Phase 2b with BII074 in subjects with neuropathic back pain
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
IRAS ID
199365
Contact name
Michael Serpell
Contact email
Sponsor organisation
Biogen Idec Research Limited
Eudract number
2015-004775-78
Clinicaltrials.gov Identifier
NIHR CRN , ANAE 5449
Duration of Study in the UK
1 years, 3 months, 0 days
Research summary
Lumbosacral radiculopathy (LSR) is characterised by nerve pain (P) due to degenerative changes in the lower part of the spinal column. Anti-inflammatory drugs and steroid injections in the spinal column are mainly used for the treatment of PLSR. Surgery can also be an option. However, there is no medication that has been approved to relieve the back pain in patients with PLSR.
Non-clinical and previous clinical studies suggested that treatment with BIIB074 (investigational product) is effective for neuropathic pain and shows a better tolerability than currently available treatments.
The purpose of the study is to determine the beneficial effect and safety of two doses of BII074 in participants with PLSR.
The study consists of two treatment phases:
- the run-in phase where all the eligible patients will receive single-blind placebo for 2 weeks, in order to select only patients who do not respond to placebo
- and then the randomised phase where patients with at least moderate pain intensity will be assigned BII074 or placebo for 12 additional weeks.The study will be up to 20 weeks including 28 days of screening, the above described treatment phases and 1 week follow-up. At the end of the treatment period eligible patients may continue into the extension study.
In total, there will be about 630 subjects participating in this study around the world to insure that 399 participants will be randomised. Around 24 subjects from the UK will participate to the study.
REC name
West of Scotland REC 1
REC reference
16/WS/0109
Date of REC Opinion
20 Jul 2016
REC opinion
Further Information Favourable Opinion