Phase 2 Extension with BIIB074 in Subjects with Neuropathic Back Pain
Research type
Research Study
Full title
An Uncontrolled, Open-Label Extension Study to Evaluate the Long Term Safety, Tolerability, and Maintenance of Effect of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
IRAS ID
214145
Contact name
Michael Serpell
Contact email
Sponsor organisation
Biogen Idec Research Limited
Eudract number
2015-004796-68
Clinicaltrials.gov Identifier
NIHR CRN, ANAE 5466
Duration of Study in the UK
2 years, 1 months, 16 days
Research summary
Pain from Lumbosacral Radiculopathy (PLSR) is a condition that arises from the compression of nerve roots in the lower area of the spinal column causing pain in the lower limbs and/or lower back. A variety of pain medications including opiates, are used with limited efficacy and poor tolerability. While surgery may be an option or some subjects, there are currently no approved medications available to treat this type of neuropathic pain. Therefore, PLSR represents an area of high unmet medical need.\n\nNon-clinical and previous clinical studies suggest that 8118074 (investigational product) is effective at treating neuropathic pain and potentially is better tolerated than the currently available treatments.\n\nSubjects who complete the main phase 2b study 1014802-203 will be eligible to participate in this extension study including subjects who discontinue the study treatment but who continue to document their pain scores and return for all study visits. Subjects who discontinue the main study due to a treatment related adverse event or serious adverse event will not be eligible.\n\nThere is one treatment group for this study: All subjects will receive an initial dose of 350mg of BIIB074 twice daily {BID). This may be reduced to 200mg BID based on tolerability. As this is an open label study, the subjects will know what treatment they are receiving.\n\nThe number of subjects participating in the study will be determined by how many subjects complete study 1014802-203. Assuming an 80% completion rate in study 1014802-203, approximately 302 subjects will be enrolled into this open label extension\nstudy.\n\nThe study duration for each subject will be approximately 13 months; a 12 month treatment period, a 7-10 day follow up period and a telephone call 4 weeks after the last dose.\n\nThe purpose of this open-label extension study is to assess the long-term safety, tolerability and the maintenance of effect of BIIB074 in subjects with neuropathic pain from Lumbosacral radiculopathy (PLSR) who have completed the main phase 2b study\n1014802-203.
REC name
West of Scotland REC 1
REC reference
16/WS/0199
Date of REC Opinion
19 Oct 2016
REC opinion
Favourable Opinion