Validation of Dyskinesia Rating Scales

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rush University Medical Center
• Collaborator: Michael J. Fox Foundation for Parkinson's Research
• Treatments: Amantadine

Criteria

Inclusion Criteria:

1. Parkinson's disease patient, defined by United Kingdom Brain Bank criteria

2. Current age between 30-90

3. Clinically pertinent dyskinesias defined by Clinical Gl;obal Impression-severity score (see attachment) > 3 (mild) established by clinician's total assessment of patient including objective observation during the screening process. *

4. Documentation of creatinine level at screening evaluation that is within the normal range for the local university laboratory.

5. Stable doses of all antiparkinsonian medications for at least 4 weeks

6. No treatment with amantadine for at least 3 months.

7. Presence of a caregiver willing to participate in the study

8. Subjects/caregivers must demonstrate the capacity to complete an accurate home diary based on training and evaluation during the screening period (see attached training rules).

9. Subjects must be able to provide written informed consent.

10. If the subject received amantadine in the past, the drug was stopped for reason other than adverse events.

11. 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.

12. The subject must be willing to participate in all study related activities and visits.

Exclusion Criteria:

1. Subjects who have had prior brain surgery.

2. Subjects with other major illnesses that could be complicated by amantadine exposure, including glaucoma, current hallucinations, urinary retention.

3. Subjects with dementia, depression and psychosis as determined by clinical examination.