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NCT01491022 · ClinicalTrials.gov registry record · Phase 1
A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease
A Phase 1 study of Parkinson's Disease, sponsored by University of Miami.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT01491022: Completed Phase 1 study of Parkinson's Disease, sponsored by University of Miami.
NCT01491022 is a Phase 1 study of Parkinson's Disease that has completed, run by University of Miami. The registered enrollment target is 22 participants, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01491022, a Phase 1 study of Parkinson's Disease, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the effect of AMPYRA on a number of symptoms in Parkinson's disease. AMPYRA is a medication approved by FDA for gait dysfunction in multiple sclerosis. There are multiple studies to suggest that persons with multiple sclerosis benefit from this medication and have major improvements in gait after taking this medication. However, this medication was never studied in Parkinson's disease. This study aims to learn about possible benefits of AMPYRA in Parkinson's disease (PD).
Primary Outcome
The primary outcome measure will be the change in gait velocity as measured with by 3-dimensional gait analysis system.
Conditions Studied
Interventions
- DRUG Ampyra first, then Placebo
- DRUG placebo first, then Ampyra
Study Locations (1)
Florida
- University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2012-07 |
| Est. Completion | 2014-07 |
| Phase | Phase 1 |
What the finished NCT01491022 record still lists
NCT01491022 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 2 interventions - of which Ampyra first, then Placebo is the first listed.
NCT01491022 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01491022 about?
NCT01491022 is a clinical study titled "A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease". The purpose of this study is to evaluate the effect of AMPYRA on a number of symptoms in Parkinson's disease. AMPYRA is a medication approved by FDA for gait dysfunction in multiple sclerosis. There are multiple studies to suggest that persons with multiple sclerosis benefit from this medication and...
What is the current status of trial NCT01491022?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2012-07. Estimated completion is 2014-07.
What conditions does trial NCT01491022 study?
This clinical trial studies the following conditions: Parkinson's Disease.
What interventions are being tested in trial NCT01491022?
The interventions under investigation include: Ampyra first, then Placebo (DRUG), placebo first, then Ampyra (DRUG).
Who is sponsoring clinical trial NCT01491022?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01491022 being conducted?
This trial has 1 study location across Florida. 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 NCT01491022's enrollment target sits among peer trials
22 125th of 158 higher than 33 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.
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