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NCT00565201 · ClinicalTrials.gov registry record · Early Phase 1
Evaluation of BOTOX® With Rehabilitation Therapy for the Treatment of Wrist and Hand Spasticity in Post-Stroke Patients
A Early Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 25
- Enrollment target
NCT00565201 is a Early Phase 1 study that has completed, run by Emory University. The registered enrollment target is 25 participants.
The verdict
NCT00565201, a Early Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
The present study is designed to determine the safety and effectiveness of injections of BOTOX® in spastic muscles of the arm and hand compared with injections of saline (which would do nothing) when combined with rehabilitation therapy for the improvement of active function tasks in post-stroke patients. Injections will be targeted to reduce common spasticity patterns of the arm and hand which include: bent elbow, palm down forearm, bent wrist, thumb-in-palm, clenched fist, and other hand deformities. This will be done only at Emory University. Neither the doctor injecting the drug nor the subject receiving the drug will know if they are getting BOTOX® or saline. Which type of injection the subject receives will be completely randomized (like flipping a coin). All subjects will have rehabilitation therapy after their injections. Subjects will be assessed at a total of 5 scheduled visits (qualification (Week 1), Injection (Week 2), Evaluations on Weeks 8, 10, and 14. All subjects will receive rehabilitation therapy immediately after their injections for 1 hour a day, 3-5 times a week, for 4 weeks. The results from this project will provide valuable data on the ability of BOTOX® and physical rehabilitation to provide effective treatment to spastic muscles of the arm and hand after stroke. This project has the potential to increase the availability of effective rehabilitation techniques to patients with stroke.
Interventions
- DRUG Botox and rehab
- DRUG Placebo and rehab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2007-10 |
| Est. Completion | 2011-12 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00565201
The ClinicalTrials.gov registry entry for NCT00565201 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Botox and rehab is the first listed.
NCT00565201 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00565201 about?
NCT00565201 is a clinical study titled "Evaluation of BOTOX® With Rehabilitation Therapy for the Treatment of Wrist and Hand Spasticity in Post-Stroke Patients". The present study is designed to determine the safety and effectiveness of injections of BOTOX® in spastic muscles of the arm and hand compared with injections of saline (which would do nothing) when combined with rehabilitation therapy for the improvement of active function tasks in post-stroke pat...
What is the current status of trial NCT00565201?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 25 participants. The study started on 2007-10. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00565201?
The interventions under investigation include: Botox and rehab (DRUG), Placebo and rehab (DRUG).
Who is sponsoring clinical trial NCT00565201?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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