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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014