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

• Status: Terminated
• Trial end date: 2019-02-07
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen; Convergence Pharmaceuticals

Criteria

Key Inclusion Criteria:

• Has completed Study 1014802-203 for its complete duration.

Key Exclusion Criteria:

• Has met an exclusion criterion for the preceding double-blind Phase 2b study (Study 1014802-203).

• Had a protocol deviation regarding inclusion or exclusion criteria for the double-blind Phase 2b study (Study 1014802-203).

• Had a treatment-related AE or SAE that would pose an increased risk for continued treatment with BIIB074, or discontinued study treatment in the double-blind Phase 2b study (Study 1014802-203) due to an AE or SAE.

• Did not return for all study visits after discontinuing treatment in the double-blind phase of the Phase 2b study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply