drugset / Trial / NCT02957617

Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074

NCT02957617

Phase 2 Terminated 302 enrolled Biogen
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

EvaluationDrugModalityDoseRoute
Subject Vixotrigine Small molecule 200 mg Oral
Subject Vixotrigine Small molecule 350 mg Oral

Indications