Antidyskinetic properties of topiramate: a double-blind, placebo-controlled trial in patients with Parkinson's disease and levodopa-induced dyskinesias

Not Applicable

Completed

Conditions: Parkinson's disease and levodopa-induced dyskinesia
Nervous System Diseases
Parkinson's disease

Registration Number: ISRCTN95151471

Lead Sponsor: Salford Royal NHS Foundation Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

1. Both males and females, no age limits
2. Patients with Parkinson's disease as defined by UK Parkinson's Disease Society Brain Bank criteria
3. Current use of levodopa, dose to be stable for one month prior to enrolment
4. Stable levodopa-induced dyskinesias

Exclusion Criteria

1. Hypersensitivity to topiramate or its excipients
2. Prior surgery for PD
3. Hoehn and Yahr score of 5 when off
4. Dementia
5. History of nephrolithiasis, renal impairment, liver disease, glaucoma
6. Pregnancy and breastfeeding
7. Premenopausal females and males not using adequate contraception
8. Use of other antiepileptic drugs, carbonic anhydrase inhibitors, metformin, digoxin or illicit drugs

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Investigator-rated dyskinesia severity. To be scored by a blinded assessor from video recordings of participants, every 30 minutes for a total of 150 minutes. Dyskinesia to be rated at each time-point using a 5-point objective dyskinesia intensity rating scale, rating seven body parts (each limb, face, trunk and neck) with a maximum possible score of 28 at each time point. Timepoints of assessment: baseline (week 0), end of Arm 1 (week 6) and end of Arm 2 (week 16)

Secondary Outcome Measures

Name	Time	Method
1. Investigator-rated parkinsonism. Unified Parkinson's Disease Rating Scale (UPDRS) part III to be assessed at 30-minute intervals during clinical assessment. Timepoints of assessment: week 0, 6 and 16.<br>2. Subject-rated dyskinesia severity: <br>2.1. Lang-Fahn Activities of Daily Living Dyskinesia Scale. Timepoints of assessment: week 0, 6, and 16. <br>2.2. Clinical Global Impression of change, assessed weekly during dose titration and at weeks 6 and 16 <br>2.3. UPDRS Part IV. Timepoints of assessment: week 0, 6 and 16.<br>3. Effects on mood and activities of daily living: <br>3.1. UPDRS Part I, II. Timepoints of assessment: week 0, 6 and 16. <br>3.2. Geriatric Depression Scale-15. Timepoints of assessment: week 0, 2, 4, 6, 10, 12, 14 and 16. <br>4. Excessive daytime sleepiness: Epworth Sleepiness Scale. Timepoints of assessment: week 0, 2, 4, 6, 10, 12, 14 and 16.