Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01486446 | Phase 2a, Exploratory Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of XPF-002 in Patients With Primary/Inherited Erythromelalgia | PHASE1 | COMPLETED | 8 | — | — | Dec 1, 2011 | May 1, 2012 | Apr 14, 2014 | 1 | United States |
Using diary cards, subjects recorded the use of all non-pharmacological cooling methods used to relieve their erythromelalgia (EM) pain each day during Treatment Period 2. A smaller average number of cooling uses each day in Treatment Period 2 indicates that subjects were in less pain/required less use of cooling to relieve their EM pain and vice versa.
| Arm | Type | Description |
|---|---|---|
| XPF-002 | EXPERIMENTAL | XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days |
| Placebo | PLACEBO_COMPARATOR | XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days. |
| Name | Type | Description |
|---|---|---|
| XPF-002 | DRUG | XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days |
| Placebo | DRUG | XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days. |
Inclusion Criteria: * Must have a Body Mass Index (BMI) of 18-40 kg/m2 (inclusive) * Have primary or inherited erythromelalgia (IEM) * Experience flares of pain in your feet or hands caused by erythromelalgia * Be generally healthy (apart from your pain) * Stop taking your usual pain medications an...