Study of XPF-001 in the Treatment of Pain From Primary/Inherited Erythromelalgia (IEM)

Phase 2a, Double-blind, Placebo-controlled, 2-period, Crossover Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Oral Doses of XPF-001 in Patients With Inherited Erythromelalgia.

The purpose of this study is to determine whether XPF-001 is safe and effective in the treatment of pain caused by Inherited Erythromelalgia (IEM).

Inclusion Criteria:

The study requires you to:

• Be18-75 years old
• Have inherited erythromelalgia
• Be experiencing pain caused by erythromelalgia (Moderate pain score 4/10)
• Be generally healthy (apart from your pain)
• Stop taking your usual pain medications for 9 days
• Not be pregnant or breast-feeding

Your role in the study includes:

• An out-patient screening visit
• 9-days/8 nights-in-patient treatment visit at Nijmegen Medical Center (where you will be closely monitored)
• A follow up phone call (after your return home)
• Taking the investigational medication daily
• Recording your pain levels daily during stay at the Medical Center.

Exclusion Criteria:

• Coexistent source of pain from other conditions
• Receiving professional psychological support for dealing with IEM
• Treatment for significant depression within 6 months of screening
• Active HIV, Hepatitis B or C
• Use of prescription or OTC medication between check-in and discharge
• Women who are pregnant, or lactating
• Not currently using adequate contraception
• Alcoholism or alcohol or substance abuse
• Presence or history of major psychiatric disturbance
• Unwilling or unable to comply with all dietary and activity restrictions
• Any other condition or finding that may pose undue risk for participation
• Use of any other investigational drug in the 60 days prior to dosing