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Sumatriptan as Treatment for Post-traumatic Headache (TWIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01854385
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : March 27, 2018
Information provided by (Responsible Party):
Jeanne Hoffman, University of Washington

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.

Condition or disease Intervention/treatment Phase
Post-traumatic Headache Drug: Sumatriptan 100 mg Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
Drug Information available for: Sumatriptan

Arm Intervention/treatment
Experimental: Sumatriptan
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.
Other Names:
  • Imitrex
  • Imigran

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18-65. The lower age limit is set for ability to consent as an adult for research participation as well as being a minimum age for administration of most validated outcome measurements. The higher age limit is set to 65 to reduce likelihood of health issues which may be a contraindication to the use of sumatriptan and to meet recommendations by the International Headache Society.62
  • Diagnosis of TBI occurring at least 3 months but not greater than 60 months before enrollment. Three months was chosen to include only those subjects who are having headache beyond their acute injury and 60 months to identify the ability of individuals with TBI and headache to use both a headache diary and the medication.
  • Subject has at least four and up to a maximum of fifteen total headache days per month. Subject report of meeting this criteria will result in the subject entering the first month of the study. However, this frequency must be documented in headache diary to enter the treatment phase of the study.
  • Headaches are classified as moderate to severe (2 or 3 on the 4 point pain scale: 0=no headache, 1=mild headache, 2=moderate headache, 3=severe headache). As above, headache severity must be documented in the month-long headache diary prior to entry into the treatment phase.
  • Subject is able and willing to give written informed consent for participation in screening activities and to participate fully in the study if eligible. For those subjects who score below 25 on the Mini Mental Status Examination, there must be a caregiver willing to also be consented for participation in the study.
  • Female subjects of childbearing potential must have a negative pregnancy test at enrollment, and agree to remain abstinent or use acceptable methods of birth control (i.e., hormonal contraceptives, intrauterine device, diaphragm with spermicide, cervical cap or sponge, condoms, or partner has had a vasectomy). Sumatriptan has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of decreased fetal body weight, embryo lethality, and cervicothoracic vascular defects. There are no controlled data in human pregnancy and therefore, sumatriptan should only be given during pregnancy when benefit outweighs risk.

Exclusion Criteria:

  • History of ischemic heart disease (angina pectoris, history of myocardial infarction, silent ischemia, Prinzmetal's angina/coronary vasospasm, ischemic bowel disease, or peripheral vascular disease) based on self-report or history of basilar or hemiplegic migraine.
  • Uncontrolled hypertension at initial visit (sitting systolic pressure > 140 mm Hg, diastolic pressure > 90 mm Hg).
  • Impaired renal or liver function by medical history.
  • Subject has taken an MAO inhibitor within 2 weeks of screening because these drugs and sumatriptan use the same metabolic pathway.
  • Subject has hypersensitivity reactions or other intolerance to sumatriptan or any other 5-HT 1B/1D-receptor agonists.
  • If subjects have medication overuse headache in the opinion of the investigator (if using medication to treat acute headache on more than 15 days per month).
  • Inability to speak or read English which would limit ability to interact with examiners and complete headache diary and other questionnaires during this study.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01854385

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United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
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Principal Investigator: Jeanne M Hoffman, PhD University of Washington
Study Director: Leslie Kempthorne University of Washington

Additional Information:
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Responsible Party: Jeanne Hoffman, Professor- Rehabilitative Medicine: Psychology, University of Washington Identifier: NCT01854385     History of Changes
Other Study ID Numbers: 44912
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jeanne Hoffman, University of Washington:
Post-traumatic headache
Traumatic brain injury

Additional relevant MeSH terms:
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Post-Traumatic Headache
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs