CompletedPhase 2

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

United States8 participantsStarted 2016-09-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Weekly average severity of paroxysms

Timeframe: Day 1 to Week 12

Trial details

NCT IDNCT02917187

SponsorBiogen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12-27

View on ClinicalTrials.gov More Primary Inherited Erythromelalgia trials