CREXONT ER for Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of 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).
Will I have to stop taking my current medications?
The trial requires participants to be on a stable regimen of oral CD-LD (a medication for Parkinson's) for at least 4 weeks before starting. Some medications, like certain CR CD-LD doses, Duopa, nonselective MAOIs, and rescue medications for 'off' episodes, must be stopped at least 4 weeks before the trial begins.
Who Is on the Research Team?
Hester Visser, MD
Principal Investigator
Amneal Pharmaceuticals, LLC
Are You a Good Fit for This Trial?
This trial is for people with Parkinson's Disease who have stable treatment regimens of oral Carbidopa-Levodopa, can tell the difference between 'On' and 'Off' states, and experience at least 2.5 hours per day of 'Off' time. They must not have had neurosurgical treatments for PD or plan to before Day 42 of the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CREXONT extended release capsules, with dosing optimized based on FDA guidelines
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CREXONT
Find a Clinic Near You
Who Is Running the Clinical Trial?
Impax Laboratories, LLC
Lead Sponsor
Amneal Pharmaceuticals, LLC
Industry Sponsor