CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Sumatriptan 100 mgdrug
Likely dose
Sumatriptan 100 mgfrom record
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Search/NCT01854385
NCT01854385Phase 2Completed

Sumatriptan as Treatment for Moderate to Severe Post-Traumatic Headache

University of Washington·interventional·Posted May 15, 2013·Updated Jan 11, 2022

In Brief

A Phase 2 clinical trial evaluating Sumatriptan 100 mg for Post-traumatic Headache. Completed, enrolled 40 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 15, 2013
Enrollment StartJun 1, 2013
Primary CompletionFeb 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 13.1 years ago

Interventions

Sumatriptan 100 mgdrug

This is a single-arm, unblinded study of treatment for post-traumatic headache with the open label medication sumatriptan and is being undertaken to test necessary study instruments and procedures, establish feasibility and determine side effects in a population with complicated mild, moderate and severe TBI.