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NCT01486446 · ClinicalTrials.gov registry record · Phase 1
Phase 2a, Exploratory Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of XPF-002 in Patients With Primary/Inherited Erythromelalgia
A Phase 1 study, sponsored by Xenon Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT01486446: Completed Phase 1 study, sponsored by Xenon Pharmaceuticals.
NCT01486446 is a Phase 1 study that has completed, run by Xenon Pharmaceuticals. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01486446, a Phase 1 study, has completed, sponsored by Xenon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This is a Phase 2a single-center, randomized, double-blind, Placebo-controlled, parallel group study with XPF-002 applied twice daily over 14 or 21 days in patients with Primary/Inherited Erythromelalgia (IEM). The purpose of this study is to determine whether XPF-002 is safe and effective in the treatment of pain caused by IEM.
Primary Outcome
Using diary cards, subjects recorded the use of all non-pharmacological cooling methods used to relieve their erythromelalgia (EM) pain each day during Treatment Period 2. A smaller average number of cooling uses each day in Treatment Period 2 indicates that subjects were in less pain/required less use of cooling to relieve their EM pain and vice versa.
Interventions
- DRUG Placebo
- DRUG XPF-002
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2011-12 |
| Est. Completion | 2012-05 |
| Phase | Phase 1 |
What the finished NCT01486446 record still lists
NCT01486446 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01486446 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01486446 about?
NCT01486446 is a clinical study titled "Phase 2a, Exploratory Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of XPF-002 in Patients With Primary/Inherited Erythromelalgia". This is a Phase 2a single-center, randomized, double-blind, Placebo-controlled, parallel group study with XPF-002 applied twice daily over 14 or 21 days in patients with Primary/Inherited Erythromelalgia (IEM). The purpose of this study is to determine whether XPF-002 is safe and effective in the tr...
What is the current status of trial NCT01486446?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2011-12. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01486446?
The interventions under investigation include: Placebo (DRUG), XPF-002 (DRUG).
Who is sponsoring clinical trial NCT01486446?
This trial is sponsored by Xenon Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01486446's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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