Phase 2a, Single-Blind, Placebo-Controlled, 3-Period, 2-Treatment, Crossover Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Oral Doses of XPF-001 in Patients with Inherited Erythromelalgia

• Conditions: Inherited erythromelalgia; MedDRA version: 12.0Level: LLTClassification code 10015284Term: Erythromelalgia

• Registration Number: EUCTR2009-015619-42-NL
• Lead Sponsor: Xenon Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Subjects will include males and females 18 – 75 years of age (inclusive), with a BMI between 19.5 and 34.0 kg/m2 (inclusive) who have a clinical and genetic diagnosis of Inherited Erythromelalgia (IEM);
Subjects must (either spontaneously, or using one of the protocol-defined pain induction methods) achieve pain scores of
NRS ³4, and/or moderate/severe on the CRS, or an intolerable level of pain irrespective of pain scores;
Subjects must be willing to comply with all study procedures, including the stopping use of all medication, including those for pain management between Check-in and Discharge;
Subjects must be in general good health and have no contraindications to the IMP, its excipients, or the permitted rescue medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects with a coexistent source of pain from other conditions that may interfere with the study interpretation;
History or evidence of any condition that, in the opinion of the PI, may pose undue risk to the subject;
A positive test for HIV, Hepatitis C antibodies, or Hepatitis B surface antigen;
Use of any prescription or over the counter (OTC) medication or supplement from Check-in until Discharge (except for rescue medication);
Receiving professional psychological support specifically for coping with IEM;
Treatment for significant depression within the 6 months prior to Screening;
Females who are pregnant, lactating, or who test positive on a serum-based regnancy test at Screening or Check-in;
Not currently undertaking adequate measures to prevent a pregnancy throughout the entire study;
Clinically significant abnormal laboratory values, ECG, vital signs or physical examination findings at Screening or Check-in;
History or presence of alcoholism or alcohol or substance abuse (not including nicotine or caffeine);
Presence or history of major psychiatric disturbance and/or substance abuse, or a positive urine drug test at Check-in;
Ingestion of any caffeine-containing food or beverages (including chocolate) in excess of the permitted 1 cup of caffeine containing beverage per day, between Day -1 until Discharge;
Consumption of alcohol from Check-in until Discharge, or a positive alcohol breath test on Check-in;
Consumption of grapefruit or grapefruit containing products within 7 days of Day 1 until Discharge;
Smoking more than 3 cigarettes per day (or the equivalent in tobacco or nicotine substitutes) within the 1 week prior to ICheck-in, and the inability to refrain from all nicotine use between Check-in and Discharge;
Has taken an investigational drug within the 60 days prior to Day 1;
Donation or loss of whole blood or plasma (excluding the volume of blood that will be drawn during the Screening procedures of this study) prior to Day 1 as follows: 50 mL to 499 mL within 30 days, or more than 499 mL within 56 days prior to drug administration;
Has previously been enrolled into this study;
Study site or Sponsor employee or relative of an employee who is directly involved in the study;
Any other reason that would make the subject, in the opinion of the PI or Sponsor, unsuitable for the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified