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NCT01071395 · ClinicalTrials.gov registry record · Phase 4
Validation of Dyskinesia Rating Scales
A Phase 4 study of Parkinson's Disease, sponsored by Rush University Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 68
- Enrollment target
- 8
- Study locations
NCT01071395 is a Phase 4 study of Parkinson's Disease that has completed, run by Rush University Medical Center. The registered enrollment target is 68 participants, below the 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (89% lower). The trial reports 8 study locations across 7 states.
The verdict
NCT01071395, a Phase 4 study of Parkinson's Disease, has completed, sponsored by Rush University Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 68 participants
- Enrollment target
- 8
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Amantadine
Study Locations (8)
Other
- Universitatsklinik fur Neurologie - Innsbruck
- Centre d'investigation Clinique, CHU de Toulouse - Toulouse
Alabama
- University of Alabama-Birmingham (UAB) - Birmingham
Florida
- University of South Florida - Tampa
Illinois
- Rush University Medical Center - Chicago
North Carolina
- Duke University - Durham
Oregon
- Oregon Health & Science University (OHSU) - Portland
Ontario
- Toronto Western Hospital (Movement Disorder Center) - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2010-01 |
| Est. Completion | 2013-06 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01071395
The ClinicalTrials.gov registry entry for NCT01071395 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (89% lower). The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01071395 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Other, Alabama, Florida.
Frequently Asked Questions
What is clinical trial NCT01071395 about?
NCT01071395 is a clinical study titled "Validation of Dyskinesia Rating Scales". 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...
What is the current status of trial NCT01071395?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 68 participants. The study started on 2010-01. Estimated completion is 2013-06.
What conditions does trial NCT01071395 study?
This clinical trial studies the following conditions: Parkinson's Disease.
What interventions are being tested in trial NCT01071395?
The interventions under investigation include: Placebo (DRUG), Amantadine (DRUG).
Who is sponsoring clinical trial NCT01071395?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01071395 being conducted?
This trial has 8 study locations across Alabama, Florida, Illinois, North Carolina, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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