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XPF-001

Phase 1

Primary Erythromelalgia | Small molecule | Rare Disease |Xenon Pharmaceuticals Inc.|Last Updated: Mar 16, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment4
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01090622Study of XPF-001 in the Treatment of Pain From Primary/Inherited Erythromelalgia (IEM)PHASE1 COMPLETED 4Apr 1, 2010Sep 1, 2010Mar 16, 20121 Netherlands
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Study Endpoints
Primary Endpoints
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Matching PlaceboPLACEBO_COMPARATOR -
XPF-001EXPERIMENTAL -
Interventions
NameTypeDescription
XPF-001DRUGOral capsule
PlaceboDRUGOral capsule
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 br...

Countries:Netherlands
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