Eptinezumab for Headache
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests eptinezumab, a treatment for post-traumatic headaches (PTH) following mild head injury. The goal is to determine if a single dose of eptinezumab can reduce headaches and prevent them from becoming chronic. Suitable participants are those who have experienced these headaches for less than 8 weeks and exhibit migraine-like symptoms. As a Phase 3 trial, this treatment is in the final stage before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot use CGRP-related treatments or botulinum toxin for migraines within the last three months. Also, you should not use opioids or barbiturates for headaches more than 4 days a month.
Is there any evidence suggesting that eptinezumab is likely to be safe for humans?
Research has shown that eptinezumab is generally safe for people with headaches. One study reviewed six trials involving over 3,000 participants and found that side effects were no more common than with a placebo. Most side effects, when they occurred, appeared in the first month and were mild. Another study with 344 participants found that side effects occurred in only about 14% of headache cases, and these were mostly mild as well. Overall, people with migraines and similar conditions have tolerated eptinezumab well.12345
Why do researchers think this study treatment might be promising?
Eptinezumab is unique because it targets the calcitonin gene-related peptide (CGRP), a key player in headache pathways, offering a different approach compared to most standard treatments. Unlike oral medications that need to be taken frequently, eptinezumab is administered as a single intravenous infusion, which could mean less frequent dosing and more convenience for patients. Researchers are excited because this method might offer faster relief from post-traumatic headaches, potentially within just eight weeks, providing a promising option for those who don't respond to typical therapies.
What evidence suggests that eptinezumab might be an effective treatment for post-traumatic headaches?
Research has shown that eptinezumab, a medication that blocks the protein CGRP, may reduce the frequency and severity of migraines. In earlier studies, more than half of the patients experienced a significant reduction in the intensity of their migraine attacks after using eptinezumab. Some had fewer than four migraine days each month, and many reported an improved quality of life. For those with chronic migraines, eptinezumab significantly decreased migraine frequency, with up to 70% of patients having their monthly migraine days cut in half or more. In this trial, participants will receive either eptinezumab or a placebo to assess its effectiveness in treating post-traumatic headaches, particularly those resembling migraines.34567
Who Is on the Research Team?
Howard Meng, MD
Principal Investigator
Sunnybrook Health Sciences Centre
Are You a Good Fit for This Trial?
This trial is for individuals who have mild traumatic brain injury (mTBI) and are experiencing post-traumatic headaches with a migraine-like quality. They should be within 8 weeks of their injury to qualify. The study aims to prevent these acute headaches from becoming chronic, which often happens.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single infusion of Eptinezumab 300mg IV or placebo within 8 weeks of post-traumatic headache onset
Follow-up
Participants are monitored for headache frequency, responder rate, and other secondary outcomes
Long-term follow-up
Participants are monitored for adverse events related to study medication
What Are the Treatments Tested in This Trial?
Interventions
- Eptinezumab
Trial Overview
The ELITE-ACT trial is testing whether Eptinezumab, an infusion drug that blocks CGRP and reduces migraines, can help reduce headache burden in patients with mTBI-related headaches when given early on versus a placebo.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Eptinezumab 300mg IV once within 8 weeks of post-traumatic headache onset
Placebo IV once within 8 weeks of post-traumatic headache onset
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sunnybrook Health Sciences Centre
Lead Sponsor
Citations
Early clinical experience with eptinezumab - PubMed Central
After 6 months of preventive treatment with eptinezumab, decreased severity of individual migraine attacks was reported in 17/31 (54.8%) ...
2.
lundbeck.com
lundbeck.com/us/newsroom/2024/lundbeck-to-present-breadth-migraine-cluster-headache-dataLundbeck to Present a Breadth of Migraine and Cluster ...
In addition to reducing headache frequency to less than four monthly headache days in most patients, there was also a reduction in headache severity and related ...
Comprehensive safety analysis of adverse events ...
Migraine significantly impacts quality of life, with eptinezumab emerging as a promising calcitonin gene-related peptide-targeting therapy.
4.
medcentral.com
medcentral.com/neurology/migraine/eptinezumab-shows-promise-for-chronic-cluster-headache-in-open-label-trialEptinezumab Shows Promise for Chronic Cluster ...
The recent 60-week, fixed-dose trial of eptinezumab revealed “a marked reduction in attack frequency and improved quality of life” in ...
5.
thejournalofheadacheandpain.biomedcentral.com
thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-023-01688-wLong-term effectiveness of eptinezumab in patients with ...
During weeks 61–72, 63–70% of patients demonstrated ≥ 50% reduction in MMDs, and 36–45% demonstrated ≥ 75% reduction. Headache severity and ...
Comprehensive safety analysis of adverse events associated ...
Most AEs occurred within the first treatment month. A meta-analysis of six trials (n = 3,148) found no increased overall AE risk versus placebo ...
Efficacy and Safety of Eptinezumab in Episodic Cluster ...
This randomized clinical trial investigates if eptinezumab is efficacious and well tolerated for the treatment of episodic cluster headache.
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