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OpenTrials
Completed

NCT Number: NCT01090622

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

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).

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Key information

Conditions

Primary Erythromelalgia Cardiovascular Diseases Erythromelalgia Inherited Erythromelalgia Peripheral Vascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinical Research Centre at Radboud University Nijmegen Medical Center

Nijmegen, 6500 HB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XPF-001

Drug

Oral capsule

Placebo

Drug

Oral capsule

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Xenon Pharmaceuticals Inc.

Industry

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 22, 2010
Registry last updated
Mar 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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