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NCT03576001 · ClinicalTrials.gov registry record · Phase 2
Multimodality Intervention for Function and Metabolism in SCI
A Phase 2 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
NCT03576001 is a Phase 2 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 84 participants.
The verdict
NCT03576001, a Phase 2 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
Study Summary
The proposed phase 2 trial a randomized, placebo-controlled, parallel group trial in persons with cervical or thoracic SCI, AIS grade A, B, C, or D, 6 months or later after injury. The trial will test the hypothesis that a Home-Based Multimodality Functional Recovery and Metabolic Health Enhancement Program that addresses multiple pathophysiologic factors in SCI and includes functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry and an androgen will be more efficacious than functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry plus placebo in improving aerobic capacity, function, metabolism, bone health, and wellbeing.
Interventions
- DRUG Testosterone Undecanoate
- BEHAVIORAL hybrid exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2019-08-23 |
| Est. Completion | 2025-03-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03576001
The ClinicalTrials.gov registry entry for NCT03576001 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Testosterone Undecanoate is the first listed.
NCT03576001 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03576001 about?
NCT03576001 is a clinical study titled "Multimodality Intervention for Function and Metabolism in SCI". The proposed phase 2 trial a randomized, placebo-controlled, parallel group trial in persons with cervical or thoracic SCI, AIS grade A, B, C, or D, 6 months or later after injury. The trial will test the hypothesis that a Home-Based Multimodality Functional Recovery and Metabolic Health Enhancement...
What is the current status of trial NCT03576001?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2019-08-23. Estimated completion is 2025-03-30.
What interventions are being tested in trial NCT03576001?
The interventions under investigation include: Testosterone Undecanoate (DRUG), hybrid exercise (BEHAVIORAL).
Who is sponsoring clinical trial NCT03576001?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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