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NCT05492695 · ClinicalTrials.gov registry record · Phase 4
Tandem OnabotulinumtoxinA Galcanezumab Emerging Therapeutic Headache Elimination Research Study
A Phase 4 study, sponsored by Diamond Headache Clinic.
- Terminated
- Registry status
- Phase 4
- Development phase
- 2
- Enrollment target
NCT05492695 is a Phase 4 study that was terminated before completion, run by Diamond Headache Clinic. The registered enrollment target is 2 participants.
The verdict
NCT05492695, a Phase 4 study, was terminated before completion, sponsored by Diamond Headache Clinic.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 2 participants
- Enrollment target
Study Summary
This is a multicenter, double-blind, placebo-controlled study assessing the effectiveness of Galcanezumab as an add-on therapy for Migraine participants on a stable migraine prophylaxis regimen including Botox with or without one other migraine prophylaxis agent (BMPT), who have persistent unmet need. The study population will consist of approximately 150 participants ages 18-65 who report at least a 30% reduction in monthly migraine days from BMPT and still experience an average of ≥ 6 migraine days per month, following International Classification of Headache Disorders (ICHD-3) criteria. Subjects should be stable on at least 2, but no more than 8, consecutive injection cycles of Botox. Overall migraine day reduction will be assessed in the participants based on participant self-report (via daily electronic diaries) and medical record review.
Interventions
- OTHER Placebo
- DRUG Galcanezumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2022-10-01 |
| Est. Completion | 2023-09-28 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05492695
The ClinicalTrials.gov registry entry for NCT05492695 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Diamond Headache Clinic, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05492695 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05492695 about?
NCT05492695 is a clinical study titled "Tandem OnabotulinumtoxinA Galcanezumab Emerging Therapeutic Headache Elimination Research Study". This is a multicenter, double-blind, placebo-controlled study assessing the effectiveness of Galcanezumab as an add-on therapy for Migraine participants on a stable migraine prophylaxis regimen including Botox with or without one other migraine prophylaxis agent (BMPT), who have persistent unmet nee...
What is the current status of trial NCT05492695?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 2 participants. The study started on 2022-10-01. Estimated completion is 2023-09-28.
What interventions are being tested in trial NCT05492695?
The interventions under investigation include: Placebo (OTHER), Galcanezumab (DRUG).
Who is sponsoring clinical trial NCT05492695?
This trial is sponsored by Diamond Headache Clinic, which has 3 total clinical trials registered on ClinicalTrials.gov.
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