CTRI/2019/02/017634
Recruiting
Phase 2
Randomised Controlled Trial Comparing Efficacy of Zonisamide 25 mg given in addition to standard treatment with standard treatment alone in Tremor dominant Parkinsonâ??s Disease- A Pilot study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: G20- Parkinsons disease
- Sponsor
- Sun Pharmaceutical Industries Ltd
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •PD diagnosed according to UKPD Brain Bank criteria
- •Patients who meet criteria for tremor dominant PD, as described in methodology below.
- •Men and women of age 18 to 85\.
- •PD patients on stable dose of antiparkinsonian drug for last 3 months.
Exclusion Criteria
- •Patients of Atypical PD (diagnosed as per clinical criteria)
- •Patients of PD on other non\- antiparkinsonian drugs which might affect tremor, such as beta\-agonists, beta\- blockers, anti\-epileptics such as phenytoin, valproate, carbamazepine.
- •History of psychiatric illness
- •Severe cognitive impairment(MMSE \<\=21\)
- •Hepatic or renal disease
- •Pregnancy and breast feeding
- •Known allergy to Zonisamide
Outcomes
Primary Outcomes
Not specified
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