Parkinson'
Conditions
Interventions
Zonisamide treatment group: Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allow
1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbatio
1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms.
Sponsors
Hamamatsu University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: Exclusion criteria are following; 1) Patients with parkinsonism except Parkinson's disease 2) Patients with epilepsy 3) Patients with a history of surgery for PD 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Yearly evaluation for the binding potential of the following PET ligands: 1) 11C-CFT (binds to dopamine transporter) 2) 11C-DPA713 (binds to translocator protein in activated microglia) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the following scores every 6 months; 1) Efficacy - Changes in a) scores of modified Hoehn-Yahr severity b) total scores of UPDRS part I, II and III c) subscores of UPDRS d) total and specific scores of PDQ-39 e) total and specific scores of NPI - Duration from study start until any therapeutic changes (addition, dosage, administration of any anti-parkinsonian drugs) 2) Safety - Adverse events - Clinical tests/Vital sign/Body weight 3) Pharmacokinetics - Plasma zonisamide concentration | — |
Countries
Japan
Contacts
Public ContactYasuomi OUCHI, MD, PhD.
Hamamatsu University School of Medicine Department of Biofuncional Imaging, Medical Photonics Research Center
Outcome results
None listed