Study of XPF-001 in the Treatment of Pain From Primary/Inherited Erythromelalgia (IEM)
Phase 2a, Double-blind, Placebo-controlled, 2-period, Crossover Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Oral Doses of XPF-001 in Patients With Inherited Erythromelalgia.
2 other identifiers
interventional
4
1 country
1
Brief Summary
The purpose of this study is to determine whether XPF-001 is safe and effective in the treatment of pain caused by Inherited Erythromelalgia (IEM).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2010
CompletedFirst Posted
Study publicly available on registry
March 22, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedMarch 16, 2012
March 1, 2012
4 months
March 17, 2010
March 14, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Pain intensity difference (PID) in each treatment period based on an 11-point Pain Intensity-NRS (where 0 = No pain and 10 = worst pain you can imagine)
2 days
Study Arms (2)
Matching Placebo
PLACEBO COMPARATORXPF-001
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- The study requires you to:
- Be18-75 years old
- Have inherited erythromelalgia
- Be experiencing pain caused by erythromelalgia (Moderate pain score 4/10)
- Be generally healthy (apart from your pain)
- Stop taking your usual pain medications for 9 days
- Not be pregnant or breast-feeding
- Your role in the study includes:
- An out-patient screening visit
- days/8 nights-in-patient treatment visit at Nijmegen Medical Center (where you will be closely monitored)
- A follow up phone call (after your return home)
- Taking the investigational medication daily
- Recording your pain levels daily during stay at the Medical Center.
You may not qualify if:
- Coexistent source of pain from other conditions
- Receiving professional psychological support for dealing with IEM
- Treatment for significant depression within 6 months of screening
- Active HIV, Hepatitis B or C
- Use of prescription or OTC medication between check-in and discharge
- Women who are pregnant, or lactating
- Not currently using adequate contraception
- Alcoholism or alcohol or substance abuse
- Presence or history of major psychiatric disturbance
- Unwilling or unable to comply with all dietary and activity restrictions
- Any other condition or finding that may pose undue risk for participation
- Use of any other investigational drug in the 60 days prior to dosing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Research Centre at Radboud University Nijmegen Medical Center
Nijmegen, 6500 HB, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joost PH Drenth, MD PhD
Radboud University Nijmegen Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2010
First Posted
March 22, 2010
Study Start
April 1, 2010
Primary Completion
August 1, 2010
Study Completion
September 1, 2010
Last Updated
March 16, 2012
Record last verified: 2012-03