Trial · NCT01195636
A Crossover Study to Evaluate the Safety, Tolerability and Efficacy of XPF-002 in Subjects With Postherpetic Neuralgia (PHN)
NCT01195636, Phase 2, Completed, Xenon Pharmaceuticals Inc.; results first posted 2013-11-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Crossover Study to Evaluate the Safety, Tolerability and Efficacy of XPF-002 in Subjects With Postherpetic Neuralgia (PHN). Trials, record NCT01195636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01195636
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Crossover Study to Evaluate the Safety, Tolerability and Efficacy of XPF-002 in Subjects With Postherpetic Neuralgia (PHN)
- NCT number
- NCT01195636
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- Xenon Pharmaceuticals Inc.
- Conditions
- Postherpetic Neuralgia
- Interventions
- XPF-002, Placebo
- First posted
- 2010-09-06
- Last updated
- 2013-11-25
- Results first posted
- 2013-11-25
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Mean Daily Pain Score From Baseline to Week 3 (With LOCF) | 3 weeks | Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated. This measurement is the 'Change in mean daily pain score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject'. Any missing mean daily pain scores were imputed using last observation carried forward (LOCF). The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.) |
| Secondary | Change in Mean Daily Pain Score From Baseline to Week 1 | 1 week | Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated. This measurement is the 'Change in mean daily pain score from baseline between the 1st week of XPF-002 treatment and the 1st week of placebo treatment for each subject'. Missing data were not imputed. The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.) |
| Secondary | Change in Mean Daily Pain Score From Baseline to Week 2 | 2 week | Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated. This measurement is the 'Change in mean daily pain score from baseline between the 2nd week of XPF-002 treatment and the 2nd week of placebo treatment for each subject'. Missing data were not imputed. The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.) |
| Secondary | Change in Mean Daily Pain Score From Baseline to Week 3 | 3 Weeks | Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated. This measurement is the 'Change in mean daily pain score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject'. Missing data were not imputed. The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.) |
| Secondary | Proportion of Subjects Achieving at Least a 1 Point Improvement in Mean Daily Pain Score (Measured Using the 11-point Likert NRS) From Baseline to Week 3 on XPF-002 Compared to Placebo | 3 Weeks | Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated. |
| Secondary | Proportion of Subjects Achieving 50% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment | 3 weeks | |
| Secondary | Proportion of Subjects Achieving 30% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment | 3 Weeks | |
| Secondary | Proportion of Subjects Using Rescue Analgesic Medications During XPF-002 Treatment Compared to Placebo Treatment | 3 Weeks | |
| Secondary | Change in Overall Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 3 (With LOCF) | 3 Weeks | Subjects completed the NPSI questionaire at various timepoints during the study. An overall NPSI score (the sum of 10 quantitative responses, each scored 0-10, max score = 100) was calculated each time the NPSI questionaire was completed. This measurement is the 'Change in Neuropathic Pain Symptom Inventory (NPSI) score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject. If the NPSI score for Week 3 was missing, the last value from within the same treatment period was used (ie last observation carried forward (LOCF)). The reduction in NPSI on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in neuropathic pain symptoms. (A positive number would indicate neuropathic pain symptoms were increased compared to baseline.) |
| Secondary | Change in Daily Sleep Interference Scale (DSIS) From Baseline to Week 3 of XPF-002 Treatment Compared to Week 3 of Placebo Treatment (With LOCF) | 3 Weeks | Subjects recorded their sleep interference scores each morning for the previous night's sleep (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no interference with sleep and 10 = pain completely interfered with sleep). A daily sleep interference score was calculated. This measurement is the 'Change in DSIS score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject'. Any missing scores were imputed using last observation carried forward (LOCF). The reduction in DSIS on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in sleep interference due to pain. (A positive number would indicate sleep interference due to pain was increased compared to baseline.) |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Mean Daily Pain Score From Baseline to Week 3 (With LOCF) | 3 weeks | The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. The maximum number of subjects who could contribute to this population is 57.~Last Observation Carried Forward (LOCF) was used to impute any missing data. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Mean Daily Pain Score From Baseline to Week 1 | 1 week | The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Mean Daily Pain Score From Baseline to Week 2 | 2 week | The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Mean Daily Pain Score From Baseline to Week 3 | 3 Weeks | The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of Subjects Achieving at Least a 1 Point Improvement in Mean Daily Pain Score (Measured Using the 11-point Likert NRS) From Baseline to Week 3 on XPF-002 Compared to Placebo | 3 Weeks | The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis. | participants | NUMBER |
