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NCT04349176 · ClinicalTrials.gov registry record · Phase 3
Onabotulinum Dose Comparison in Chronic Migraine Superior to 100 Units?
A Phase 3 study, sponsored by United States Naval Medical Center, San Diego.
- Terminated
- Registry status
- Phase 3
- Development phase
- 35
- Enrollment target
NCT04349176 is a Phase 3 study that was terminated before completion, run by United States Naval Medical Center, San Diego. The registered enrollment target is 35 participants.
The verdict
NCT04349176, a Phase 3 study, was terminated before completion, sponsored by United States Naval Medical Center, San Diego.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 35 participants
- Enrollment target
Study Summary
The study will enroll patients through the Neurology Department at Naval Medical Center San Diego (NMCSD). Eligible participants will meet criteria for chronic migraine, but will not be excluded based on the presence of significant comorbidities. Participants with comorbidities and medication regimens commonly exhibited within real-world DOD medical settings will not be excluded, such as pain disorders, psychiatric illness, medication overuse, and those who have used prophylactic medication during the baseline period. This will comprise "Group A". A carefully screened group will comprise "Group B" and meet exclusion criteria designed to approximate that of the PREEMPT2 trial. Within each group, half of the patients (155U Arm) will be randomly selected to receive the standard 155U over 31 fixed sites every 12 weeks while the other half (100U Arm) will receive 100U over 19 fixed sites every 12 weeks. Minimum sample size for the entire cohort is 132 participants (maximum n = 180), with a minimum of 66 participants per comparison.
Interventions
- DRUG Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2017-05-12 |
| Est. Completion | 2022-12-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04349176
The ClinicalTrials.gov registry entry for NCT04349176 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United States Naval Medical Center, San Diego, which has 41 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Dose is the first listed.
NCT04349176 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04349176 about?
NCT04349176 is a clinical study titled "Onabotulinum Dose Comparison in Chronic Migraine Superior to 100 Units?". The study will enroll patients through the Neurology Department at Naval Medical Center San Diego (NMCSD). Eligible participants will meet criteria for chronic migraine, but will not be excluded based on the presence of significant comorbidities. Participants with comorbidities and medication regime...
What is the current status of trial NCT04349176?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 35 participants. The study started on 2017-05-12. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT04349176?
The interventions under investigation include: Dose (DRUG).
Who is sponsoring clinical trial NCT04349176?
This trial is sponsored by United States Naval Medical Center, San Diego, which has 41 total clinical trials registered on ClinicalTrials.gov.
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