Phase 2a, Exploratory Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of XPF-002 in Patients With Primary/Inherited Erythromelalgia

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2a single-center, randomized, double-blind, Placebo-controlled, parallel group study with XPF-002 applied twice daily over 14 or 21 days in patients with Primary/Inherited Erythromelalgia (IEM). The purpose of this study is to determine whether XPF-002 is safe and effective in the treatment of pain caused by IEM.

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

Details

• Lead Sponsor: Xenon Pharmaceuticals Inc.

Criteria

Inclusion Criteria:

• Must have a Body Mass Index (BMI) of 18-40 kg/m2 (inclusive)

• Have primary or inherited erythromelalgia (IEM)

• Experience flares of pain in your feet or hands caused by erythromelalgia

• Be generally healthy (apart from your pain)

• Stop taking your usual pain medications and certain other medications for up to 11.5 weeks

• Not be pregnant or breast-feeding

• Must be able and willing to provide informed consent and willing to comply with all study procedures and restrictions

Exclusion Criteria:

• Must not be in constant pain (must not continually be in moderate pain, 3/10 or more)

• Coexistent source of pain from other conditions that may interfere with the study interpretation

• HIV, Hepatitis B or C

• Treatment for significant depression within 6 months of Screening

• Not willing to use adequate contraception

• Alcoholism, alcohol or substance abuse

• Presence or history of major psychiatric disturbance

• Any other condition or finding that may pose undue risk for participation

• Use of any other investigational drug in the 30 days prior to dosing

• Donation or loss of whole blood or plasma prior to dosing as follows: 50 mL to 499 mL within 30 days, or more than 499 mL within 56 days

• Employee or relative of an employee who is directly involved in the study