Phase 2a, Exploratory Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of XPF-002 in Patients With Primary/Inherited Erythromelalgia

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Primary Erythromelalgia, Inherited Erythromelalgia

In brief

This is a Phase 2a single-center, randomized, double-blind, Placebo-controlled, parallel group study with XPF-002 applied twice daily over 14 or 21 days in patients with Primary/Inherited Erythromelalgia (IEM). The purpose of this study is to determine whether XPF-002 is safe and effective in the treatment of pain caused by IEM.

Key facts

Study ID: NCT01486446
Run by: Xenon Pharmaceuticals Inc.
People needed: 8
Starts: 2011-12-01
Expected to finish: 2012-05-01
Last updated by the study team: 2014-04-14

Who can join

Age: 19 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Must have a Body Mass Index (BMI) of 18-40 kg/m2 (inclusive)
Have primary or inherited erythromelalgia (IEM)
Experience flares of pain in your feet or hands caused by erythromelalgia
Be generally healthy (apart from your pain)
Stop taking your usual pain medications and certain other medications for up to 11.5 weeks
Not be pregnant or breast-feeding
Must be able and willing to provide informed consent and willing to comply with all study procedures and restrictions

You may not qualify if…

Must not be in constant pain (must not continually be in moderate pain, 3/10 or more)
Coexistent source of pain from other conditions that may interfere with the study interpretation
HIV, Hepatitis B or C
Treatment for significant depression within 6 months of Screening
Not willing to use adequate contraception
Alcoholism, alcohol or substance abuse
Presence or history of major psychiatric disturbance
Any other condition or finding that may pose undue risk for participation
Use of any other investigational drug in the 30 days prior to dosing
Donation or loss of whole blood or plasma prior to dosing as follows: 50 mL to 499 mL within 30 days, or more than 499 mL within 56 days
Employee or relative of an employee who is directly involved in the study

Where it is running

Pinnacle Research Group, LLC. — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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