Zonisamide a new drug drug for parkinson disease as additional drug to ongoing treatment for Parkinson: a randomized double blind placebo control study
Phase 1
- Conditions
- Health Condition 1: G20- Parkinsons disease
- Registration Number
- CTRI/2019/11/022095
- Lead Sponsor
- Atul Goel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Clinical diagnosis of Parkinson disease
2.Patient age 30 years and above
3.Symptomatic patient on levodopa therapy
4.Patients recieving individual dosages of levodopa (plus a DCI) and were stable for at least 28 days before study initiation
Exclusion Criteria
1.Atypical parkinsonism
2.Severe renal impairment
3.Pregnancy
4.Hypersensivity to sulphonamides
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy, safety and tolerability of daily doses of 50 mg of zonisamide (ZNS) administered as adjunctive treatment in patients with Parkinson disease and change from baseline in the total score of the Unified Parkinsonâ??s Disease Rating Scale (UPDRS) Part III at the final assessment point of 8 weeksTimepoint: 8 weeks
- Secondary Outcome Measures
Name Time Method 1. Secondary endpoints included changes from baseline in total daily â??offâ?? time; total scores of UPDRS Parts I, II, and IV; at final assessment at 8 weeks <br/ ><br>2. short term safety and tolerability of zonisamide <br/ ><br>3. to assess degree of depression severity in parkinson patients and change from baseline at 8 weeksTimepoint: 8 weeks