Study of XPF-001 in the Treatment of Pain From Primary/Inherited Erythromelalgia (IEM)

X

Xenon Pharmaceuticals

Status and phase

Completed
Phase 2
Phase 1

Conditions

Inherited Erythromelalgia
Primary Erythromelalgia

Treatments

Drug: Placebo
Drug: XPF-001

Study type

Interventional

Funder types

Industry

Identifiers

NCT01090622
2009-015619-42 (EudraCT Number)
XPF-001-202

Details and patient eligibility

About

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).

Enrollment

4 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
  • 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

  • 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

Trial design

4 participants in 2 patient groups, including a placebo group

Matching Placebo
Placebo Comparator group
Treatment:
Drug: Placebo
XPF-001
Experimental group
Treatment:
Drug: XPF-001

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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