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

Outcome

Outcome not reported

Stopped (Business): “The parent study did not meet its primary or secondary efficacy endpoints and therefore Sponsor decision to discontinue development in this indication.”

Drugs

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

Indications