NCT01854385: TWIST

Sumatriptan as Treatment for Moderate to Severe Post-Traumatic Headache

Completed Phase 2 Results posted Last updated 22 December 2021

What this trial tests

Phase 2 trial testing Sumatriptan 100 mg in Post-traumatic Headache in 40 participants. Completed in 1 February 2018.

Timeline

1 June 2013

Primary endpoint
1 February 2018

1 February 2018

Quick facts

Lead sponsor	University of Washington
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 June 2013
Primary completion	1 February 2018
Estimated completion	1 February 2018
Sites	2 locations across United States

Drugs / interventions tested

• Sumatriptan 100 mg — full drug profile →

Conditions studied

• Post-traumatic Headache — all drugs for Post-traumatic Headache →

Sponsor

University of Washington

Who can join

Adults 18 to 65, any sex, with Post-traumatic Headache. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in Headache Relief
  Time frame: 1 month
  percent of headaches that had complete resolution (pain free at 2 hours) for each person, during the initial (pre-intervention) month when they used their regular treatment and during the second of the two months (intervention) when they treated headaches with sumatriptan compared using a mixed-effects regression model. Reported number is the difference in headache resolution from the pre-interven

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current Clinical Trials in Traumatic Brain Injury.
   Ahmed Z. · · 2022 · cited 23× · PMID 35624914 · DOI 10.3390/brainsci12050527
2. Pilot study evaluating treatment with sumatriptan for moderate to severe post-traumatic headache: A phase 2 open-label study.
   Sharma TL, Lucas S, Barber J, Hoffman JM. · · 2024 · PMID 39136260 · DOI 10.1111/head.14807