Levodopa/carbidopa for Parkinson's (NCT06785298)
Test fexofenadine for motor improvement
- Trial ID
- NCT06785298
- Official Title
- Clinical Study to Evaluate the Possible Efficacy and Safety of Fexofenadine in Patients With Parkinson's Disease Treated With Conventional Treatment
- Goal
- Test fexofenadine for motor improvement
- Phase
- PHASE2, PHASE3
- Status
- RECRUITING
- Sponsor
- Tanta University
- Study Type
- INTERVENTIONAL
- Enrollment
- 46 participants
- Conditions
- Parkinson Disease
- Interventions
- Levodopa/carbidopa, Fexofenadine
Summary For Families
The goal is to see whether adding fexofenadine to standard levodopa/carbidopa can safely improve Parkinson's symptoms or the overall response to dopamine replacement, while checking for side effects. Fexofenadine is an oral, non-sedating H1 antihistamine that blocks peripheral histamine receptors and has minimal brain penetration, so the trial is testing whether blocking histamine signaling outside the brain changes motor or non-motor symptoms, affects levodopa-related effects, or reduces inflammation without causing sedation or drug interactions. They're enrolling men and women age 50 to 70 with Parkinson's at Hoehn and Yahr stages 1 to 4 who are already on dopamine replacement, excluding people with atypical parkinsonism, significant liver, kidney, or heart problems, pregnancy or breastfeeding, substance abuse, or known allergy to the medications.
Locations
- Tanta University, Tanta, Egypt
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Levodopa/carbidopa. The goal is to see whether adding fexofenadine to standard levodopa/carbidopa can safely improve Parkinson's symptoms or the overall response to dopamine replacement, while checking for side effects. Fexofenadine is an oral, non-sedating H1 antihistamine that blocks peripheral histamine receptors and has minimal brain penetration, so the trial is testing whether blocking histamine signaling outside the brain changes motor or non-motor symptoms, affects levodopa-related effects, or reduces inflammation without causing sedation or drug interactions. They're enrolling men and women age 50 to 70 with Parkinson's at Hoehn and Yahr stages 1 to 4 who are already on dopamine replacement, excluding people with atypical parkinsonism, significant liver, kidney, or heart problems, pregnancy or breastfeeding, substance abuse, or known allergy to the medications.
- Who can participate?
- Participants must be between 50 Years and 70 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 2/Phase 3 trial is estimated to last approximately 2 years.
- 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?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.