Trial · NCT01486446
Phase 2a, Exploratory Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of XPF-002 in Patients With Primary/Inherited Erythromelalgia
NCT01486446, Phase 1, Phase 2, Completed, Xenon Pharmaceuticals Inc.; results first posted 2014-04-14
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Phase 2a, Exploratory Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of XPF-002 in Patients With Primary/Inherited Erythromelalgia. Trials, record NCT01486446. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01486446
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2a, Exploratory Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of XPF-002 in Patients With Primary/Inherited Erythromelalgia
- NCT number
- NCT01486446
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Xenon Pharmaceuticals Inc.
- Conditions
- Primary Erythromelalgia, Inherited Erythromelalgia
- Interventions
- XPF-002, Placebo
- First posted
- 2011-12-06
- Last updated
- 2014-04-14
- Results first posted
- 2014-04-14
- Limitations and caveats
This was a small trial with many exploratory efficacy measures. There was no primary outcome measure, all measures are other: pre-specified.~Only 8 subjects were enrolled (1 placebo), the actual number of Adverse Events is used, not incidence.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Daily Use of Cooling for Erythromelalgia-Related Pain in Treatment Period 2 | 14-21 Days | 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. |
| Other | Average Cooling Duration (Minutes Per Day) for EM-related Pain in Treatment Period 2 | 14-21 Days | Using diary cards, subjects recorded the use and duration of all non-pharmacological cooling methods used to relieve their EM pain each day during Treatment Period 2. A smaller average duration of cooling 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. |
| Other | Time to Exit (Minutes) From Standard Heat Inductions in Treatment Period 1, Compared to Baseline | Baseline to Day 5 | A standard heat induction was performed on multiple occasions pre-and post treatment. Subjects placed their feet in front of an electric heater for up to 75 minutes. Subjects rated their pain intensity/severity using numerical and categorical rating scales at fixed intervals before, during and after the heating procedure. The heating procedure continued until one of the pre-defined stopping criteria were met, or when the 75 minutes were over. Subjects could stop the procedure at any time if pain was intolerable. A stopwatch was used to record the time the heating procedure was stopped. This time is known as "Time to Exit". A longer Time to Exit compared to Baseline indicates that subjects were able to tolerate the heat for a longer period when on treatment. |
| Other | Time to Exit (Minutes) From Standard Heat Inductions in Treatment Period 2, Compared to Baseline | Baseline and 14 or 21 days | A standard heat induction was performed on multiple occasions pre-and post treatment. Subjects placed their feet in front of an electric heater for up to 75 minutes. Subjects rated their pain intensity/severity using numerical and categorical rating scales at fixed intervals before, during and after the heating procedure. The heating procedure continued until one of the pre-defined stopping criteria were met, or when the 75 minutes were over. Subjects could stop the procedure at any time if pain was intolerable. A stopwatch was used to record the time the heating procedure was stopped. This time is known as "Time to Exit". A longer Time to Exit compared to Baseline indicates that subjects were able to tolerate the heat for a longer period when on treatment. |
| Other | Time to Moderate Pain (Minutes) During Standard Heat Inductions in Treatment Period 1, Compared to Baseline | Baseline to Day 5 | A standard heat induction was performed on multiple occasions pre-and post treatment. Subjects placed their feet in front of an electric heater for up to 75 minutes. Subjects rated their pain intensity/severity using numerical and categorical rating scales at fixed intervals before, during and after the heating procedure. The heating procedure continued until one of the pre-defined stopping criteria were met, or when the 75 minutes were over. Subjects could stop the procedure at any time if pain was intolerable. A stopwatch was used to record the time the subject recorded a pain intensity numerical score of 5 or more (on a scale of 0-10). This time is known as "Time to Moderate Pain". A longer Time to Moderate Pain compared to Baseline indicates that subjects were able to tolerate the heat for a longer period when on treatment. |
| Other | Time to Moderate Pain (Minutes) During Standard Heat Inductions in Treatment Period 2, Compared to Baseline | Baseline and 14 or 21 days | A standard heat induction was performed on multiple occasions pre-and post treatment. Subjects placed their feet in front of an electric heater for up to 75 minutes. Subjects rated their pain intensity/severity using numerical and categorical rating scales at fixed intervals before, during and after the heating procedure. The heating procedure continued until one of the pre-defined stopping criteria were met, or when the 75 minutes were over. Subjects could stop the procedure at any time if pain was intolerable. A stopwatch was used to record the time the subject recorded a pain intensity numerical score of 5 or more (on a scale of 0-10). This time is known as "Time to Moderate Pain". A longer Time to Moderate Pain compared to Baseline indicates that subjects were able to tolerate the heat for a longer period when on treatment. |
