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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01090622
Recruitment Status : Completed
First Posted : March 22, 2010
Last Update Posted : March 16, 2012
Information provided by (Responsible Party):
Xenon Pharmaceuticals Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Primary Erythromelalgia Inherited Erythromelalgia Drug: XPF-001 Drug: Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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 Start Date : April 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Matching Placebo Drug: Placebo
Oral capsule
Experimental: XPF-001 Drug: XPF-001
Oral capsule

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01090622

Clinical Research Centre at Radboud University Nijmegen Medical Center
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Xenon Pharmaceuticals Inc.
Principal Investigator: Joost PH Drenth, MD PhD Radboud University Nijmegen Medical Center

Additional Information:
Responsible Party: Xenon Pharmaceuticals Inc. Identifier: NCT01090622     History of Changes
Other Study ID Numbers: XPF-001-202
2009-015619-42 ( EudraCT Number )
First Posted: March 22, 2010    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases