Overseen BySait Ashina, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Beth Israel Deaconess Medical Center
No Placebo Group
Prior Safety Data
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?The main goal of this study is to determine whether there is a relationship between fremanezumab's ability to prevent migraine and improved sleep quality in migraine patients (fremanezumab is a FDA-approved humanized CGRP monoclonal antibody for the treatment of migraine).
This is a within-person study design that examines treatment effects (changes) using high-resolution assessments. To complete the study, each participant will be observed using daily assessments of migraine and sleep outcomes before treatment (baseline: 0 to 30 days), and at 1, 2, and 3 months after treatment (injection 1: days 31-60, injection 2: days 61-90, injection 3: days 91-120). In essence, this creates an interrupted time-series design where repeated interventions are introduced at fixed intervals.
Will I have to stop taking my current medications?
The trial requires that you do not start or change the type, dosage, or frequency of any preventive medications for conditions other than migraine that might affect the study, such as antidepressants or beta-blockers. If you are currently on a migraine preventative therapy, you cannot participate in the trial.
How is the drug fremanezumab different from other migraine treatments?
Fremanezumab is unique because it is a fully humanized monoclonal antibody that specifically targets the calcitonin gene-related peptide (CGRP), which plays a key role in migraines. It is administered as a subcutaneous injection with flexible dosing options, either monthly or quarterly, making it convenient for patients.
234712Eligibility Criteria
Adults aged 18-65 with migraines, experiencing 10-25 headache days a month, at least 8 being migraine days lasting over 4 hours if untreated. Must score β₯10 on the Insomnia Severity Index but not have severe sleep disorders like obstructive sleep apnea or restless legs syndrome. Cannot be using certain pain or sleep medications regularly, have serious heart/cerebrovascular conditions, history of substance abuse within last 5 years, or be pregnant/nursing without birth control.Inclusion Criteria
I have been diagnosed with migraine, following official guidelines.
I am between 18 and 65 years old.
I have been diagnosed with migraine, following specific guidelines.
I have 10-25 headache days a month, with at least 8 being long-lasting migraines.
My migraines started when I was 50 or younger.
Exclusion Criteria
I am currently taking prescription pain medication for headaches or body pain.
I have had a stroke, TIA, or surgery on the arteries in my neck.
I have a history of or suspect I have secondary headaches.
I have used marijuana or CBD oil in the past year.
I use medication to help me sleep every day.
I have been diagnosed with obstructive sleep apnea or restless legs syndrome.
I am currently taking medication to prevent migraines.
I do not have other major pain issues that could affect the study's results.
I do not have severe heart problems like heart failure or a past heart attack.
I regularly take painkillers or specific headache medicines more than half the month.
Participant Groups
The trial is testing Fremanezumab's effect on preventing migraines and improving sleep quality in patients with frequent migraines. Participants will self-report daily assessments of migraine and sleep before treatment and for three months after starting treatment to see if there are changes in their condition.
1Treatment groups
Experimental Treatment
Group I: treatment effectExperimental Treatment1 Intervention
No 2 arms and only 1 intervention
Fremanezumab is already approved in United States, European Union, United Kingdom for the following indications:
πΊπΈ Approved in United States as Ajovy for:
- Prevention of migraines in adults
πͺπΊ Approved in European Union as Ajovy for:
- Prevention of migraines in adults
π¬π§ Approved in United Kingdom as Ajovy for:
- Prevention of migraines in adults
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
BIDMC Headaceh ClinicBoston, MA
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Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
Teva Pharmaceuticals USAIndustry Sponsor
References
Current evidence of temozolomide and bevacizumab in treatment of gliomas. [2022]This review article summarizes in vitro, in vivo, and clinical evidence pertaining to temozolomide (TMZ) and bevacizumab (BEV) efficacy and mechanism of action in gliomas.
Fremanezumab as Add-On Treatment for Patients Treated With Other Migraine Preventive Medicines. [2022]Fremanezumab (formerly TEV-48125) is a monoclonal antibody directed against calcitonin-gene-related peptide (CGRP), a validated target for migraine preventive therapy. In two previous phase 2 studies, fremanezumab administered once every 28 days for 12 weeks was found to be effective and safe as a preventive treatment for patients suffering from episodic migraine (EM) and chronic migraine (CM).
Fremanezumab blocks CGRP induced dilatation in human cerebral, middle meningeal and abdominal arteries. [2019]Fremanezumab (TEV-48125) is a fully humanized anti-calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) that has shown positive results in the prevention of episodic migraine and chronic migraine. Previous preclinical studies have revealed CGRP antagonistic effects on intracranial arteries (ICA). The aim of the study was to evaluate the in vitro antagonistic effects of fremanezumab on human arteries.
Fremanezumab: First Global Approval. [2019]Fremanezumab-vfrm (hereafter referred to as fremanezumab) [AJOVYβ’] is a fully humanized monoclonal antibody (IgG2Ξa) developed by Teva Pharmaceuticals to selectively target calcitonin gene-related peptide (a vasodilatory neuropeptide involved in the pathophysiology of migraine). Its use has been associated with significant reductions in migraine frequency, the requirement for acute headache medication use and headache-related disability compared with placebo in multinational, phase III studies, and in September 2018 fremanezumab was approved by the US FDA for the preventive treatment of migraine in adults. A regulatory assessment for fremanezumab as a preventive treatment of migraine in adults is underway in the EU. Fremanezumab is also undergoing phase III development for the preventive treatment of cluster headache (although a phase III chronic cluster headache study has been suspended due to the results of a prespecified futility analysis) and phase II development for the preventive treatment of post-traumatic headache disorder. This article summarizes the milestones in the development of fremanezumab leading to this first approval in the USA for the preventive treatment of migraine in adults.
