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NCT01854385 · ClinicalTrials.gov registry record · Phase 2
Sumatriptan as Treatment for Post-traumatic Headache
A Phase 2 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT01854385 is a Phase 2 study that has completed, run by University of Washington. The registered enrollment target is 40 participants.
The verdict
NCT01854385, a Phase 2 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
This phase II evaluation of sumatriptan as a treatment for post traumatic headache (PTH) will examine the methods and approach necessary to take the next step to a phase III trial. The sample will include 40 persons with mild complicated, moderate or severe TBI who will be recruited from patients discharged from the acute rehabilitation unit as well as outpatient clinics and the community who are between 3 and 24 months of injury and will be followed over 3 months. The investigators plan to enroll those who have moderate to severe headache with frequency of at least four and up to a maximum of fifteen total headache days per month and at least three months after discharge from hospital. The investigators will use headache diaries to track the headaches for a month. If subjects still have significant headache, the investigators will instruct them in the use of sumatriptan 100 mg. to treat headaches. The subjects will continue to keep daily headache diaries. The investigators will evaluate them at baseline, Day 30 and Day 90. Each subject will receive weekly telephone follow up calls from the research staff. The investigators will measure pain severity, duration, recurrence of headaches, and side effects and how well persons with TBI can use headache diaries.
Interventions
- DRUG Sumatriptan 100 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2013-06 |
| Est. Completion | 2018-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01854385
The ClinicalTrials.gov registry entry for NCT01854385 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sumatriptan 100 mg is the first listed.
NCT01854385 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01854385 about?
NCT01854385 is a clinical study titled "Sumatriptan as Treatment for Post-traumatic Headache". This phase II evaluation of sumatriptan as a treatment for post traumatic headache (PTH) will examine the methods and approach necessary to take the next step to a phase III trial. The sample will include 40 persons with mild complicated, moderate or severe TBI who will be recruited from patients di...
What is the current status of trial NCT01854385?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2013-06. Estimated completion is 2018-02.
What interventions are being tested in trial NCT01854385?
The interventions under investigation include: Sumatriptan 100 mg (DRUG).
Who is sponsoring clinical trial NCT01854385?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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