| SECONDARY | Proportion of Subjects Achieving 50% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment | 3 weeks | The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis. | participants | NUMBER |
| SECONDARY | Proportion of Subjects Achieving 30% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment | 3 Weeks | The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis. | participants | NUMBER |
| SECONDARY | Proportion of Subjects Using Rescue Analgesic Medications During XPF-002 Treatment Compared to Placebo Treatment | 3 Weeks | participants | NUMBER | |
| SECONDARY | Change in Overall Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 3 (With LOCF) | 3 Weeks | The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. The maximum number of subjects who could contribute to this population is 57.~Last Observation Carried Forward (LOCF) was used to impute any missing data. | units on a scale | MEAN |
| SECONDARY | Change in Daily Sleep Interference Scale (DSIS) From Baseline to Week 3 of XPF-002 Treatment Compared to Week 3 of Placebo Treatment (With LOCF) | 3 Weeks | The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. The maximum number of subjects who could contribute to this population is 57.~Last Observation Carried Forward (LOCF) was used to impute any missing data. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Mean Daily Pain Score From Baseline to Week 3 (With LOCF) | XPF-002 | -0.94 | 95% Confidence Interval -1.30 to -0.58 | units on a scale | |
| Change in Mean Daily Pain Score From Baseline to Week 3 (With LOCF) | Placebo | -0.97 | 95% Confidence Interval -1.33 to -0.61 | units on a scale | |
| Change in Mean Daily Pain Score From Baseline to Week 1 | XPF-002 | -0.42 | 95% Confidence Interval -0.73 to -0.11 | units on a scale | |
| Change in Mean Daily Pain Score From Baseline to Week 1 | Placebo | -0.55 | 95% Confidence Interval -0.86 to -0.24 | units on a scale | |
| Change in Mean Daily Pain Score From Baseline to Week 2 | XPF-002 | -0.74 | 95% Confidence Interval -1.07 to -0.41 | units on a scale | |
| Change in Mean Daily Pain Score From Baseline to Week 2 | Placebo | -0.70 | 95% Confidence Interval -1.03 to -0.37 | units on a scale | |
| Change in Mean Daily Pain Score From Baseline to Week 3 | XPF-002 | -0.96 | 95% Confidence Interval -1.33 to -0.58 | units on a scale | |
| Change in Mean Daily Pain Score From Baseline to Week 3 | Placebo | -0.96 | 95% Confidence Interval -1.34 to -0.59 | units on a scale | |
| Proportion of Subjects Achieving at Least a 1 Point Improvement in Mean Daily Pain Score (Measured Using the 11-point Likert NRS) From Baseline to Week 3 on XPF-002 Compared to Placebo | XPF-002 | 22 | participants | ||
| Proportion of Subjects Achieving at Least a 1 Point Improvement in Mean Daily Pain Score (Measured Using the 11-point Likert NRS) From Baseline to Week 3 on XPF-002 Compared to Placebo | Placebo | 19 | participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (3 Weeks) | STARTED | XPF-002 First, Then Placebo | 35 | |
| First Intervention (3 Weeks) | STARTED | Placebo First, Then XPF-002 | 35 | |
| First Intervention (3 Weeks) | Received at Least 1 Dose of Drug | XPF-002 First, Then Placebo | 33 | |
| First Intervention (3 Weeks) | Received at Least 1 Dose of Drug | Placebo First, Then XPF-002 | 35 | |
| First Intervention (3 Weeks) | COMPLETED | XPF-002 First, Then Placebo | 30 | |
| First Intervention (3 Weeks) | COMPLETED | Placebo First, Then XPF-002 | 32 | |
| First Intervention (3 Weeks) | NOT COMPLETED | XPF-002 First, Then Placebo | 5 | |
| First Intervention (3 Weeks) | NOT COMPLETED | Placebo First, Then XPF-002 | 3 | |
| Washout Period (2 Weeks) | STARTED | XPF-002 First, Then Placebo | 30 | |
| Washout Period (2 Weeks) | STARTED | Placebo First, Then XPF-002 | 32 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events14
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 | Application site pain | General disorders | XPF-002 | 2 | 62 | |
| other | Application site pain | General disorders | Placebo | 10 | 63 | |
| other | Application site pruritus | General disorders | XPF-002 | 2 | 62 | |
| other | Application site pruritus | General disorders | Placebo | 8 | 63 | |
| other | Application site exfoliation | General disorders | XPF-002 | 3 | 62 | |
| other | Application site exfoliation | General disorders | Placebo | 5 | 63 | |
| other | Application site rash | General disorders | XPF-002 | 4 | 62 | |
| other | Application site rash | General disorders | Placebo | 3 | 63 | |
| other | Application site erythema | General disorders | XPF-002 | 4 | 62 | |
| other | Application site erythema | General disorders | Placebo | 1 | 63 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 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 | 12 | 62 |
| Total, other adverse events | Placebo | 17 | 63 |
| Total, serious adverse events | XPF-002 | 1 | 62 |
| Total, serious adverse events | Placebo | 1 | 63 |
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| XPF-002 vs Placebo: Proportion of Subjects Using Rescue Analgesic Medications During XPF-002 Treatment Compared to Placebo Treatment | Trial comparisons |
| XPF-002 vs Placebo: Proportion of Subjects Achieving 50% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment | Trial comparisons |
XPF-002 vs Placebo: Proportion of Subjects Achieving at Least a 1 Point Improvement in Mean Daily Pain Score (Measured Using the 11-point Likert NRS) From Baseline to Week 3 on XPF-002 Compared to Placebo | Trial comparisons |
| XPF-002 vs Placebo: Proportion of Subjects Achieving 30% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment | Trial comparisons |
| XPF-002 vs Placebo: serious adverse events | 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/NCT01195636
GET https://conductscience.org/api/trials/v1/NCT01195636/registered