drugset / Trial / NCT02957617
Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2017-02-10
- Primary completion
- 2019-02-07
- Completion
- 2019-02-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vixotrigine | Small molecule | 200 mg | Oral |
| Subject | Vixotrigine | Small molecule | 350 mg | Oral |