Treatment of migraine in patients
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study with an Open-Label Period to Evaluate the Efficacy and Safety of Fremanezumab for the Prophylactic Treatment of Migraine in Patients with Inadequate Response to Prior Preventive Treatments
IRAS ID
234380
Contact name
Nicholas Silver
Contact email
Sponsor organisation
Teva Branded Pharmaceutical Products R&D, Inc.
Eudract number
2017-002441-30
Clinicaltrials.gov Identifier
106,533, IND Number
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The purpose of this study is to measure the safety and efficacy of the study medication, fremanezumab, for the prevention of migraines in patients who did not respond to prior migraine preventive treatments.
Migraine is a condition characterised by attacks of headache and other associated symptoms, such as nausea, photophobia (discomfort or pain in the eyes due to normal levels of light) or phonophobia (dislike or intolerance of normal levels of sound). The most common form of migraine is referred to as episodic migraine (EM). However, per year 3% to 6% of individuals with EM evolve to a more disabling condition called chronic migraine (CM) impacting considerably on their quality of life.
During a migraine attack the levels of a protein called Calcitonin gene-related peptide (CGRP) increase, and if this protein is administered via intravenous injection to those who suffer from migraines it causes a migraine-like headache. Inhibition of CGRP activity by blocking of the receptor protein it binds to and activates has been shown to be efficacious in the treatment of migraines.
Teva is developing TEV-48125 (fremanezumab), a type of protein (called an antibody), that inhibits the action of CGRP by blocking its ability to bind to its receptor. Preliminary studies have shown efficacious results for TEVA-48125 in combating migraines.
Approximately 800 CM and EM patients will participate in this research study, male or female aged 18 to 70 years. Their participation will last up to 50 weeks.
The study consists of four periods: (1) screening, (2) double-blind, (3) open-label, and (4) follow-up period.
Participants will be randomly assigned to a treatment group with study medication (2 different dose groups) or placebo. During the open-label period, participants will receive a total of 3 doses over 3 month.
Study visit assessments will include blood sampling, electrocardiograms and completing questionnaires.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0674
Date of REC Opinion
7 Feb 2018
REC opinion
Further Information Favourable Opinion