Fremanezumab for Preventative Treatment of Migraine in Patients with MDD
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Followed by an Open-Label Extension to Evaluate the Efficacy and Safety of Fremanezumab for Preventative Treatment of Migraine in Patients with Major Depressive Disorder
IRAS ID
271348
Contact name
Giorgio Lambru
Contact email
Sponsor organisation
Teva Branded Pharmaceutical Products R&D, Inc.
Eudract number
2019-001989-15
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND Number, 106533 ; BLA Number, 761089
Duration of Study in the UK
1 years, 7 months, 2 days
Research summary
Migraine is ranked as one of the most disabling condition worldwide. Individuals who suffer with migraine have recurrent attacks of headache, which are moderate to severe in pain intensity as often associated with nausea/vomiting, sensitivity to lights, sounds and movements. Migraine is classified on the basis of the number of headache days/month in episodic (<15 headache days/month) and chronic (15 or more headache days/month). Depression is significantly more common in people with migraine than in healthy individuals, and those with Chronic Migraines are almost twice as likely to receive a diagnosis of depression. Migraine symptoms also seem more difficult to treat in people with depression.
Fremanezumab is a type of protein (called an antibody) that selectively binds the calcitonin gene-related peptide (CGRP) ligand and blocks it from binding to the CGRP receptor. CGRP levels have been shown to increase significantly during migraine and return to normal with headache relief. The purpose of the study is to evaluate the effectiveness of fremanezumab in reducing the number of monthly migraine days and to see there is a secondary effect in the improvement of MDD symptoms in patients with migraine and MDD.
Participation will last 28 weeks and consists of : (1) screening period, (2) double-blind period, (3) open-label period (4) follow-up period.
During the double blind period participants will receive an injection of either 225 mg of frezmanezumab or placebo once a month for 3 months. Neither the participants nor the study doctor will know which treatment the participants will receive. Participants who complete the 3 month treatment period can enter the open label period, where they will receive 675 mg (3 injections of 225 mg) of frezmanezumab once.
Participants will have up to 6 study visits including study assessments, which include physical exams, electrocardiograms and questionnaires.
REC name
London - Chelsea Research Ethics Committee
REC reference
20/LO/0129
Date of REC Opinion
19 May 2020
REC opinion
Further Information Favourable Opinion