Amitriptyline to Prevent Headache After Traumatic Brain Injury

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

February 29, 2016

Study Completion Date

February 29, 2016

Conditions
Brain InjuriesPost-Traumatic Headache
Interventions
DRUG

Amitriptyline

Participants with headache will be enrolled within the first 12 weeks after injury and will be randomly assigned to 2 groups (see Table 1 for summary of protocol). Group 1 will be assessed within 3 months of injury (baseline, Day 0) (when they will receive their initial ramp-up dosage containers; see Table 2 for dosing), Day 30 and Day 60 (to monitor compliance and distribute study drug), and for final outcome on Day 90. Group 2 will be assessed within 3 months of injury (baseline, Day 0) but will not receive medication until their Day 30 visit. Those in group 2 who report headache at Day 30 will receive their initial dosage container and will then be reassessed at Day 60 (to monitor compliance and distribute study drug) and Day 90 (final outcome).

Trial Locations (1)

98109

Harborview Medical Center, Seattle

All Listed Sponsors
lead

University of Washington

OTHER

NCT01856270 - Amitriptyline to Prevent Headache After Traumatic Brain Injury | Biotech Hunter | Biotech Hunter