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 range

18 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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