CAMG334A2301 in episodic migraine phase 3b
Research type
Research Study
Full title
A 12-week double-blind, randomised, multicentre study comparing the efficacy and safety of once monthly subcutaneous 140mg AMG334 against placebo in adult episodic migraine patients who have failed 2-4 prophylactic migraine treatments
IRAS ID
211113
Contact name
Brendan Davies
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2016-002211-18
Duration of Study in the UK
2 years, 2 months, 0 days
Research summary
Migraine is one of the most common neurological disorders globally, characterised by recurrent headaches lasting 4-72 hours and usually accompanied by other neurological disturbances: nausea, vomiting, and other nonspecific symptoms. Patient burden, disability and social impact increase with higher attack frequency. Migraines are classed according to frequency of migraines per month. Patients with 4-14 migraine days per month are classed as having ’Episodic Migraine’ (EM) which this study is researching.
Current treatment for Migraine treatment vary , many used off-label and often based on insufficient or limited evidence. All therapies are commonly associated with variable effectiveness or tolerability issues leading to patient treatment discontinuation.
AMG334 works to block a protein called Calcitonin Gene-related Peptide (CGRP) by stopping it from attaching to the nerve cells receptors. CGRP is found in elevated levels in the nervous system of migraine patients during attacks. CGRP attaching to its’ receptor on nerve cells results in dilation of the brain’s blood vessel and inflammation of the brain’s tissue. This is known to be involved in causing migraine symptoms.
This study aims to see if AMG334 is safe and effective in patients who have failed 2-4 previous migraine treatments. Effectiveness is measured by reviewing reduction in migraine days and improving patient quality of life.Patients giving consent and meeting inclusion criteria will undergo examinations to determine eligibility. Patients entering the study have a 50% chance of receiving either 70mg AMG334 or placebo (no active study drug). The study is double-blind for the first 12 weeks. After the first 12 weeks patients can choose to remain in the open label period of the study for a further 1 year during which they will receive AMG334.
382 patients will be treated as part of this study, approximately 23 from the UK. This study is being run by Novartis Pharma AG.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
16/EM/0386
Date of REC Opinion
11 Oct 2016
REC opinion
Further Information Favourable Opinion