Trial · NCT01678924
A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia
NCT01678924, Phase 2, Terminated, Allergan; results first posted 2020-01-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia. Trials, record NCT01678924. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01678924
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia
- NCT number
- NCT01678924
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 280 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Neuralgia, Postherpetic
- Interventions
- AGN-214868, AGN-214868 Placebo (Vehicle)
- First posted
- 2012-09-05
- Last updated
- 2020-01-07
- Other registries' IDs
- eudract:2012-002240-24
- Results first posted
- 2020-01-07
Source ClinicalTrials.gov
Registered outcomes50
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Baseline to Week 12 | The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient's eDiary during each 7-day period, starting with the day of study treatment injection. Patients used the 11-point Likert scale, with anchors at 0 = "no pain" and 10 = "pain as bad as you can imagine" Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment. |
| Primary | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Baseline to Week 12 | The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient's eDiary during each 7-day period, starting with the day of study treatment injection. patients used the 11-point Likert scale, with anchors at 0 = "no pain" and 10 = "pain as bad as you can imagine" Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment. |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1 | Baseline to Week 1 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2 | Baseline to Week 2 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3 | Baseline to Week 3 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4 | Baseline to Week 4 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease), and in 10% increments, up to 100% improvement, in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5 | Baseline to Week 5 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 6 | Baseline to Week 6 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 7 | Baseline to Week 7 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 8 | Baseline to Week 8 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 registered outcomesOutcomes50
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Baseline to Week 12 | Two cohorts of patients with postherpetic neuralgia (PHN) were randomized to receive 1 treatment of either AGN-214868 (cohort 1: 32.5 or 65 μg; cohort 2: 130 μg) or placebo. Cohort 1 includes 154 patients from the modified intent to treat (mITT) population | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Baseline to Week 12 | Two cohorts of patients with postherpetic neuralgia (PHN) were randomized to receive 1 treatment of either AGN-214868 (cohort 1: 32.5 or 65 μg; cohort 2: 130 μg) or placebo. Cohort 2 includes 125 patients from the mITT population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1 | Baseline to Week 1 | The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population | percentage of patients | NUMBER |
| SECONDARY | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2 | Baseline to Week 2 | The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population | percentage of patients | NUMBER |
| SECONDARY | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3 | Baseline to Week 3 | The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population | percentage of patients | NUMBER |
| SECONDARY | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4 | Baseline to Week 4 | The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population | percentage of patients | NUMBER |
| SECONDARY | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5 | Baseline to Week 5 | The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population | percentage of patients | NUMBER |
| SECONDARY | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 6 | Baseline to Week 6 | The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population | percentage of patients | NUMBER |
| SECONDARY | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 7 | Baseline to Week 7 | The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population | percentage of patients | NUMBER |
| SECONDARY | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 8 | Baseline to Week 8 | The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population | percentage of patients | NUMBER |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 outcomesResults by group180
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Average Pain Intensity Score - Cohort 1 | AGN 214868 65µg | Week 1 | -0.88 | 95% Confidence Interval -1.249 to -0.538 | units on a scale |
| Change From Baseline in Average Pain Intensity Score - Cohort 1 | AGN 214868 32.5µg | Week 1 | -1.02 | 95% Confidence Interval -1.380 to -0.587 | units on a scale |
| Change From Baseline in Average Pain Intensity Score - Cohort 1 | Placebo | Week 1 | -1.11 | 95% Confidence Interval -1.425 to -0.808 | units on a scale |
| Change From Baseline in Average Pain Intensity Score - Cohort 1 | AGN 214868 65µg | Week 2 | -1.33 | 95% Confidence Interval -1.746 to -0.968 | units on a scale |
| Change From Baseline in Average Pain Intensity Score - Cohort 1 | AGN 214868 32.5µg | Week 2 | -1.56 | 95% Confidence Interval -1.963 to -1.017 | units on a scale |
| Change From Baseline in Average Pain Intensity Score - Cohort 1 | Placebo | Week 2 | -1.57 | 95% Confidence Interval -1.970 to -1.174 | units on a scale |
| Change From Baseline in Average Pain Intensity Score - Cohort 1 | AGN 214868 65µg | Week 3 | -1.66 | 95% Confidence Interval -2.143 to -1.203 | units on a scale |
| Change From Baseline in Average Pain Intensity Score - Cohort 1 | AGN 214868 32.5µg | Week 3 | -1.93 | 95% Confidence Interval -2.426 to -1.227 | units on a scale |
| Change From Baseline in Average Pain Intensity Score - Cohort 1 | Placebo | Week 3 | -1.84 | 95% Confidence Interval -2.248 to -1.388 | units on a scale |
| Change From Baseline in Average Pain Intensity Score - Cohort 1 | AGN 214868 65µg | Week 4 | -1.78 | 95% Confidence Interval -2.277 to -1.310 | units on a scale |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AGN 214868 130µg | 64 | |
| Overall Study | STARTED | AGN 214868 65µg | 63 | |
| Overall Study | STARTED | AGN 214868 32.5µg | 30 | |
| Overall Study | STARTED | Placebo | 123 | |
| Overall Study | COMPLETED | AGN 214868 130µg | 54 | |
| Overall Study | COMPLETED | AGN 214868 65µg | 51 | |
| Overall Study | COMPLETED | AGN 214868 32.5µg | 28 | |
| Overall Study | COMPLETED | Placebo | 105 | |
| Overall Study | NOT COMPLETED | AGN 214868 130µg | 10 | |
| Overall Study | NOT COMPLETED | AGN 214868 65µg | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events128
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 | Injection site pain | General disorders | AGN 214868 130µg | 6 | 64 | |
| other | Injection site pain | General disorders | AGN 214868 65µg | 1 | 63 | |
| other | Injection site pain | General disorders | AGN 214868 32.5µg | 0 | 30 | |
| other | Injection site pain | General disorders | Placebo | 6 | 123 | |
| other | Upper respiratory tract infection | Infections and infestations | AGN 214868 130µg | 4 | 64 | |
| other | Upper respiratory tract infection | Infections and infestations | AGN 214868 65µg | 5 | 63 | |
| other | Upper respiratory tract infection | Infections and infestations | AGN 214868 32.5µg | 1 | 30 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 8 | 123 | |
| other | Nasopharyngitis | Infections and infestations | AGN 214868 130µg | 3 | 64 | |
| other | Nasopharyngitis | Infections and infestations | AGN 214868 65µg | 5 | 63 |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AGN 214868 130µg | ||
| Total, all-cause mortality | AGN 214868 65µg | ||
| Total, all-cause mortality | AGN 214868 32.5µg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | AGN 214868 130µg | 15 | 64 |
| Total, other adverse events | AGN 214868 65µg | 15 | 63 |
| Total, other adverse events | AGN 214868 32.5µg | 8 | 30 |
| Total, other adverse events | Placebo | 30 | 123 |
| Total, serious adverse events | AGN 214868 130µg | 2 | 64 |
| Total, serious adverse events | AGN 214868 65µg | 8 | 63 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01678924
GET https://conductscience.org/api/trials/v1/NCT01678924/registered?page=2