Status:
COMPLETED
Phase 2a, Exploratory Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of XPF-002 in Patients With Primary/Inherited Erythromelalgia
Lead Sponsor:
Xenon Pharmaceuticals Inc.
Conditions:
Primary Erythromelalgia
Inherited Erythromelalgia
Eligibility:
All Genders
19-80 years
Phase:
PHASE1
PHASE2
Brief 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 Erythromelal...
Detailed Description
Your role in the study would include: * Travelling to the clinic (in Anniston, Alabama, USA) for 3 out-patient visits, each lasting approximately 1 day * Travelling and staying in the clinic for 2 in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01486446
Start Date
December 1 2011
End Date
May 1 2012
Last Update
April 14 2014
Active Locations (1)
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1
Pinnacle Research Group, LLC.
Anniston, Alabama, United States, 36201