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

Xenon Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Inherited Erythromelalgia; Primary Erythromelalgia

Treatments: Drug: Placebo; Drug: XPF-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT01090622

2009-015619-42 (EudraCT Number)

XPF-001-202

Details and patient eligibility

About

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).

Enrollment: 4 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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4 participants in 2 patient groups, including a placebo group

Matching Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

XPF-001

Experimental group

Treatment:

Drug: XPF-001