Study of XPF-001 in the Treatment of Pain From Primary/Inherited Erythromelalgia (IEM)
NCT ID: NCT01090622
Last Updated: 2012-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
4 participants
INTERVENTIONAL
2010-04-30
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Matching Placebo
Placebo
Oral capsule
XPF-001
XPF-001
Oral capsule
Interventions
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XPF-001
Oral capsule
Placebo
Oral capsule
Eligibility Criteria
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Inclusion Criteria
* 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
* 9-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.
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Xenon Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joost PH Drenth, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Nijmegen Medical Center
Locations
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Clinical Research Centre at Radboud University Nijmegen Medical Center
Nijmegen, , Netherlands
Countries
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Other Identifiers
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2009-015619-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
XPF-001-202
Identifier Type: -
Identifier Source: org_study_id
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