Status:
COMPLETED
Sumatriptan as Treatment for Post-traumatic Headache
Lead Sponsor:
University of Washington
Conditions:
Post-traumatic Headache
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 inc...
Detailed Description
I. Specific Aims of Study: The ultimate aim of this Phase II open-label study is to test the research methods and approach necessary to successfully carry out a Phase III study for the treatment of po...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01854385
Start Date
June 1 2013
End Date
February 1 2018
Last Update
January 11 2022
Active Locations (2)
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1
Harborview Medical Center
Seattle, Washington, United States, 98104
2
University of Washington Medical Center
Seattle, Washington, United States, 98195