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?
- 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 2/Phase 3 trial is estimated to last approximately 2 years.
- 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.