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