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

Overview

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).

Full Title of Study: “Phase 2a, Double-blind, Placebo-controlled, 2-period, Crossover Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Oral Doses of XPF-001 in Patients With Inherited Erythromelalgia.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 2010

Interventions

  • Drug: XPF-001
    • Oral capsule
  • Drug: Placebo
    • Oral capsule

Arms, Groups and Cohorts

  • Placebo Comparator: Matching Placebo
  • Experimental: XPF-001

Clinical Trial Outcome Measures

Primary Measures

  • Pain intensity difference (PID) in each treatment period based on an 11-point Pain Intensity-NRS (where 0 = No pain and 10 = worst pain you can imagine)
    • Time Frame: 2 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Xenon Pharmaceuticals Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joost PH Drenth, MD PhD, Principal Investigator, Radboud University Nijmegen Medical Center

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.