levodopa/carbidopa oral formulatio… for Parkinson's (NCT05471609)
Reduce on off motor swings
- Trial ID
- NCT05471609
- Official Title
- Sustained Release Oral Formulation for Treatment of Parkinson's Disease
- Goal
- Reduce on off motor swings
- Phase
- EARLY_PHASE1
- Status
- COMPLETED
- Sponsor
- University of Minnesota
- Study Type
- INTERVENTIONAL
- Enrollment
- 6 participants
- Conditions
- Healthy Volunteers
- Interventions
- levodopa/carbidopa oral formulation A, levodopa/carbidopa oral formulation B
Summary For Families
Goal: test whether sustained-release oral levodopa/carbidopa can keep levodopa levels more steady, which could help reduce the on/off motor swings people with Parkinson's get with standard levodopa dosing. Approach: two experimental sustained-release formulations, A and B, are being given to healthy volunteers to look at safety and how the body absorbs and clears the drug; the pills release levodopa more slowly and include carbidopa to prevent early breakdown so more levodopa reaches the brain. Eligibility: healthy adults 18 to 65 who are not on regular medications, can fast for six hours, and are not pregnant.
Locations
- University of Minnesota, Minneapolis, Minnesota, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying levodopa/carbidopa oral formulation A. Goal: test whether sustained-release oral levodopa/carbidopa can keep levodopa levels more steady, which could help reduce the on/off motor swings people with Parkinson's get with standard levodopa dosing. Approach: two experimental sustained-release formulations, A and B, are being given to healthy volunteers to look at safety and how the body absorbs and clears the drug; the pills release levodopa more slowly and include carbidopa to prevent early breakdown so more levodopa reaches the brain. Eligibility: healthy adults 18 to 65 who are not on regular medications, can fast for six hours, and are not pregnant.
- Who can participate?
- Participants must be between 18 Years and 65 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- 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 1 trial is estimated to last approximately 2 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.