CREXONT ER for Parkinson's (NCT06765668)
Reduce predictable wearing off periods
- Trial ID
- NCT06765668
- Official Title
- Open-Label Phase 4 Study of CREXONT® (Carbidopa and Levodopa) Extended Release Capsules in Parkinson's Disease Patients
- Goal
- Reduce predictable wearing off periods
- Phase
- PHASE4
- Status
- RECRUITING
- Sponsor
- Impax Laboratories, LLC
- Study Type
- INTERVENTIONAL
- Enrollment
- 220 participants
- Conditions
- Parkinson Disease
- Interventions
- CREXONT ER
Summary For Families
The trial aims to see if an extended‑release carbidopa‑levodopa capsule can reduce predictable wearing-off and cut daily "Off" time for people with Parkinson's who still respond to levodopa. Participants will be switched to CREXONT ER, an extended‑release formulation that releases levodopa more slowly while carbidopa prevents peripheral breakdown, so more levodopa reaches the brain and dopamine levels stay steadier, which may smooth motor fluctuations and reduce how often you need doses. It's enrolling adults 18 and older with Parkinson's who have predictable Off periods and at least 2.5 hours of Off time per day, are on a stable oral carbidopa‑levodopa regimen for at least 4 weeks, can tell On from Off and complete diaries, with people who have had DBS or recent Duopa, apomorphine, or nonselective MAOI use excluded.
Locations
- Barrow Neurological Institute, Phoenix, Arizona, United States
- University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
- Parkinson's Research Centers of America - Orange County, Aliso Viejo, California, United States
- Parkinson's Research Centers of America - Palo Alto, Palo Alto, California, United States
- Visionary Investigators Network, Aventura, Florida, United States
- Parkinsons Disease and Movement Disorders Center of Boca Raton, Boca Raton, Florida, United States
- Univesity of Miami - Miller School of Medicine, Boca Raton, Florida, United States
- University of Miami, Miami, Florida, United States
- N1 Research LLC, Orlando, Florida, United States
- USF Parkinson's Disease and Movement Disorders Center, Tampa, Florida, United States
- Central DuPage Hospital - Movement Disorders Center, Winfield, Illinois, United States
- University of Kansas Medical Center, Kansas City, Kansas, United States
- Quest Research Institute, Farmington Hills, Michigan, United States
- Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, Nevada, United States
- Parkinson's Research Centers of America - Long Island, Commack, New York, United States
- Atrium Health Wake Forest Baptist Adult Neurology - Janeway Tower, Winston-Salem, North Carolina, United States
- NeuroScience Research Center, LLC, Canton, Ohio, United States
- University of Cincinnati, Cincinnati, Ohio, United States
- University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
- The Movement Disorder Clinic of Oklahoma, Tulsa, Oklahoma, United States
And 7 more locations.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying CREXONT ER. The trial aims to see if an extended‑release carbidopa‑levodopa capsule can reduce predictable wearing-off and cut daily "Off" time for people with Parkinson's who still respond to levodopa. Participants will be switched to CREXONT ER, an extended‑release formulation that releases levodopa more slowly while carbidopa prevents peripheral breakdown, so more levodopa reaches the brain and dopamine levels stay steadier, which may smooth motor fluctuations and reduce how often you need doses. It's enrolling adults 18 and older with Parkinson's who have predictable Off periods and at least 2.5 hours of Off time per day, are on a stable oral carbidopa‑levodopa regimen for at least 4 weeks, can tell On from Off and complete diaries, with people who have had DBS or recent Duopa, apomorphine, or nonselective MAOI use excluded.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 27 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 4 trial is estimated to last approximately 9 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.