This study will evaluate the responsiveness of a variety of available dyskinesia rating
scales to treatment with amantadine or placebo in Parkinson's disease patients with
dyskinesia. The study will be a parallel, double-blind, randomized trial of 68 patients
treated with amantadine or placebo for 8 weeks. Pre-treatment evaluations will be performed
and compared to end of study evaluations on the best treatment dose (200 or 300 mg amantadine
or matching placebo) daily. Safety evaluations will be conducted.
The responsiveness of the different scales will be evaluated statistically with a mixed model
in which changes in the outcome measures over time will include a fixed effect of treatment
group assignment. The model will additionally account for random effects of intercepts (the
scale scores at baseline) that will include both random variation (person-specific) and
specific variation associated with rate of change in outcome. The investigators may include
adjustments for possible confounding covariates, including baseline demographics and center.
The goal of the program is to provide researchers with the best scale(s) to distinguish
dyskinesia change in Parkinson's disease (PD) associated with amantadine in comparison to
placebo and to establish the magnitude of effect achievable with amantadine as a comparator
"gold standard" that must be met or surpassed by future anti-dyskinetic agents. Additionally,
with the use of paper and pencil questionnaires, the study will investigate the impact of
patient optimism and patient and rater expectation of positive effects on the dyskinesia
rating outcomes.
Phase:
Phase 4
Details
Lead Sponsor:
Rush University Medical Center
Collaborator:
Michael J. Fox Foundation for Parkinson's Research