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 range
19 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Average Daily Use of Cooling for Erythromelalgia-Related Pain in Treatment Period 2