Sumatriptan as Treatment for Post-traumatic Headache
Condition: Post-traumatic Headache
MeSH terms: Post-Traumatic Headache; Headache
Intervention: Sumatriptan 100 mg
Intervention description: 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.
Intervention MeSH terms: Sumatriptan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Post-traumatic headache; Traumatic brain injury; Sumatriptan

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.
    

Eligibility 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 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.