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

Primary Purpose

Primary Erythromelalgia, Inherited Erythromelalgia

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
XPF-001
Placebo
Sponsored by
Xenon Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Erythromelalgia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Centre at Radboud University Nijmegen Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Matching Placebo

XPF-001

Arm Description

Outcomes

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)

Secondary Outcome Measures

Full Information

First Posted
March 17, 2010
Last Updated
March 14, 2012
Sponsor
Xenon Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01090622
Brief Title
Study of XPF-001 in the Treatment of Pain From Primary/Inherited Erythromelalgia (IEM)
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 Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xenon Pharmaceuticals Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Erythromelalgia, Inherited Erythromelalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Arm Title
XPF-001
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
XPF-001
Intervention Description
Oral capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral capsule
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joost PH Drenth, MD PhD
Organizational Affiliation
Radboud University Nijmegen Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Centre at Radboud University Nijmegen Medical Center
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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