during which my symptoms worsen.
  • I have daily 'wearing-off' episodes affecting my motor symptoms.
  • I recognize the difference between my 'On' and 'Off' states.
  • I can complete a 3-day diary of my symptoms with valid entries.
  • I have been on a stable regimen of oral carbidopa-levodopa for at least 4 weeks.
  • I can give written consent to participate in this study.

You may not be able to join if

  • I have had prior surgery for Parkinson's disease.
  • I have taken certain medications within the last 4 weeks.
  • I do not understand the study terms or procedures.
  • I am an employee or family member of the study staff.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

The primary purpose of this study is to evaluate efficacy and safety of CREXONT under real world conditions in participants with Parkinson disease (PD).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Participants with PD consistent with the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria and who are being treated with stable regimens of oral CD-LD. 2. Participants with a score of at least 20 units at Screening on the Movement Disorder Society - U…
Contacts

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