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NCT01032239 · ClinicalTrials.gov registry record · Phase 4
SISTERS: Spasticity In Stroke Study - Randomized Study
A Phase 4 study, sponsored by MedtronicNeuro.
- Completed
- Registry status
- Phase 4
- Development phase
- 61
- Enrollment target
NCT01032239 is a Phase 4 study that has completed, run by MedtronicNeuro. The registered enrollment target is 61 participants.
The verdict
NCT01032239, a Phase 4 study, has completed, sponsored by MedtronicNeuro.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 61 participants
- Enrollment target
Study Summary
To demonstrate that Intrathecal Baclofen (ITB) Therapy, compared to Best Medical Treatment (BMT), has superior efficacy in the treatment of severe spasticity in adult post-stroke patients with generalized spastic hypertonia who have not reached their therapy goal with other treatment interventions assessed by a decrease in the average Ashworth Scale (AS) score in the lower extremities.
Interventions
- DRUG intrathecal baclofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2009-11 |
| Est. Completion | 2016-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01032239
The ClinicalTrials.gov registry entry for NCT01032239 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MedtronicNeuro, which has 51 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which intrathecal baclofen is the first listed.
NCT01032239 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01032239 about?
NCT01032239 is a clinical study titled "SISTERS: Spasticity In Stroke Study - Randomized Study". To demonstrate that Intrathecal Baclofen (ITB) Therapy, compared to Best Medical Treatment (BMT), has superior efficacy in the treatment of severe spasticity in adult post-stroke patients with generalized spastic hypertonia who have not reached their therapy goal with other treatment interventions a...
What is the current status of trial NCT01032239?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 61 participants. The study started on 2009-11. Estimated completion is 2016-09.
What interventions are being tested in trial NCT01032239?
The interventions under investigation include: intrathecal baclofen (DRUG).
Who is sponsoring clinical trial NCT01032239?
This trial is sponsored by MedtronicNeuro, which has 51 total clinical trials registered on ClinicalTrials.gov.
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