Clinical trial NCT01789047: Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease
Official title: Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Idiopathic Parkinson's Disease
Drug Induced Dyskinesia
Keywords: Parkinson's disease
dyskinesia
Indonesia
amantadine
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2013-02-11
Enrollment: 42
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will involve an eighteen-week, double-blind, placebo-controlled parallel designed comparison between add-on topiramate and add-on placebo to stable treatment with amatadine in the treatment of Parkinson's disease (PD) patients who continue to have dyskinesia on amantadine.

Detailed description: We conducted a randomized placebo controlled trial of topiramate in PD dyskinetic subjects already on amantadine but with continuing dyskinesia. Topiramate or placebo was introduced in blinded fashion with a gradual titration (topiramate 25-150 mg/d) over 6 weeks and then a maintenance period of 8 weeks. The primary outcome of interest was change from baseline to end of study in total Unified Dyskinesia Rating Scale (UDysRS) score using Intention to Treat analysis.

Eligibility criteria: Inclusion Criteria:

1. Parkinson's disease patient, defined by United Kingdom (UK) Brain Bank criteria
2. Current age between 30-90
3. Clinically pertinent dyskinesias defined by Clinical Global Impression - Severity (CGI-s) score (see attachment) \> 3 (mild) established by clinician's total assessment of patient including objective observation during the screening process. \*
4. Stable doses of all antiparkinsonian medications for at least 4 weeks
5. Stable treatment with at least 200 mg amantadine for at least 4 weeks.
6. Presence of a caregiver willing to participate in the study
7. In the opinion of the enrolling investigator, the subject will be able to maintain current dosing schedule of antiparkinsonian drugs for the duration of the trial.
8. Subjects must be free of dementia, depression and psychosis as determined by clinical examination.
9. The subject must be willing to participate in all study related activities and visits.

Exclusion criteria:

1. Any subjects with clinical evidence suggestive of an atypical or secondary form of Parkinson's Disease
2. Any subject who, in the opinion of the Principal Investigator, has a concomitant medical illness which would preclude them from being treated with amantadine,
3. Any subject who, in the opinion of the Principal Investigator, will be unable to maintain current stable dosing of their anti-parkinsonian medications for the duration of the trial,
4. Any subject with evidence for dementia, depression, or psychosis, as determined by clinical examination.
5. Any subject who has not signed informed consent, or unable or unwilling to participate in all of the study related activities.

Primary outcomes:
measure: The Unified Dyskinesia Rating Scale (UDysRS)
timeFrame: Change from baseline to week 14 (end of study) on the Unified Dyskinesia Rating Scale
Secondary outcomes:
Other outcomes:
measure: Clinical Global Impression - Change Score
timeFrame: Assessed at Week 10 and 14 by blinded treating physician and subject
measure: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: Assessed at baseline, week 6, week 10 and week 14
measure: Hoehn & Yahr Staging
timeFrame: Assessment completed at baseline, week 6, week 10 and week 14
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
Study officials:
affiliation: Rush University Medical Center
name: Christopher G Goetz, MD
role: PRINCIPAL_INVESTIGATOR
References: