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.

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/02/017634

Enrollment

Registered

2019-02-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G20- Parkinsons disease

Interventions

Intervention1: Zonisamide 25 mg: Patients meeting inclusion criteria to continue previous treatment + Zonisamide 25 mg OD, given for 12 weeks Control Intervention1: Similar looking Placebo: Patients m

Eligibility

Inclusion 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

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 •Hepatic or renal disease •Pregnancy and breast feeding •Known allergy to Zonisamide

Design outcomes

Primary

Measure	Time frame
Change in UPDRS III tremor score from baselineTimepoint: Change in UPDRS III tremor score from baseline	—

Secondary

Measure	Time frame
1.Change from baseline in UPDRS total and subscores 2.Change from baseline in TETRAS. 3.Change from baseline on accelerometric tremor analysis 4.To determine adverse effects of intervention recorded in different treatment groups. Timepoint: At the end of 12 weeks	—

Countries

India

Contacts

Public ContactProf Vinay Goyal

AIIMS, New Delhi

drvinaygoyal@gmail.com9810470250

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026