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

Biogen

Status and phase: Completed; Phase 2

Conditions: Primary Inherited Erythromelalgia

Treatments: Drug: Placebo; Drug: BIIB074

Study type: Interventional

Funder types: Industry

Identifiers

NCT02917187

1014802-205

Details and patient eligibility

About

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.

Full description

This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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8 participants in 2 patient groups

Randomized Group 1

Experimental group

Description:

After two week run-in, BIIB074 three times a day (TID) followed by placebo (TID) after two week washout period

Treatment:

Drug: BIIB074

Drug: Placebo

Randomized Group 2

Experimental group

Description:

After two week run-in, Placebo three times a day (TID) followed by BIIB074 (TID) after two week washout period

Treatment:

Drug: BIIB074

Drug: Placebo