Antidyskinetic Properties of Topiramate: A Double-Blind, Placebo-Controlled Trial in Patients with Parkinson's Disease and Levodopa-Induced Dyskinesias - Antidyskinetic properties of topiramate

• Conditions: Patients with idiopathic Parkinson's disease and levodopa-induced dyskinesias; MedDRA version: 13.1Level: PTClassification code 10013916Term: DyskinesiaSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 13.1Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 13.1Level: HLTClassification code 10034005Term: Parkinson's disease and parkinsonismSystem Organ Class: 10029205 - Nervous system disorders

• Registration Number: EUCTR2007-002467-27-GB
• Lead Sponsor: Salford Royal NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients meet UK Parkinson's Disease Society Brain Bank diagnostic criteria for idiopathic Parkinson's Disease (PD). Patients taking levodopa, with stable levodopa-induced dyskinesias. Stable antiparkinsonian medications for at least one month prior to enrollment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Hypersensitivity to topiramate or its excipients. Prior surgery for PD. Hoehn and Yahr score of 5 when 'off'. History of nephrolithiasis, renal impairment, liver disease, glaucoma. Pregnancy or breastfeeding. Premenopausal females and males not using adequate contraception. Use of other antiepileptic drugs, carbonic anhydrase inhibitors, metformin, digoxin, illicit drugs. Dementia as defined by MMSE<24

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified