Health Condition 1: G20- Parkinsons disease
Conditions
Interventions
Intervention1: Zonisamide: The eligibility of patients will be confirmed immediately before the treatment period (baseline, week 0). Eligible patients were randomly allocated to 1 of 2 groups, and adm
Sponsors
Atul Goel
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Atypical parkinsonism 2. Severe renal impairment 3. Pregnancy 4. Hypersensivity to sulphonamides
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 2. short term safety and tolerability of zonisamide 3. to assess degree of depression severity in parkinson patients and change from baseline at 8 weeksTimepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactAtul Goel
JIPMER, PONDICHERRY
Outcome results
None listed