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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 4 trial is estimated to last approximately 9 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.