This is a United States Department of Defense funded Focused Program study that aims to identify mechanisms and predictors for persistent of post-traumatic headache attributed to mild traumatic brain injury, and identify methods of preventing post-traumatic headache persistence. The objective of the clinical trial component of the Focused Program is to determine whether intervention with erenumab is an effective treatment for PTH attributed to mTBI.
The human studies component of this Focused Program includes clinical phenotyping, neurophysiology, molecular and genetic biomarker discovery, brain imaging, and a clinical trial.These data will be utilized to characterize post-traumatic headache and build univariate and multivariate predictive models for post-traumatic headache persistence and for the response to post-traumatic headache treatment. These studies are described in more detail within a separate clinicaltrials.gov record. The clinical trial is a double-blind, randomized, placebo-controlled investigation of erenumab for the treatment of post-traumatic headache. Participants will be randomized when PTH has been present for 35-56 days. Follow-up questionnaires, headache diary data, pain threshold results, and brain imaging data will be collected longitudinally during the clinical trial to assess for changes over time and associations of such changes with post-traumatic headache treatment outcomes. Due to slow enrollment, the study was later changed to open label since the estimated total enrollment would be inadequate for making comparisons between the placebo and erenumab groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
6
Phoenix VA Health Care System
Phoenix, Arizona, United States
Mayo Clinic
Phoenix, Arizona, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
Change in the Number of Days Experiencing Moderate-to-Severe Headaches
The number of days where subjects experienced moderate-to-severe headaches. This was measured at baseline, 9, 10, 11 and 12 weeks after administration of first dose of erenumab 140 mg or placebo. The change from baseline to week 12 is reported.
Time frame: Baseline, 9, 10, 11 and 12 Weeks, change from baseline to week 12 reported
Responder Rate
The number of patients with at least a 50% reduction in days where they experienced a headache. This was measured at baseline, 9, 10, 11 and 12 weeks after administration of first dose of erenumab 140 mg or placebo. The change from baseline to week 12 is reported.
Time frame: Baseline, 9, 10, 11 and 12 Weeks, change from baseline to week 12 reported
Chronic Headache
The number of patients with a chronic headache, defined as reporting a headache for at least 15 days. This was measured at baseline, 9, 10, 11 and 12 weeks after administration of first dose of erenumab 140 mg or placebo. The change from baseline to week 12 is reported.
Time frame: Baseline, 9, 10, 11 and 12 Weeks, change from baseline to week 12 reported
Change in the Headache Impact Test (HIT-6)
The Headache Impact Test (HIT-6) measures the impact of headaches on a person's daily life. It assesses the frequency and severity of headaches, their functional limitations and the impact on daily activities such as work, education and social interactions. The HIT-6 test has 6 questions. Each of the six questions receives a score from 6-13. The final HIT-6 score can range from 36 to 78. A higher score indicates more disability due to headache. This was measured at baseline, 9, 10, 11 and 12 weeks after administration of first dose of erenumab 140 mg or placebo. The change from baseline to week 12 is reported.
Time frame: Baseline, 9, 10, 11 and 12 Weeks, change from baseline to week 12 reported
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Mayo Clinic
Rochester, Minnesota, United States
Change in the Number of Days Where Acute Treatment Was Administered to Relieve a Headache
The change in the number of days where subjects underwent acute treatment to relieve a headache. Treatment days were days in which subjects took analgesic, triptan, or ergotamine containing medication, or they underwent device neuromodulation \[e.g. vagal or trigeminal nerve electrical stimulation or single pulse transcranial magnetic stimulation\]. This was measured at baseline,9, 10, 11 and 12 weeks after administration of first dose of erenumab 140mg or placebo. The change from baseline to 12 weeks is reported.
Time frame: Baseline, 9, 10, 11 and 12 Weeks, change from baseline to week 12 reported