NCT01486446

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

Phase 2a, Exploratory, Double-blind, Placebo-controlled Two-part Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of Topically Applied XPF-002 (XEN402 8% w/w Ointment) in Patients With Primary/Inherited Erythromelalgia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Xenon Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Your role in the study would include: * Travelling to the clinic (in Anniston, Alabama, USA) for 3 out-patient visits, each lasting approximately 1 day * Travelling and staying in the clinic for 2 in-patient stays: * For the first in-patient visit you will have to spend 8 days and 7 nights in the clinic * For the second in-patient visit you will have to spend 2 days and 1 night in the clinic You can bring books, laptops and DVDs to the clinic. If you do not live within driving distance to the clinic you will need to stay in the local area (in Anniston, at a local hotel) for 1 to 2 weeks while you use the ointment, in addition to the in-patient portion of the study.

Conditions

• Primary Erythromelalgia
• Inherited Erythromelalgia

Interventions

Type	Name	Description
DRUG	XPF-002	XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
DRUG	Placebo	XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-04-01
• Completion: 2012-05-01
• First posted: 2011-12-06
• Last updated: 2014-04-14
• Results posted: 2014-04-14

Locations

1 site across 1 country: United States