Clinical Trial Details
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NCT01854385 : Sumatriptan as Treatment for Post-traumatic Headache
PhasePhase 2
AgesMin: 18 Years Max: 65 Years
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

- 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.
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