Study of XPF-001 in the Treatment of Pain From Primary/In... | NCT01090622

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

NCT01090622

Sponsor

Xenon Pharmaceuticals Inc.

Status

Completed

Last Update Posted

Mar 16, 2012Estimated

Enrollment

4Actual

Phase

Phase 1Phase 2

Conditions

Primary Erythromelalgia
Inherited Erythromelalgia

Interventions

XPF-001
Placebo

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-015619-42	EudraCT Number

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Aug 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Mar 17, 2010

First Submission Date that Met QC Criteria

Mar 18, 2010

First Posted Date

Mar 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2012

Last Update Posted Date

Mar 16, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Label	Type	Description	Intervention Names
Matching Placebo	Placebo Comparator		Drug: Placebo
XPF-001	Experimental		Drug: XPF-001

Name	Type	Description	Arm Group Labels	Other Names
XPF-001	Drug	Oral capsule	XPF-001
Placebo

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D016491	Peripheral Vascular Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases