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NCT03373162 · ClinicalTrials.gov registry record · Phase 4
Functional Effects of Botox on the Brain Using MRS and fMRI
A Phase 4 study of Healthy, sponsored by University of California, Irvine.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT03373162 is a Phase 4 study of Healthy that has completed, run by University of California, Irvine. The registered enrollment target is 10 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03373162, a Phase 4 study of Healthy, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The injection of BOTOX into peripheral muscles has been shown to have therapeutic effects in a growing number of indications including disorders involving skeletal muscle (e.g., strabismus, blepharospasm, cervical dystonia, spasticity, cosmetic), smooth muscle (e.g., bladder), glands (axillary hyperhidrosis) and nociceptive pain (e.g. migraine) (Brin. 2014). Recently, several studies have suggested that peripheral BOTOX injections in the region of the glabellar lines (muscles around the eyes) may be effective in treating major depression and chronic migraine. However, the mechanism underlying the effect of peripheral BOTOX injections on the brain is not well understood. Therefore, the Investigators propose to further explore the functional effects of BOTOX injections on brain in healthy controls. The approach will involve the measurement of brain metabolites in the brainstem using MRS as well as an investigation of the functioning and connectivity between regions of the brain using resting state MRI and high resolution fMRI.
Conditions Studied
Interventions
- DRUG onabotulinumtoxinA
Study Locations (1)
California
- University of California, Irvine - Irvine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-09-30 |
| Est. Completion | 2018-03-16 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03373162
The ClinicalTrials.gov registry entry for NCT03373162 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which onabotulinumtoxinA is the first listed.
NCT03373162 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03373162 about?
NCT03373162 is a clinical study titled "Functional Effects of Botox on the Brain Using MRS and fMRI". The injection of BOTOX into peripheral muscles has been shown to have therapeutic effects in a growing number of indications including disorders involving skeletal muscle (e.g., strabismus, blepharospasm, cervical dystonia, spasticity, cosmetic), smooth muscle (e.g., bladder), glands (axillary hyper...
What is the current status of trial NCT03373162?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2017-09-30. Estimated completion is 2018-03-16.
What conditions does trial NCT03373162 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT03373162?
The interventions under investigation include: onabotulinumtoxinA (DRUG).
Who is sponsoring clinical trial NCT03373162?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03373162 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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