Clinical Trial Details
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NCT01856270 : Amitriptyline to Prevent Headache After Traumatic Brain Injury
PhasePhase 2
AgesMin: 18 Years Max: 60 Years
Inclusion Criteria:

- Acute mild TBI (Glasgow Coma Scale of 13-15 on emergency department evaluation, any
period of loss of consciousness (LOC) < than 30 minutes, alteration of consciousness
or post-traumatic amnesia (not to exceed 24 hours)

- Ability to give consent

- Ages 18-60

- Access to a telephone

- Current headache (new headache or headache worse than prior to injury)

Exclusion Criteria:

- Does not speak English

- Diagnosed seizure disorder

- Myocardial infarction in prior 6 months

- Cardiac arrhythmia requiring medication treatment

- Prolonged Q-T interval on electrocardiogram

- Psychosis

- Intoxication on hospital admission sufficient enough to cloud the diagnosis of mild

- Incarceration or homelessness

- Allergy to amitriptyline

- Current treatment with amitriptyline or other tricyclic antidepressant

- Currently taking any medication not recommended for use with amitriptyline due to the
potential for Q-T interval prolongation. Examples of this include: Class I, I-A or
II antiarrhythmics, TCA's, MAOI's, selected fluoroquinolones (gatifloxacin,
moxifloxacin), selected antipsychotic medications (haloperidol, risperidone,
quetiapine), selected antiretroviral medications, cisapride, chloroquine,
chlorpromazine, prochlorperazine, promethazine, citalopram, fluoxetine, erythromycin,

- History of glaucoma

- History of prostate disease or current urinary retention
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