Phase 2
N=8
Phase 2a, Exploratory Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of XPF-002 in Patients With Primary/Inherited Erythromelalgia
Primary Erythromelalgia · Inherited Erythromelalgia
Bottom Line
View on ClinicalTrials.gov: NCT01486446 ↗Enrolled (actual)
8
Serious AEs
12.5%
Results posted
Apr 2014
Primary outcome: Primary: Average Daily Use of Cooling for Erythromelalgia-Related Pain in Treatment Period 2 — 0.24; 2.4 cooling uses/day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- XPF-002 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Xenon Pharmaceuticals Inc.
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Daily Use of Cooling for Erythromelalgia-Related Pain in Treatment Period 2 |
0.24; 2.4 | — |
Summary
This is a Phase 2a single-center, randomized, double-blind, Placebo-controlled, parallel group study with XPF-002 applied twice daily over 14 or 21 days in patients with Primary/Inherited Erythromelalgia (IEM). The purpose of this study is to determine whether XPF-002 is safe and effective in the treatment of pain caused by IEM.
Eligibility Criteria
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 and certain other medications for up to 11.5 weeks
- Not be pregnant or breast-feeding
- Must be able and willing to provide informed consent and willing to comply with all study procedures and restrictions
Exclusion Criteria
- Must not be in constant pain (must not continually be in moderate pain, 3/10 or more)
- Coexistent source of pain from other conditions that may interfere with the study interpretation
- HIV, Hepatitis B or C
- Treatment for significant depression within 6 months of Screening
- Not willing to use adequate contraception
- Alcoholism, alcohol or substance abuse
- Presence or history of major psychiatric disturbance
- Any other condition or finding that may pose undue risk for participation
- Use of any other investigational drug in the 30 days prior to dosing
- Donation or loss of whole blood or plasma prior to dosing as follows: 50 mL to 499 mL within 30 days, or more than 499 mL within 56 days
- Employee or relative of an employee who is directly involved in the study
Data sourced from ClinicalTrials.gov (NCT01486446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.