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NCT01896128 · ClinicalTrials.gov registry record · Phase 2
Combining Armodafinil With Neuro-rehabilitation to Improve Neurological Recovery and Reduce Disability Post-Stroke
A Phase 2 study of Stroke and Cerebrovascular Accident, sponsored by Burke Rehabilitation Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT01896128: Completed Phase 2 study of Stroke and Cerebrovascular Accident, sponsored by Burke Rehabilitation Hospital.
NCT01896128 is a Phase 2 study of Stroke and Cerebrovascular Accident that has completed, run by Burke Rehabilitation Hospital. The registered enrollment target is 19 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01896128, a Phase 2 study of Stroke and Cerebrovascular Accident, has completed, sponsored by Burke Rehabilitation Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
Armodafinil is an FDA approved medication with wakefulness-promoting properties. It is a relatively safe agent with interesting neurochemical effects on the catecholamine system, producing an improvement in cognitive function, particularly working memory in humans. When combined with intensive task-related training, armodafinil may accelerate motor recovery in chronic stroke patients. The primary aim of this study is to determine whether administration of armodafinil during subacute post-stroke rehabilitation will augment cortical plasticity and enhance motor recovery. The primary hypothesis suggests that cortical plasticity will be enhanced by armodafinil and, therefore, will induce an improvement in motor function and better performances on measures of motor control.
Primary Outcome
Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had a stroke.The maximum possible score in Fugl-Meyer scale is 226, which corresponds to full sensory-motor recovery. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Armodafinil
Study Locations (1)
New York
- The Burke Rehabilitation Hospital - White Plains
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2008-01 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
What the finished NCT01896128 record still lists
NCT01896128 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Stroke appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01896128 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01896128 about?
NCT01896128 is a clinical study titled "Combining Armodafinil With Neuro-rehabilitation to Improve Neurological Recovery and Reduce Disability Post-Stroke". Armodafinil is an FDA approved medication with wakefulness-promoting properties. It is a relatively safe agent with interesting neurochemical effects on the catecholamine system, producing an improvement in cognitive function, particularly working memory in humans. When combined with intensive task-...
What is the current status of trial NCT01896128?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2008-01. Estimated completion is 2015-07.
What conditions does trial NCT01896128 study?
This clinical trial studies the following conditions: Stroke, Cerebrovascular Accident, Hemiparesis.
What interventions are being tested in trial NCT01896128?
The interventions under investigation include: Placebo (DRUG), Armodafinil (DRUG).
Who is sponsoring clinical trial NCT01896128?
This trial is sponsored by Burke Rehabilitation Hospital, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01896128 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT01896128's enrollment target sits among peer trials
19 382nd of 454 higher than 71 of 454 other Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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