A Phase 2a Study of BIIB074 in the Treatment of Erythromelalgia

• Status: Completed
• Trial end date: 2017-01-05
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to investigate the efficacy of repeat oral dosing of BIIB074 on paroxysmal pain in participants with Primary Inherited Erythromelalgia (EM). The secondary objective of the study is to investigate the efficacy of repeat oral dosing of BIIB074 on varying additional aspects of pain in participants with EM; and to investigate the safety and tolerability of repeat oral dosing of BIIB074 in participants with EM.

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

Details

• Lead Sponsor: Biogen; Convergence Pharmaceuticals

Criteria

Key Inclusion Criteria:

• A diagnosis of primary inherited EM with family history of EM made at least 3 months from initial diagnosis.

• Failed at least one prior treatment for EM (defined as an inadequate response or intolerance to treatment).

• Approved concomitant medications must have been stable for at least 4 weeks prior to day 1.

Key Exclusion Criteria:

• Positive screening Hepatitis B surface antigen or positive Hepatitis C antibody result.

• Received nerve blocks and/or steroid injections for neuropathic pain within 4 weeks prior to Day 1.

• Males whose partner is pregnant.

• Failed at least one prior treatment for EM (defined as an inadequate response or intolerance to treatment).

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.