Clinical Trial: Sumatriptan as Treatment for Post-traumatic Headache

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Sumatriptan as Treatment for Moderate to Severe Post-Traumatic Headache

Brief 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.

Detailed Summary:

I. Specific Aims of Study: The ultimate aim of this Phase II open-label study is to test the research methods and approach necessary to successfully carry out a Phase III study for the treatment of post-traumatic headache (PTH). During this study, we will

1. Determine the feasibility of using a headache diary accessed via smart phone application, the web, or paper/pencil to record accurate headache data in a group of individuals with TBI, and their caregivers as indicated.
2. Evaluate the approximate effect size of sumatriptan on pain severity, duration, and recurrence of headaches in persons with moderate to severe PTH in order to establish the necessary sample size for a Phase III study.
3. Assess the side effect profile of sumatriptan in a brain-injured population as well as the safety of sumatriptan in subjects with TBI.
4. Evaluate the ability of persons with TBI, and their caregivers as indicated, to successfully use abortive headache medications and comply with treatment.
5. Examine the relationship between PTH and cognitive, emotional, and other self-report measures to determine important factors to include in a Phase III study.

This is a single arm, unblinded study enrolling 40 subjects and is being undertaken to test necessary study instruments and procedures, establish feasibility and determine side effects in a population with mild complicated, moderate or severe TBI in preparation for a subsequent Phase III study.

Data collection will occur at enrollment (Clinic Visit 1) at which baseline testing will occur, Day 30 (Clinic Visit 2), and Day 90 (Clinic Visit 3).

percent of headaches that had complete resolution (pain free at 2 hours) for each person, during the initial (pre-intervention) month when they used their regular treatment and during the two months (intervention) when they treated headaches with sumatriptan and compare them using a paired t-test.