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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Pati

Brief 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 Summary:

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.


Sponsor: Xenon Pharmaceuticals Inc.

Current Primary Outcome: Average Daily Use of Cooling for Erythromelalgia-Related Pain in Treatment Period 2 [ Time Frame: 14-21 Days ]

Using diary cards, subjects recorded the use of all non-pharmacological cooling methods used to relieve their erythromelalgia (EM) pain each day during Treatment Period 2.

A smaller average number of cooling uses each day in Treatment Period 2 indicates that subjects were in less pain/required less use of cooling to relieve their EM pain and vice versa.



Original Primary Outcome: Difference in pain intensity from pre-treatment to end of treatment based on an 11-point NRS scale (0-10, where 0=no pain and 10=worst pain you can imagine) [ Time Frame: 5 days ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Xenon Pharmaceuticals Inc.

Dates:
Date Received: December 2, 2011
Date Started: December 2011
Date Completion:
Last Updated: March 10, 2014
Last Verified: March 2014