Amitriptyline to Prevent Headache After Traumatic Brain Injury
Status:
Completed
Trial end date:
2016-02-01
Target enrollment:
Participant gender:
Summary
The investigators propose to conduct a 2-arm, open-label pilot study to determine if early
treatment with amitriptyline will decrease the frequency and severity of headaches after mild
traumatic brain injury (TBI). Amitriptyline is a tricyclic antidepressant that is commonly
available and inexpensive. It is used as a first-line drug for primary headache prevention in
a very low dose range of 10-50 mg.
- Specific Aim 1 is to conduct a 2-arm open-label study to examine the effect of
preventive treatment with amitriptyline on the frequency and severity of headache after
mild TBI.
- Specific Aim 2 is to collect data needed for design of a Phase 3 study, including an
estimate of effect size, headache variability, and desirable drug treatment start date.
- Specific Aim 3 is to examine the feasibility of using headache diaries with individuals
with mild TBI.
- Specific Aim 4 is to establish the safety and tolerability of amitriptyline for the
prevention of headache after mild TBI.
The investigators hypothesize that early preventive treatment with amitriptyline will avert
the development of chronic post-traumatic headache (PTH) as compared to rates of headache
from a recent natural history study on PTH after mild TBI.
The investigators propose to enroll inpatient subjects from a Level I trauma center as well
as from outpatient clinics and from the general community with a diagnosis of mild TBI.
Subjects will be screened for current headache. After baseline assessment, 72 subjects with
current headache will be randomized to one of 2 groups. Group 1 will immediately begin
amitriptyline and or Group 2 will be followed and begin amitriptyline at Day 30. All subjects
will be asked to complete a daily headache diary beginning on Day 1 of the study. A detailed
medical history and headache survey will be completed. Subjects will have a scheduled stepped
increase in the drug dosage every week for 3 weeks to the maximum study dosage of 50 mg.
Weekly telephone calls will monitor for adverse events and compliance with the drug and
headache diary. Clinic visits will occur at 30, 60 and 90 days. The 30 day clinic visit will
include cognitive testing to assess for differences between groups and initiation of drug
treatment for Group 2. Both 30 and 60 day visits will include review of headache diary,
potential adverse effects, and pill counts. The 90 day visit will be for outcome assessment.
In addition, the headache survey will be repeated by telephone at Day 180.
Phase:
Phase 2
Details
Lead Sponsor:
University of Washington
Treatments:
Amitriptyline Amitriptyline, perphenazine drug combination