Trials / Terminated
TerminatedNCT02957617
Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074
An Uncontrolled, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074 (Vixotrigine) in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 302 (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 long-term safety and tolerability of BIIB074 in participants with neuropathic Pain From Lumbosacral Radiculopathy (PLSR). A secondary objective is to investigate the maintenance of effect during long-term treatment with BIIB074 in participants with neuropathic PLSR. For all efficacy assessments, baseline will be prior to randomization into Study 1014802-203. Another secondary objective is to evaluate the impact of treatment with BIIB074 on quality of life (QoL).
Detailed description
This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen. This is an extension study to 1014802-203.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BIIB074 | Participants will receive an initial dose regimen of 350mg orally twice daily (BID), which may be reduced to 200mg based on tolerability for up to 12 months. |
Timeline
- Start date
- 2017-02-10
- Primary completion
- 2019-02-07
- Completion
- 2019-02-07
- First posted
- 2016-11-08
- Last updated
- 2019-02-25
Locations
51 sites across 14 countries: Austria, Belgium, Bulgaria, Czechia, Estonia, France, Georgia, Italy, Latvia, Romania, Serbia, Slovakia, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02957617. Inclusion in this directory is not an endorsement.