Primary ErythromelalgiaPhase 1/2NCT01090622
Study of XPF-001 in the Treatment of Pain From Primary/Inherited Erythromelalgia (IEM)
A Phase 1/2 study testing XPF-001 in people with Primary Erythromelalgia and Inherited Erythromelalgia, run by Xenon Pharmaceuticals Inc. at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Erythromelalgia, Inherited Erythromelalgia
- What is being tested?
- XPF-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2010to Sep 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
Netherlands1 site
Clinical Research Centre at Radboud University Nijmegen Medical Center
Nijmegen, 6500 HB
About this study
Official title: 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.
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).
- Conditions
- Primary Erythromelalgia, Inherited Erythromelalgia
- Being tested
- XPF-001, Placebo
- Medical subject headings
- Erythromelalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XPF-001Drug
Oral capsule
PlaceboDrug
Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Matching Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| XPF-001 | Experimental | Not described Receives: Drug: XPF-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary ErythromelalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xenon Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joost PH Drenth, MD PhD, Principal investigator, Radboud University Nijmegen Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090622
- Sponsor's protocol ID
- XPF-001-202
- Other IDs
- 2009-015619-42, 2009
- Status last verified
- Mar 2012
- First submitted
- 17 Mar 2010
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01090622
- Acronym / sponsor ID
- XPF-001-202
- Conditions
- Primary Erythromelalgia, Inherited Erythromelalgia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Xenon Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 22 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Matching Placebo | Placebo comparator | Drug: Placebo |
| XPF-001 | Experimental | Drug: XPF-001 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XPF-001Oral capsule | Drug | XPF-001 |
| PlaceboOral capsule | Drug | Matching Placebo |
Primary outcome
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)
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2012.
Related trials for Primary Erythromelalgia
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Spinal Cord Stimulation for Refractory Pain in Erythromelalgia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joost PH Drenth, MD PhD principal investigator
Radboud University Nijmegen Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing XPF-001 in people with Primary Erythromelalgia and Inherited Erythromelalgia, run by Xenon Pharmaceuticals Inc. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2012.