Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074 (RELAY-1 Extend)

Biogen

Status and phase

Terminated

Phase 2

Conditions

Neuropathic Pain From Lumbosacral Radiculopathy

Treatments

Drug: BIIB074

Study type

Interventional

Funder types

Industry

Identifiers

NCT02957617

2015-004796-68 (EudraCT Number)

1014802-204

Details and patient eligibility

About

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).

Full description

This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen. This is an extension study to 1014802-203.

Enrollment

302 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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