Sumatriptan as Treatment for Post-traumatic Headache (TWIST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Washington
Sponsor:
Information provided by (Responsible Party):
Kathleen Bell, University of Washington
ClinicalTrials.gov Identifier:
NCT01854385
First received: May 10, 2013
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Post-traumatic Headache
Drug: Sumatriptan 100 mg
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
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)
Arms Assigned Interventions
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
Other Names:
  • Imitrex
  • Imigran

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 24 months before enrollment. Three months was chosen to include only those subjects who are having headache beyond their acute injury and 24 months was chosen from our natural history study to ensure that the headache may reasonably be connected to the TBI.
  • 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 obtains a score of 25 or greater on the Mini Mental Status Examination or has a caregiver to monitor implementation of study procedures including the headache diary and medication regimen.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01854385

Contacts
Contact: Kimberly Glorieux, B.S. 206 543-4952 kimg@uw.edu
Contact: Leslie Kempthorne, B.S. 206 543-0219 ette@uw.edu

Locations
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Leslie Kempthorne       ette@uw.edu   
Contact: Kimberly Glorieux       kimg@uw.edu   
University of Washington Medical Center Not yet recruiting
Seattle, Washington, United States, 98195
Contact: Kimberly Glorieux       kimg@uw.edu   
Contact: Leslie Kempthorne       ette@uw.edu   
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Kathleen R Bell, M.D. University of Washington
  More Information

Additional Information:
No publications provided

Responsible Party: Kathleen Bell, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01854385     History of Changes
Other Study ID Numbers: 44912-B
Study First Received: May 10, 2013
Last Updated: June 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Post-traumatic headache
Traumatic brain injury
Sumatriptan

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

ClinicalTrials.gov processed this record on September 22, 2014