| Other | Daily Pain (Maximum Pain Intensity) in Treatment Period 2, Compared to Baseline | Baseline to 14 or 21 days | During Baseline and Treatment Period 2, subjects recorded pain scores in their diary cards 3 times each day (upon waking, lunchtime and evening). On each recording occasion, subjects recorded the maximum pain experienced since the previous recording occasion using an 11 point numerical rating scale of pain intensity, PINRS (where 0 = no pain and 10 = worst pain imaginable). A lower score compared to Baseline indicates that the subjects experienced less severe pain on treatment than during Baseline. |
| Other | Sleep Interference Due to Pain in Treatment Period 2, Compared to Baseline | Baseline to 14 or 21 days | During Baseline and Treatment Period 2, subjects recorded sleep interference scores in their diary cards for each night (scores were recorded upon waking). Sleep Interference due to pain is scored using an 11 point numerical rating scale where 0 = pain does not interfere with sleep and 10 = completely interferes, unable to sleep due to pain. A lower sleep interference score compared to Baseline indicates that the subjects' pain interfered with sleep less on treatment than during Baseline. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| OTHER_PRE_SPECIFIED | Average Cooling Duration (Minutes Per Day) for EM-related Pain in Treatment Period 2 | 14-21 Days | minutes/day | MEAN | |
| OTHER_PRE_SPECIFIED | Time to Exit (Minutes) From Standard Heat Inductions in Treatment Period 1, Compared to Baseline | Baseline to Day 5 | Percentage of Baseline | MEAN | |
| PRIMARY | Average Daily Use of Cooling for Erythromelalgia-Related Pain in Treatment Period 2 | 14-21 Days | cooling uses/day | MEAN | |
| OTHER_PRE_SPECIFIED | Time to Exit (Minutes) From Standard Heat Inductions in Treatment Period 2, Compared to Baseline | Baseline and 14 or 21 days | Percentage of Baseline | MEAN | |
| OTHER_PRE_SPECIFIED | Time to Moderate Pain (Minutes) During Standard Heat Inductions in Treatment Period 1, Compared to Baseline | Baseline to Day 5 | Percentage of Baseline | MEAN | |
| OTHER_PRE_SPECIFIED | Time to Moderate Pain (Minutes) During Standard Heat Inductions in Treatment Period 2, Compared to Baseline | Baseline and 14 or 21 days | Percentage of Baseline | MEAN | |
| OTHER_PRE_SPECIFIED | Daily Pain (Maximum Pain Intensity) in Treatment Period 2, Compared to Baseline | Baseline to 14 or 21 days | Percentage of Baseline | MEAN | |
| OTHER_PRE_SPECIFIED | Sleep Interference Due to Pain in Treatment Period 2, Compared to Baseline | Baseline to 14 or 21 days | Percentage of Baseline | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Cooling Duration (Minutes Per Day) for EM-related Pain in Treatment Period 2 | XPF-002 | 7.8 | Inter-Quartile Range 0 to 13.3 | minutes/day | |
| Average Cooling Duration (Minutes Per Day) for EM-related Pain in Treatment Period 2 | Placebo | 86 | Inter-Quartile Range NA to NA | minutes/day | |
| Time to Exit (Minutes) From Standard Heat Inductions in Treatment Period 1, Compared to Baseline | XPF-002 | 138 | Inter-Quartile Range 78 to 188 | Percentage of Baseline | |
| Time to Exit (Minutes) From Standard Heat Inductions in Treatment Period 1, Compared to Baseline | Placebo | 96 | Inter-Quartile Range NA to NA | Percentage of Baseline | |
| Average Daily Use of Cooling for Erythromelalgia-Related Pain in Treatment Period 2 | XPF-002 | 0.24 | Inter-Quartile Range 0.03 to 0.27 | cooling uses/day | |
| Average Daily Use of Cooling for Erythromelalgia-Related Pain in Treatment Period 2 | Placebo | 2.4 | Inter-Quartile Range NA to NA | cooling uses/day | |
| Time to Exit (Minutes) From Standard Heat Inductions in Treatment Period 2, Compared to Baseline | XPF-002 | 100 | Inter-Quartile Range 92 to 112 | Percentage of Baseline | |
| Time to Exit (Minutes) From Standard Heat Inductions in Treatment Period 2, Compared to Baseline | Placebo | 107 | Inter-Quartile Range NA to NA | Percentage of Baseline | |
| Time to Moderate Pain (Minutes) During Standard Heat Inductions in Treatment Period 1, Compared to Baseline | XPF-002 | 137 | Inter-Quartile Range 74 to 172 | Percentage of Baseline | |
| Time to Moderate Pain (Minutes) During Standard Heat Inductions in Treatment Period 1, Compared to Baseline | Placebo | 90 | Inter-Quartile Range NA to NA | Percentage of Baseline |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | XPF-002 | 7 | |
| Overall Study | STARTED | Placebo | 1 | |
| Overall Study | COMPLETED | XPF-002 | 6 | |
| Overall Study | COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | XPF-002 | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events54
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | XPF-002 | 3 | 7 | 8 |
| other | Headache | Nervous system disorders | Placebo | 0 | 1 | 0 |
| other | Paraesthesia | Nervous system disorders | XPF-002 | 2 | 7 | 3 |
| other | Paraesthesia | Nervous system disorders | Placebo | 0 | 1 | 0 |
| other | Burning sensation | Nervous system disorders | XPF-002 | 1 | 7 | 1 |
| other | Burning sensation | Nervous system disorders | Placebo | 0 | 1 | 0 |
| other | Sinus headache | Nervous system disorders | XPF-002 | 1 | 7 | 1 |
| other | Sinus headache | Nervous system disorders | Placebo | 0 | 1 | 0 |
| other | Nodule | General disorders | XPF-002 | 1 | 7 | 4 |
| other | Nodule | General disorders | Placebo | 0 | 1 | 0 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | XPF-002 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | XPF-002 | 7 | 7 |
| Total, other adverse events | Placebo | 1 | 1 |
| Total, serious adverse events | XPF-002 | 1 | 7 |
| Total, serious adverse events | Placebo | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| XPF-002 vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01486446
GET https://conductscience.org/api/trials/v1/NCT01486446/events?page=2