CAMG334A3301 BECOME - Migraine Impact data collection study
Research type
Research Study
Full title
The Burden of migraine in specialist headache centres treating patients with prophylactic treatment failure.
IRAS ID
233968
Contact name
Fayyaz Ahmed
Contact email
Sponsor organisation
Novartis Pharma AG
Duration of Study in the UK
0 years, 3 months, days
Research summary
Novartis is conducting this non-interventional study called BECOME to assess the proportion of episodic and chronic migraine patients who have failed at least one standard of care prophylactic migraine treatment. The aim of this study is to assess the burden of migraine on people’s quality of life and the impact of migraine on healthcare resources. The study is designed to measure the number of headache patients across headache specialist care centers who have failed at least one prophylactic migraine treatment and to describe the impact of migraine on this population. The information collected will be used to support the dossier submission of Novartis drug Erenumab® (AMG334) to become licensed as a second line migraine treatment for patients who have failed 1 or more standard migraine drug. As this is a non-interventional study, patients will be identified during routine clinical practice and asked attend a single visit to complete a patient interview and set of questionnaires.
Approximately 2462 patients across Europe will participate in the study. Approximately 140 of these patients will be recruited from sites in the UK and 54 from sites in Ireland. Data collection is expected to begin on 15th December 2017 and end on 15th March 2018.
REC name
North East - York Research Ethics Committee
REC reference
17/NE/0370
Date of REC Opinion
21 Nov 2017
REC opinion
Favourable Opinion