Trials / Completed
CompletedNCT02935608
Study to Evaluate the Efficacy and Safety of BIIB074 in Neuropathic Pain From Lumbosacral Radiculopathy
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 502 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to evaluate the efficacy of two dose regimens of BIIB074 on neuropathic pain in participants with pain from lumbosacral radiculopathy (PLSR). Secondary objectives are to evaluate the efficacy of 2 dose regimens of BIIB074 on additional neuropathic pain measures and assessments of low back pain, disability, and quality of life; To investigate the safety and tolerability of 2 dose regimens of BIIB074 and To characterize the pharmacokinetics (PK) of BIIB074 in this population.
Detailed description
This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BIIB074 | Administered as specified in the treatment arm |
| DRUG | Placebo | Matched placebo |
Timeline
- Start date
- 2016-10-31
- Primary completion
- 2018-08-06
- Completion
- 2018-08-06
- First posted
- 2016-10-17
- Last updated
- 2018-08-15
Locations
56 sites across 14 countries: Austria, Belgium, Bulgaria, Czechia, France, Georgia, Italy, Latvia, Netherlands, Romania, Serbia, Slovakia, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02935608. Inclusion in this directory is not an endorsement.