Patients with idiopathic Parkinson's disease and levodopa-induced dyskinesias MedDRA version: 13.1 Level: PT Classification code 10013916 Term: Dyskinesia System Organ Class: 10029205 - Nervous system disorders MedDRA version: 13.1 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders MedDRA version: 13.1 Level: HLT Classification code 10034005 Term: Parkinson's disease and parkinsonism System Organ Class: 10029205 - Nervous s
Conditions
Interventions
Product Name: Topiramate
Pharmaceutical Form: Capsule*
INN or Proposed INN: TOPIRAMATE
CAS Number: 97240794
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral us
Sponsors
Salford Royal NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate the effect of topiramate on parkinsonism.;Main Objective: To evaluate the antidyskinetic efficacy of topiramate in patients with PD and levodopa-induced dyskinesias in a randomized, double-blind, placebo-controlled, crossover trial;Primary end point(s): Investigator-rated dyskinesia severity will be the primary outcome measure. During each video assessment, dyskinesia severity will be rated during a five-minute observation period at intervals of 30 minutes, for a total duration of 150 minutes. This period will encompass the predicted duration of peak-dose dyskinesia. Dyskinesia severity will be rated by post hoc analysis of videotape recordings made after drug administration. A movement disorders specialist who is not involved in the levodopa challenges and who is blinded to the treatment arms will score the videotape. Dyskinesia will be rated using a 5-point objective dyskinesia intensity rating scale,[32] rating 7 body parts (each limb, face, neck and trunk), with a maximum possible total score 28, where: 0. No dyskinesia present. 1. Questionable or mild dyskinesia. 2. Moderate amplitude but quite apparent abnormal postures or movements that are not intrusive. 3. Large amplitude movements or postures that may distort and mildly or moderately disturb voluntary movements. 4. Severe and grotesque postures or movements that markedly disturb posture or ongoing voluntary activities. Total peak-dose dyskinesia, the area under the curve (AUC) summation, will be determined and the percent change from baseline evaluated. | — |
Countries
United Kingdom
Outcome results
None listed