A double-blind confirmatory study for AD-810N (zonisamide) in patients with Parkinson's disease (Phase III)
Phase 3
- Conditions
- Parkinson's disease
- Registration Number
- JPRN-jRCT2080221162
- Lead Sponsor
- Dainippon Sumitomo Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 360
Inclusion Criteria
Patients with Parkinson's disease who meet the following criteria
- Patients who are effective in the treatment of L-DOPA single-agent or L-DOPA/DCI combination of drugs when initiated treatment
- Patients who are taking L-DOPA/DCI combination of drugs continuously for more than 6 months
- Patients who have developed the wearing-off phenomenon
Exclusion Criteria
- Patients with epilepsy
- Patients who are taking L-DOPA single-agent
- Patients with a history of treatment with zonisamide
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: Change from baseline in total daily off time
- Secondary Outcome Measures
Name Time Method Efficacy: Change from baseline in UPDRS total score