Trial Summary
What is the purpose of this trial?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.
Is the drug Erenumab a promising treatment for post-traumatic headache?The provided research articles do not contain information about Erenumab or its effectiveness for post-traumatic headache. Therefore, we cannot determine if Erenumab is a promising treatment based on this information.123611
What safety data is available for Erenumab?Erenumab, also known as Aimovig, has been evaluated for safety and tolerability in multiple studies for migraine prevention. The most common adverse events reported are local skin reactions and constipation. No severe adverse events or frequent discontinuations due to adverse events were detected, indicating a well-tolerated safety profile. These findings are consistent across phase 2, phase 3, open-label, and observational studies.458910
What data supports the idea that Erenumab for Post-Traumatic Headache is an effective drug?The available research shows that Erenumab is effective in reducing the frequency of migraines, as it was developed specifically for migraine prevention. It has been shown to work well even for patients who did not respond to other treatments. However, the research provided focuses on its use for migraines, not specifically for post-traumatic headaches.4571213
Do I need to stop my current medications to join the trial?The trial protocol does not specify if you need to stop your current medications. However, if you started or changed the dose of a headache preventive medication within 3 months prior to screening, you may not be eligible. It's best to discuss your specific medications with the trial team.
Eligibility Criteria
Adults aged 18-70 with post-traumatic headache (PTH) due to mild traumatic brain injury, who have had PTH for 7-56 days and experienced an increase in moderate or severe headache days. Participants must be able to keep a headache diary and comply with study visits. Excluded are those with certain chronic headaches, recent use of specific treatments or preventive medications, unstable medical conditions, major psychiatric disorders, or women not using reliable contraception.Inclusion Criteria
I am between 18 and 70 years old.
I have been diagnosed with acute post-traumatic headache due to a mild head injury.
I've had 5 or more bad headache days recently, which is an increase from before.
Exclusion Criteria
I've had an average of 4 headache days a month for the last 6 months.
I've had chronic headaches for more than 3 months before my brain injury.
I have been treated with a CGRP-targeted monoclonal antibody before.
Treatment Details
The trial is testing Erenumab against a placebo to see if it can effectively treat persistent headaches that develop after a mild traumatic brain injury. Participants will be randomly assigned to receive either the medication or placebo as part of the study's efforts to understand and prevent long-term PTH.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ErenumabExperimental Treatment1 Intervention
140 mg erenumab
Group II: PlaceboPlacebo Group1 Intervention
placebo comparator
Erenumab is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Aimovig for:
- Prevention of migraine in adults
🇪🇺 Approved in European Union as Aimovig for:
- Prevention of migraine in adults
Find a clinic near you
Research locations nearbySelect from list below to view details:
Mayo ClinicJacksonville, FL
Phoenix VA Health Care SystemPhoenix, AZ
Mayo ClinicPhoenix, AZ
Mayo Clinic in ArizonaScottsdale, AZ
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
AmgenIndustry Sponsor
United States Department of DefenseCollaborator
Arizona State UniversityCollaborator
Phoenix VA Health Care SystemCollaborator
University of ArizonaCollaborator
Translational Genomics Research InstituteCollaborator
References
[Enoxaparin for the Treatment of Unstable Angina and Non-ST Segment Elevation Myocardial Infarction: the ENO-INT Study]. [2018]AIM. To assess safety and efficacy of enoxaparin in patients with UA/NSTEMI in an open-label, multi-centre, non-comparative study and to compare the results with data from large-scale randomized trials ESSENCE and TIMI-11B.
Does enoxaparin interfere with HMGB1 signaling after TBI? A potential mechanism for reduced cerebral edema and neurologic recovery. [2022]Enoxaparin (ENX) has been shown to reduce cerebral edema and improve neurologic recovery after traumatic brain injury (TBI), through blunting of cerebral leukocyte (LEU) recruitment. High mobility group box 1 (HMGB1) protein may induce inflammation through LEU activation. We hypothesized that ENX after TBI reduces LEU-mediated edema through blockade of HMGB1 signaling.
A Systematic Review of the Risks and Benefits of Venous Thromboembolism Prophylaxis in Traumatic Brain Injury. [2019]Patients suffering from traumatic brain injury (TBI) are at increased risk of venous thromboembolism (VTE). However, initiation of pharmacological venous thromboprophylaxis (VTEp) may cause further intracranial hemorrhage. We reviewed the literature to determine the postinjury time interval at which VTEp can be administered without risk of TBI evolution and hematoma expansion.
