802NP301 Biogen - BIIB074 - SURGE-1- Trigeminal Neuralagia
Research type
Research Study
Full title
A Phase 3 Placebo-Controlled, Double-Blind Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Trigeminal Neuralgia
IRAS ID
218316
Contact name
Prof. Joanna. M. Zakrzewska
Contact email
Sponsor organisation
Biogen
Eudract number
2016-001449-16
Duration of Study in the UK
2 years, 9 months, 4 days
Research summary
This is A phase 3 clinical trial of 220–250 Adult (≥ 18 years) with Trigeminal Neuralgia run in approximately 90 global sites. The study drug is state dependent voltage-gated sodium channel inhibitor called BIIB074. This is an investigational drug. It has been tested in patients before but in this study more patients will receive the drug to check how well it works and how safe it is. The trial will look at how many people have a reduction in their pain after 12 weeks.
BIIB074 is a tablet that will be taken three times a day. The first dose is given in hospital, the other doses are taken at home. The first part of this study is open-label meaning the doctor and participant will know what drug is being received but in this study the dose being received will not be known. The participants will receive either 150mg or 250mg of BIIB074. After 4 – 6 weeks of open-label treatment participants for whom BIIB074 is working will be randomised into the second part of the study 1:1 to either placebo (a dummy drug) or more BIIB074. Randomisation is like flipping a coin, participant and doctor do not choose the treatment. This part is double-blind meaning neither the participant nor the doctor know which treatment the participant is taking.
Study duration for each participant will vary. Initially duration will be up to approximately 19-21 weeks - screening (up to 2 weeks), run-in (1 week), open-label (4 or 6 weeks) and double-blind period (12 weeks). If participants complete the double-blind period of the study and meet the criteria they will be offered an option to enter the Long-Term Extension part of the study for upto 52 weeks further treatment. A follow-Up Visit will be conducted 7-10 days after the last visit.
REC name
London - Fulham Research Ethics Committee
REC reference
17/LO/0308
Date of REC Opinion
2 Mar 2017
REC opinion
Favourable Opinion