Trial record 2 of 3 for:    ERYTHERMALGIA, PRIMARY

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xenon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01090622
First received: March 17, 2010
Last updated: March 14, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Primary Erythromelalgia
Inherited Erythromelalgia
Drug: XPF-001
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Xenon Pharmaceuticals Inc.:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: April 2010
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Matching Placebo Drug: Placebo
Oral capsule
Experimental: XPF-001 Drug: XPF-001
Oral capsule

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01090622

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

Additional Information:
No publications provided

Responsible Party: Xenon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01090622     History of Changes
Other Study ID Numbers: XPF-001-202, 2009-015619-42
Study First Received: March 17, 2010
Last Updated: March 14, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on April 17, 2014