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

Inherited Erythromelalgia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01090622
• Other study ID #: XPF-001-202
• Secondary ID: 2009-015619-42
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 17, 2010
• Last updated: March 14, 2012
• Start date: April 2010
• Est. completion date: September 2010

Study information

• Verified date: March 2012
• Source: Xenon Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erythromelalgia
• Inherited Erythromelalgia
• Primary Erythromelalgia

Intervention

Drug:
• XPF-001
Oral capsule
• Placebo
Oral capsule

Locations

Country	Name	City	State
Netherlands	Clinical Research Centre at Radboud University Nijmegen Medical Center	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Xenon Pharmaceuticals Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		2 days	No

External Links

•   Study Website