Study of XPF-001 in the Treatment of Pain From Primary/Inherited Erythromelalgia (IEM)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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 Start Date
Primary Completion Date
Study Completion Date
Resource links provided by the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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