Safety and Tolerability of Fremanezumab for the Prevention of Migraine: A Pooled Analysis of Phases 2b and 3 Clinical Trials. [2020]Presentation of pooled analysis of safety data for fremanezumab in patients with chronic (CM) or episodic migraine (EM) from 4 placebo-controlled phase 2b and phase 3 studies.
Efficacy and safety of fremanezumab for chronic migraine prevention: Multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in Japanese and Korean patients. [2022]To determine the efficacy and safety of fremanezumab administration in Japanese and Korean patients with chronic migraine (CM).
Fremanezumab autoinjector pen for the prevention of migraine. [2022]Ajovy (fremanezumab, Teva Pharmaceuticals, Israel) is a fully humanized monoclonal antibody that selectively binds both isoforms of the calcitonin gene-related peptide. Calcitonin gene-related peptide is a 37-amino acid neuropeptide involved in central and peripheral pathophysiological events in migraine. It is indicated for prophylaxis of migraine in adults who have at least four migraine days per month, and can be administered as a subcutaneous injection using an autoinjector device, with two dosing options: 225 mg once a month or 675 mg quarterly. In this article, I present data from Phase III clinical trials of fremanezumab in episodic and chronic migraine, in which fremanezumab demonstrated efficacy and had a favorable tolerability profile, with no serious treatment-related adverse events.
Sustained response to bevacizumab in a patient with mosaic neurofibromatosis type 2 carrying the NF2:c.784C>T p.(Arg262*) variant. [2022]Neurofibromatosis type 2 (NF2) is a tumor predisposition syndrome characterized by the growth of schwannomas, especially bilateral vestibular schwannomas (VS), meningiomas, and ependymomas. The anti-VEGF antibody bevacizumab has shown efficacy for VS in some NF2 patients. However, there is limited data on the effect of bevacizumab on non-vestibular tumors, and on the correlation between therapy response and genotype. Here, we report on a 33-year-old patient with bilateral VS, 14 additional intracranial or spinal schwannomas, and a meningioma treated with bevacizumab, off-label in the European Union, for 2 years. The genotype of the patient was determined by mutational analysis of NF2, SMARCB1, and LZTR1 on DNA of multiple tissues. Additionally, we performed volumetric measurements of quantifiable non-vestibular tumors (n = 8) on MRI scans from 5 pre-therapeutic and 2 therapeutic years, and pure-tone audiometry of the non-deaf ear. A heterozygous NM_000268.3(NF2):c.784C>T p.(Arg262*) variant was identified in DNA from 3 schwannomas, but not in leukocyte or oral mucosa DNA, and no rare SMARCB1/LZTR1 variants were detected, establishing the diagnosis of definite NF2 mosaicism. While schwannomas had progressed with a mean annual growth rate of 38% pre-therapeutically, volume stabilization or reduction of all schwannomas along with improvement of pain and neurological deficits, including hearing impairment, were observed under 24 months of bevacizumab. In summary, this is the first report of a sustained response to bevacizumab in a patient shown to carry the frequent mosaic NF2:c.784C>T p.(Arg262*) variant. Our results may be of particular relevance to guide treatment decisions in mosaic NF2 patients harboring this variant.
Review of Tolerability of Fremanezumab for Episodic and Chronic Migraine. [2023]Calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) were the first class of medication specifically developed for the prevention of migraine. Fremanezumab is one of four CGRP mAbs currently available and is approved by the US Food and Drug Administration (FDA) for the preventative treatment of episodic and chronic migraines. This narrative review summarizes the history of fremanezumab development, the trials that led to its approval, and the later studies published evaluating its tolerability and efficacy. Evidence of fremanezumab for clinically significant efficacy and tolerability in patients with chronic migraine is especially important when considering the high level of disability, lower quality of life scores, and higher levels of health-care utilization associated with this condition. Multiple clinical trials demonstrated superiority of fremanezumab over placebo in terms of efficacy while demonstrating good tolerability. Treatment-related adverse reactions did not differ significantly compared to placebo and dropout rates were minimal. The most commonly observed treatment-related adverse reaction was mild-to-moderate injection site reaction, described as erythema, pain, induration, or swelling at the injection site.
Efficacy and safety of bevacizumab, irinotecan, and temozolomide combination for relapsed or refractory pediatric central nervous system embryonal tumor: a single-institution study. [2023]This study aimed to evaluate the efficacy and safety of combination therapy with bevacizumab (Bev), irinotecan (CPT-11), and temozolomide (TMZ) in children with central nervous system (CNS) embryonal tumor relapse.
Early and sustained efficacy of fremanezumab over 24-weeks in migraine patients with multiple preventive treatment failures: the multicenter, prospective, real-life FRIEND2 study. [2023]To verify the long-term (24-week) efficacy, safety, and tolerability of fremanezumab in real-life patients with high-frequency episodic migraine (HFEM: β₯ 8 days/month) or chronic migraine (CM: β₯ 15 days/month), and multiple preventive treatment failures.
Delayed Injection Site Reaction to Fremanezumab for Chronic Migraine Treatment. [2023]Fremanezumab is a humanized monoclonal antibody administered through a subcutaneous injection. It is used for treatment of migraines, and occasional injection site reactions have developed after usage.
A head-to-head observational cohort study on the efficacy and safety of monoclonal antibodies against calcitonin gene-related peptide for chronic and episodic migraine. [2023]To compare the effectiveness and safety of galcanezumab, fremanezumab, and erenumab for the treatment of chronic and episodic migraine, through real-world data.