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NCT03698409 · ClinicalTrials.gov registry record · Phase 4
Onabotulinumtoxin Type A Reconstitution With Preserved Versus Preservative-free Saline in Chronic Migraine.
A Phase 4 study, sponsored by State University of New York - Upstate Medical University.
- Completed
- Registry status
- Phase 4
- Development phase
- 68
- Enrollment target
NCT03698409 is a Phase 4 study that has completed, run by State University of New York - Upstate Medical University. The registered enrollment target is 68 participants.
The verdict
NCT03698409, a Phase 4 study, has completed, sponsored by State University of New York - Upstate Medical University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 68 participants
- Enrollment target
Study Summary
A growing body of literature on the cosmetic use of OnabotulinumtoxinA has suggested that the use of preserved saline exerts a local anesthetic effect, and reduces the procedure discomfort when used in reconstitution in lieu of preservative-free saline. However, this has never been studied in chronic migraine. While reducing discomfort is a desirable target in all procedures, it has a special importance in the use of OnabotulinumtoxinA for chronic migraine due to the numerous injection locations each session (31 sites) and the ubiquity of scalp tenderness in this population. In addition, the pain during procedure is a known migraine trigger for many of these patients. We hypothesize that preserved saline (known as bacteriostatic saline) produces lower procedure-related discomfort when used as a dissolving solution for OnabotulinumtoxinA in individuals with chronic migraine as opposed to using preservative-free saline. In addition, we hypothesize that reduction of procedure-relate pain during the injections will also result in reduced migraine/headache attacks in the week immediately following the procedure.
Interventions
- DRUG Preserved saline in reconstitution of Botox
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2019-01-01 |
| Est. Completion | 2019-08-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03698409
The ClinicalTrials.gov registry entry for NCT03698409 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is State University of New York - Upstate Medical University, which has 113 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Preserved saline in reconstitution of Botox is the first listed.
NCT03698409 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03698409 about?
NCT03698409 is a clinical study titled "Onabotulinumtoxin Type A Reconstitution With Preserved Versus Preservative-free Saline in Chronic Migraine.". A growing body of literature on the cosmetic use of OnabotulinumtoxinA has suggested that the use of preserved saline exerts a local anesthetic effect, and reduces the procedure discomfort when used in reconstitution in lieu of preservative-free saline. However, this has never been studied in chroni...
What is the current status of trial NCT03698409?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 68 participants. The study started on 2019-01-01. Estimated completion is 2019-08-01.
What interventions are being tested in trial NCT03698409?
The interventions under investigation include: Preserved saline in reconstitution of Botox (DRUG).
Who is sponsoring clinical trial NCT03698409?
This trial is sponsored by State University of New York - Upstate Medical University, which has 113 total clinical trials registered on ClinicalTrials.gov.
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