Sumatriptan as Treatment for Post-traumatic Headache (TWIST)
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|ClinicalTrials.gov Identifier: NCT01854385|
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : March 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Post-traumatic Headache||Drug: Sumatriptan 100 mg||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sumatriptan as Treatment for Moderate to Severe Post-Traumatic Headache|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||February 2018|
|Actual Study Completion Date :||February 2018|
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
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.
- Headache relief [ Time Frame: 2 months ]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 ]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 ]The investigators will calculate the percent of subjects who used the diary successfully and percent who were able to maintain compliance with treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854385
|United States, Washington|
|Harborview Medical Center|
|Seattle, Washington, United States, 98104|
|University of Washington Medical Center|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Jeanne M Hoffman, PhD||University of Washington|
|Study Director:||Leslie Kempthorne||University of Washington|