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

ISRCTN	ISRCTN95151471
DOI	https://doi.org/10.1186/ISRCTN95151471
Secondary identifying numbers	2007 Neuro 12

Submission date: 20/05/2008
Registration date: 02/07/2008
Last edited: 09/05/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Montague Silverdale
Scientific

Salford Royal NHS Foundation Trust
Stott Lane
Salford
M6 8HD
United Kingdom

Phone	+44 1625 661782
Email	monty.silverdale@srft.nhs.uk

Study information

Study design	Multicentre, randomised, double-blind, placebo-controlled, crossover study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet.
Scientific title	Antidyskinetic properties of topiramate: a double-blind, placebo-controlled trial in patients with Parkinson's disease and levodopa-induced dyskinesias
Study objectives	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(s)	Leeds (West) Research Ethics Committee, 24/01/2008, ref: 07/H1307/205
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Topiramate
Primary outcome measure	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 study start date	01/07/2008
Completion date	01/01/2010

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	30
Key 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
Key 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
Date of first enrolment	01/07/2008
Date of final enrolment	01/01/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Salford Royal NHS Foundation Trust

Salford
M6 8HD
United Kingdom

Sponsor information

Salford Royal NHS Foundation Trust (UK)
Hospital/treatment centre

Clinical Sciences Building
Stott Lane
Salford
M6 8HD
England
United Kingdom

Phone	+44 161 206 5137
Email	rachel.georgiu@manchester.ac.uk
Website	http://www.srht.nhs.uk
"ROR"	https://ror.org/019j78370

Funders

Funder type

University/education

University of Manchester (UK)
Government organisation / Universities (academic only)

Alternative name(s): The University of Manchester, University of Manchester UK, University of Manchester in United Kingdom, UoM
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

09/05/2016: No publications found, verifying study status with principal investigator.