Phase 2a, Exploratory Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics o… (NCT01486446) | Clinical Trial Compass
CompletedPhase 1/2
Phase 2a, Exploratory Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of XPF-002 in Patients With Primary/Inherited Erythromelalgia
United States8 participantsStarted 2011-12
Plain-language 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.
Who can participate
Age range19 Years – 80 Years
SexALL
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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
What they're measuring
1
Average Daily Use of Cooling for Erythromelalgia-Related Pain in Treatment Period 2