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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xenon Pharmaceuticals Inc.

Criteria

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