Sumatriptan as Treatment for Post-traumatic Headache (TWIST)
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 Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Sumatriptan as Treatment for Moderate to Severe Post-Traumatic Headache|
- Headache relief [ Time Frame: 2 months ] [ Designated as safety issue: No ]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.
- Adverse events [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]The investigators will calculate the percent who stopped taking sumatriptan because of side effects, percent who experienced each adverse event.
- Compliance [ Time Frame: 3 months ] [ Designated as safety issue: No ]The investigators will calculate the percent of subjects who used the diary successfully and percent who were able to maintain compliance with treatment.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
Open label study of sumatriptan to treat post-traumatic headache. Subjects will use sumatriptan 100 mg at the onset of headache pain and may repeat the dose if not pain-free in 2 hours. Subjects will receive a maximum of 18 pills for use over two months. Subjects will maintain a daily headache diary.
Drug: Sumatriptan 100 mg
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01854385
|Contact: Leslie Kempthorne, BSemail@example.com|
|United States, Washington|
|Harborview Medical Center||Recruiting|
|Seattle, Washington, United States, 98104|
|Contact: Leslie Kempthorne firstname.lastname@example.org|
|University of Washington Medical Center||Recruiting|
|Seattle, Washington, United States, 98195|
|Contact: Leslie Kempthorne, BS 206-543-0219 email@example.com|
|Principal Investigator: Jeanne M Hoffman, PhD|
|Sub-Investigator: Sylvia Lucas, MD, PhD|
|Sub-Investigator: Nancy Temkin, PhD|
|Sub-Investigator: Sureyya Dikmen, PhD|
|Principal Investigator:||Jeanne M Hoffman, PhD||University of Washington|
|Study Director:||Leslie Kempthorne||University of Washington|