Study of XPF-001 in the Treatment of Pain From Primary/Inherited Erythromelalgia (IEM) (NCT01090622) | Clinical Trial Compass
CompletedPhase 1/2
Study of XPF-001 in the Treatment of Pain From Primary/Inherited Erythromelalgia (IEM)
Netherlands4 participantsStarted 2010-04
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
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)