Sumatriptan as Treatment for Post-traumatic Headache
Status:
Completed
Trial end date:
2018-02-01
Target enrollment:
Participant gender:
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.