Erenumab: First Global Approval. [2019]Amgen and Novartis are developing erenumab (AIMOVIG™, erenumab-aooe)-a fully human monoclonal antibody calcitonin gene-related peptide (CGRP) receptor antagonist-for the prevention of migraine. CGRP is a vasodilatory neuropeptide implicated in the pathophysiology of migraine and treatment with erenumab was associated with significant reductions in migraine frequency in phase II and III clinical trials. Based on these positive results erenumab was recently approved in the US for the preventive treatment of migraine in adults and has received a positive opinion in the EU for the prophylaxis of migraines in adults who have at least 4 migraine days per month. This article summarizes the milestones in the development of erenumab leading to this first approval.
Aimovig for Migraine Prevention: The New Kid May Have Trouble Fitting in. [2019]Aimovig (erenumab-aooe), codeveloped by Amgen and Novartis, has been recently approved for the prevention of migraines. Its mechanism of action is different than other migraine medications. But perhaps more interestingly, it is the first drug recently developed specifically for migraine prevention.
The impact of enoxaparin administration in relationship to hemorrhage in mild traumatic brain injury. [2019]Venous thromboembolism prophylaxis in the general trauma population is well established. However, risk of increased intracranial hemorrhage in traumatic brain injury (TBI) population is of concern. The aim for this study is to identify a reproducible model of mild traumatic brain injury (mTBI), evaluated by clinical and histological markers and test the hypothesis that enoxaparin increases the risk of spontaneous brain hemorrhage.
Efficacy and tolerability of erenumab in patients with episodic migraine in whom two-to-four previous preventive treatments were unsuccessful: a randomised, double-blind, placebo-controlled, phase 3b study. [2022]A substantial proportion of patients with migraine does not respond to, or cannot tolerate, oral preventive treatments. Erenumab is a novel CGRP-receptor antibody with preventive efficacy in migraine. We assessed its efficacy and tolerability in patients with episodic migraine in whom previous treatment with two-to-four migraine preventives had been unsuccessful.
A Randomized Phase 2 Study of Erenumab for the Prevention of Episodic Migraine in Japanese Adults. [2020]A phase 2, double-blind, placebo-controlled study to evaluate the efficacy and safety of erenumab for the prevention of episodic migraine in Japanese patients was conducted.
Patient Reported Ease-of-Use with a Disposable Autoinjector in Individuals with Migraine. [2022]Label="PURPOSE" NlmCategory="OBJECTIVE">Erenumab-aooe (erenumab, Aimovig®)-a fully human monoclonal antibody that inhibits the calcitonin gene-related peptide (CGRP) receptor-is approved for the prevention of migraine in adults in a number of countries. The approved monthly dosage of erenumab (70 and/or 140 mg, depending on the country) is available as a single, prefilled autoinjector for subcutaneous administration in most countries where it is approved. This study evaluated the patient-reported ease-of-use, ability to learn self-injection, confidence in performing a simulated self-injection, and ergonomics of a prefilled autoinjector device for erenumab (SureClick® autoinjector) in individuals in the US with migraine.
Safety and tolerability evaluation of erenumab for the preventive treatment of migraine. [2021]Introduction: Erenumab, a monoclonal antibody targeting the receptor of calcitonin gene related peptide (CGRP), is the first disease-specific and mechanism-based treatment approved for the prevention of migraine. Although the safety and tolerability data from randomized trials are clear, the physiological effects of CGRP rise reasonable concerns. We aimed to evaluate the current evidence for safety and tolerability related to erenumab use in migraine. Areas covered: This review outlines the severe adverse events (AEs), common AEs, AEs leading to treatment discontinuation and AEs of special interest, reported in all phase 2, phase 3, open label, and observational studies with erenumab in migraine. Individual safety reports were also included in the systematic review of evidence. Expert opinion: No safety and tolerability flags were detected in this review. The most common AE are local skin reactions and constipation. No severe AEs, or frequent AEs leading to treatment discontinuation were detected. Treatment is well tolerated. The only AE of interest that may play a role in decision making and treatment monitoring is constipation. These findings are in line with previous safety reports, further highlighting the substantial tolerability and safety profile of the modern anti-CGRP monoclonal antibodies for the prevention of migraine.
Venous thromboembolic pharmacological prophylaxis in severe traumatic acute subdural hematomas: Early prophylaxis is effective and safe. [2022]The purpose of this study was to evaluate the optimal timing and type of pharmacological venous thromboembolism prophylaxis (VTEp) in patients with severe blunt head trauma with acute subdural hematomas (ASDH).
Reduction in migraine pain intensity in patients treated with erenumab: A post hoc analysis of two pivotal randomized studies. [2022]Erenumab (erenumab-aooe in the US) effectively reduces monthly migraine days in episodic and chronic migraine. This traditional outcome does not capture the intensity of headache pain on days with migraine.
Erenumab efficacy in migraine headache prophylaxis: A systematic review. [2023]This systematic review aims to show the efficiency of Erenumab in the preventive therapy of episodic and chronic migraine, which is still under research.