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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: Completed Phase 4 study of Parkinson's Disease, sponsored by Rush University Medical Center.

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 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (89% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Analyses of primary outcome measures tested sensitivity to change in dyskinesia (time effect) as well as sensitivity to differences in treatment effect (time-by-treatment interaction). These analyses were conducted using repeated-measures ANOVA (RM-ANOVA) or nonparametric analyses (Friedman's ANOVA with follow-up Wilcoxon tests). The RM-ANOVAs tested for changes in scale scores over baseline, week 4, and week 8 visits across the entire sample (time effect), as well as differences in these change

Conditions Studied

Parkinson's Disease

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

FieldValue
Enrollment Target 68 participants
Start Date 2010-01
Est. Completion 2013-06
Phase Phase 4
Rush University Medical Center

320 total trials

What the finished NCT01071395 record still lists

NCT01071395 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (89% lower).

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 lists 8 locations in 7 states (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.

Learn More About Clinical Trials

Similar trials for Parkinson's Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01071395's enrollment target sits among peer trials

68 69th of 158 higher than 90 of 158 other Parkinson's Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Parkinson's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01071395, the US trial registry maintained by the National Library of Medicine. NCT01071395 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.