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.
Phase 2
- Conditions
- Health Condition 1: G20- Parkinsons disease
- Registration Number
- CTRI/2019/02/017634
- Lead Sponsor
- Sun Pharmaceutical Industries Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in UPDRS III tremor score from baselineTimepoint: Change in UPDRS III tremor score from baseline
- Secondary Outcome Measures
Name Time Method 1.Change from baseline in UPDRS total and subscores <br/ ><br>2.Change from baseline in TETRAS. <br/ ><br>3.Change from baseline on accelerometric tremor analysis <br/ ><br>4.To determine adverse effects of intervention recorded in different treatment groups. <br/ ><br>Timepoint: At the end of 12 weeks