Contact information
Type
Scientific
Primary contact
Dr Montague Silverdale
ORCID ID
Contact details
Salford Royal NHS Foundation Trust
Stott Lane
Salford
M6 8HD
United Kingdom
+44 1625 661782
monty.silverdale@srft.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2007 Neuro 12
Study information
Scientific title
Antidyskinetic properties of topiramate: a double-blind, placebo-controlled trial in patients with Parkinson's disease and levodopa-induced dyskinesias
Acronym
Study hypothesis
Levodopa therapy is effective for the motor symptoms of Parkinson's disease. However, around half of patients develop abnormal involuntary movements, or dyskinesia, after 4 - 6 years of treatment. Current treatment interventions for this are not satisfactory in all cases.
Hypothesis:
Topiramate administration will attenuate levodopa-induced dyskinesia in patients with Parkinson's disease (PD) without worsening parkinsonism.
Ethics approval
Leeds (West) Research Ethics Committee, 24/01/2008, ref: 07/H1307/205
Study design
Multicentre, randomised, double-blind, placebo-controlled, crossover study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Parkinson's disease and levodopa-induced dyskinesia
Intervention
This is a randomised, crossover study.
Topiramate group: start dose 25 mg/day orally (p.o.), to be up-titrated by 25 mg/day weekly to target dose of 100 mg/day in two divided doses. Participants to stay on maintenance dose for two weeks prior to assessment. Participants will attend having not taken usual morning medications, and response to these medications will then be assessed.
Control: placebo capsules, identical in appearance. To be titrated on same schedule as topiramate.
Following a two-week down-titration period, there will be a further two-week washout period before crossover.
Intervention type
Drug
Phase
Not Specified
Drug names
Topiramate
Primary outcome measures
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
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.
2. Subject-rated dyskinesia severity:
2.1. Lang-Fahn Activities of Daily Living Dyskinesia Scale. Timepoints of assessment: week 0, 6, and 16.
2.2. Clinical Global Impression of change, assessed weekly during dose titration and at weeks 6 and 16
2.3. UPDRS Part IV. Timepoints of assessment: week 0, 6 and 16.
3. Effects on mood and activities of daily living:
3.1. UPDRS Part I, II. Timepoints of assessment: week 0, 6 and 16.
3.2. Geriatric Depression Scale-15. Timepoints of assessment: week 0, 2, 4, 6, 10, 12, 14 and 16.
4. Excessive daytime sleepiness: Epworth Sleepiness Scale. Timepoints of assessment: week 0, 2, 4, 6, 10, 12, 14 and 16.
Overall trial start date
01/07/2008
Overall trial end date
01/01/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
30
Participant 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
Recruitment start date
01/07/2008
Recruitment end date
01/01/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Salford Royal NHS Foundation Trust
Salford
M6 8HD
United Kingdom
Sponsor information
Organisation
Salford Royal NHS Foundation Trust (UK)
Sponsor details
Clinical Sciences Building
Stott Lane
Salford
M6 8HD
United Kingdom
+44 161 206 5137
rachel.georgiu@manchester.ac.uk
Sponsor type
Government
Website
Funders
Funder type
University/education
Funder name
University of Manchester (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary