Study of XPF-001 in the Treatment of Pain From Primary/Inherited Erythromelalgia (IEM)
Phase 1
Completed
- Conditions
- Primary ErythromelalgiaInherited Erythromelalgia
- Interventions
- Drug: PlaceboDrug: XPF-001
- Registration Number
- NCT01090622
- Lead Sponsor
- Xenon Pharmaceuticals Inc.
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Matching Placebo Placebo - XPF-001 XPF-001 -
- Primary Outcome Measures
Name Time Method 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) 2 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Research Centre at Radboud University Nijmegen Medical Center
🇳🇱Nijmegen, Netherlands