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NCT01605825 · ClinicalTrials.gov registry record · Phase 2
A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke
A Phase 2 study of Ischemic Stroke, sponsored by Acorda Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 83
- Enrollment target
- 20
- Study locations
NCT01605825: Completed Phase 2 study of Ischemic Stroke, sponsored by Acorda Therapeutics.
NCT01605825 is a Phase 2 study of Ischemic Stroke that has completed, run by Acorda Therapeutics. The registered enrollment target is 83 participants, below the 1,462-participant average among 66 other Ischemic Stroke trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01605825, a Phase 2 study of Ischemic Stroke, has completed, sponsored by Acorda Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 83 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multi-center, safety and tolerability study in subjects with chronic stable sensorimotor deficits after ischemic stroke. It has been designed as a double-blind, placebo-controlled, 2-period crossover study.
Primary Outcome
A TEAE is defined as any adverse event with date of onset (or worsening) on or after the start-date of double-blind treatment through 7 days after the last dose of double-blind treatment. The severity categories of mild, moderate or severe, are defined below: * Mild is defined as causing no limitation of usual activities * Moderate is defined as causing some limitation of usual activities * Severe is defined as causing inability to carry out usual activities
Conditions Studied
Interventions
- DRUG placebo/dalfampridine-ER
- DRUG dalfampridine-ER/placebo
Study Locations (20)
New York
- Acorda Site #019 - Buffalo
- Acorda Site #007 - West Haverstraw
- Acorda Site #004 - White Plains
California
- Acorda Site #018 - La Jolla
- Acorda Site #016 - Newport Beach
Florida
- Acorda Site #002 - Atlantis
- Acorda Site #015 - Fort Lauderdale
Alabama
- Acorda Site #011 - Birmingham
Connecticut
- Acorda Site #006 - Fairfield
Georgia
- Acorda Site #003 - Decatur
Kentucky
- Acorda Site #021 - Lexington
Massachusetts
- Acorda Site #009 - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2012-05 |
| Est. Completion | 2013-03 |
| Phase | Phase 2 |
What the finished NCT01605825 record still lists
NCT01605825 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 1,462-participant average among 66 other Ischemic Stroke trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Ischemic Stroke appearing as the primary indexed condition, and to 2 interventions - of which placebo/dalfampridine-ER is the first listed.
NCT01605825 names 20 study sites across 16 states, led by New York, California, Florida.
Frequently Asked Questions
What is clinical trial NCT01605825 about?
NCT01605825 is a clinical study titled "A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke". This is a multi-center, safety and tolerability study in subjects with chronic stable sensorimotor deficits after ischemic stroke. It has been designed as a double-blind, placebo-controlled, 2-period crossover study.
What is the current status of trial NCT01605825?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2012-05. Estimated completion is 2013-03.
What conditions does trial NCT01605825 study?
This clinical trial studies the following conditions: Ischemic Stroke.
What interventions are being tested in trial NCT01605825?
The interventions under investigation include: placebo/dalfampridine-ER (DRUG), dalfampridine-ER/placebo (DRUG).
Who is sponsoring clinical trial NCT01605825?
This trial is sponsored by Acorda Therapeutics, which has 36 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01605825 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ischemic Stroke
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 NCT01605825's enrollment target sits among peer trials
83 34th of 66 higher than 33 of 66 other Ischemic Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ischemic Stroke 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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