Trerief Impact in PD PET Study
- Conditions
- Parkinson's diseaseD010300
- Registration Number
- JPRN-jRCTs041180070
- Lead Sponsor
- Ouchi Yasuomi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion criteria are following
1) Early Parkinson's disease patients medicated once with levodopa/DCI and other anti-parkinsonian drugs excluding zonisamide
2) Patients under 80 years old
3) Patients who have voluntarily provided written informed consent to participate in the study
Exclusion criteria are following
1) Patients with parkinsonism except Parkinson's disease
2) Patients with epilepsy
3) Patients with a history of surgery for Parkinson's disease within 6 months before screening
4) Patients treated with zonisamide, selegiline and/or pramipexole within 3 months before screening
5) Patients with any severe psychiatric symptoms, such as confusion, hallucination, delusion and abnormal behaviors
6) Patients with any histories of malignant syndrome
7) Patients with a history of drug allergy for zonisamide
8) Patients participating any other clinical studies (intervention) when screening
9,10) Patients evaluated as unsuitable for participation in the study by physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Binding potential of the following PET ligands<br>1) 11C-CFT (binds to dopamine transporter)<br>2) 11C-DPA713 (binds to translocator protein in activated microglia)
- Secondary Outcome Measures
Name Time Method 1) Efficacy<br> Changes in<br> - scores of modified Hoehn-Yahr severity<br> - total scores of UPDRS part I, II and III<br> - subscores of UPDRS<br> - total and specific scores of PDQ-39<br> - total and specific scores of NPI<br> Duration from study start until any therapeutic changes (addition, dosage, administration of any anti-parkinsonian drugs)<br>2) Safety<br> Adverse events<br> Clinical tests/Vital sign/Body weight<br>3) Pharmacokinetics<br> Plasma zonisamide concentration