Trial · NCT01129531

A Study of the Safety and Efficacy of AGN-214868 in Patients With Postherpetic Neuralgia

NCT01129531, Phase 2, Completed, Allergan; results first posted 2013-11-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of the Safety and Efficacy of AGN-214868 in Patients With Postherpetic Neuralgia. Trials, record NCT01129531. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01129531

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of the Safety and Efficacy of AGN-214868 in Patients With Postherpetic Neuralgia
NCT number: NCT01129531
Status: Completed
Phases: Phase 2
Enrollment: 294 participants, actual
Lead sponsor: Allergan
Conditions: Neuralgia, Postherpetic
Interventions: AGN-214868, Placebo to AGN-214868
First posted: 2010-05-24
Last updated: 2013-11-15
Results first posted: 2013-11-15

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in the Average Pain Intensity Score at Week 12	Baseline, Week 12	Participants rated the severity of their daily pain in the previous 7 days using a 10 point scale where 0=no pain to 10=pain as bad as you can imagine. A negative change from Baseline indicated improvement.
Secondary	Change From Baseline in Area of Spontaneous Pain	Baseline, Week 12	A tracing of the area of spontaneous pain was made and sent to an independent central reading center for measurement. The area of spontaneous pain was measured in centimeters squared (cm\^2) at Baseline and Week 12. A negative change from Baseline indicated improvement.
Secondary	Change From Baseline in Area of Allodynia	Baseline, Week 12	A tracing of the area of allodynia (pain to touch) was made and sent to an independent central reading center for measurement. The area of allodynia was measured in centimeters squared (cm\^2) at Baseline and Week 12. A negative change from Baseline indicated improvement.
Secondary	Change From Baseline in Evoked Pain Score in the Area of Allodynia	Baseline, Week 12	Participants were asked to rate the unpleasantness (pain to touch) after 3 brush strokes in the area of allodynia on a 100 point scale where 0=no pain to 100=worst pain imaginable. A negative change from Baseline indicated improvement.

Source ClinicalTrials.gov

Outcomes4

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 the Average Pain Intensity Score at Week 12	Baseline, Week 12	Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.	Score on a scale	MEAN
SECONDARY	Change From Baseline in Area of Spontaneous Pain	Baseline, Week 12	Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.	cm^2	MEAN
SECONDARY	Change From Baseline in Area of Allodynia	Baseline, Week 12	Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.	cm^2	MEAN
SECONDARY	Change From Baseline in Evoked Pain Score in the Area of Allodynia	Baseline, Week 12	Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.	Score on a scale	MEAN

Source ClinicalTrials.gov

Results by group24

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 the Average Pain Intensity Score at Week 12	AGN-214868 3.25 μg	Baseline	6.13	Standard Deviation 1.248	Score on a scale
Change From Baseline in the Average Pain Intensity Score at Week 12	AGN-214868 16.25 μg	Baseline	6.04	Standard Deviation 1.324	Score on a scale
Change From Baseline in the Average Pain Intensity Score at Week 12	Placebo	Baseline	6.05	Standard Deviation 1.334	Score on a scale
Change From Baseline in the Average Pain Intensity Score at Week 12	AGN-214868 3.25 μg	Change from Baseline at Week 12	-1.42	Standard Deviation 1.876	Score on a scale
Change From Baseline in the Average Pain Intensity Score at Week 12	AGN-214868 16.25 μg	Change from Baseline at Week 12	-1.35	Standard Deviation 1.996	Score on a scale
Change From Baseline in the Average Pain Intensity Score at Week 12	Placebo	Change from Baseline at Week 12	-1.27	Standard Deviation 2.036	Score on a scale
Change From Baseline in Area of Spontaneous Pain	AGN-214868 3.25 μg	Baseline	87.44	Standard Deviation 51.312	cm^2
Change From Baseline in Area of Spontaneous Pain	AGN-214868 16.25 μg	Baseline	118.17	Standard Deviation 74.858	cm^2
Change From Baseline in Area of Spontaneous Pain	Placebo	Baseline	98.27	Standard Deviation 62.866	cm^2
Change From Baseline in Area of Spontaneous Pain	AGN-214868 3.25 μg	Change from Baseline at Week 12 (N=81, 79, 117)	-4.83	Standard Deviation 62.374	cm^2

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Cycle 1	STARTED	AGN-214868 3.25 μg	84
Treatment Cycle 1	STARTED	AGN-214868 16.25 μg	84
Treatment Cycle 1	STARTED	Placebo	126
Treatment Cycle 1	COMPLETED	AGN-214868 3.25 μg	80
Treatment Cycle 1	COMPLETED	AGN-214868 16.25 μg	78
Treatment Cycle 1	COMPLETED	Placebo	110
Treatment Cycle 1	NOT COMPLETED	AGN-214868 3.25 μg	4
Treatment Cycle 1	NOT COMPLETED	AGN-214868 16.25 μg	6
Treatment Cycle 1	NOT COMPLETED	Placebo	16
Treatment Cycle 2	STARTED	AGN-214868 3.25 μg	94

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events144

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
other	Arthralgia	Musculoskeletal and connective tissue disorders	AGN-214868 3.25 μg_Cycle 1	1	84
other	Arthralgia	Musculoskeletal and connective tissue disorders	AGN-214868 16.25 μg_Cycle 1	1	83
other	Arthralgia	Musculoskeletal and connective tissue disorders	Placebo_Cycle 1	2	125
other	Arthralgia	Musculoskeletal and connective tissue disorders	AGN-214868 3.25 μg_ Cycle 2	6	94
other	Arthralgia	Musculoskeletal and connective tissue disorders	AGN-214868 16.25 μg_ Cycle 2	1	95
other	Arthralgia	Musculoskeletal and connective tissue disorders	Placebo_Cycle 2	3	79
serious	Cardiac failure chronic	Cardiac disorders	AGN-214868 3.25 μg_Cycle 1	1	84
serious	Cardiac failure chronic	Cardiac disorders	AGN-214868 16.25 μg_Cycle 1	0	83
serious	Cardiac failure chronic	Cardiac disorders	Placebo_Cycle 1	0	125
serious	Cardiac failure chronic	Cardiac disorders	AGN-214868 3.25 μg_ Cycle 2	0	94

1 to 10 of 144Source ClinicalTrials.gov

See all 144 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AGN-214868 3.25 μg_Cycle 1
Total, all-cause mortality	AGN-214868 16.25 μg_Cycle 1
Total, all-cause mortality	Placebo_Cycle 1
Total, all-cause mortality	AGN-214868 3.25 μg_ Cycle 2
Total, all-cause mortality	AGN-214868 16.25 μg_ Cycle 2
Total, all-cause mortality	Placebo_Cycle 2
Total, other adverse events	AGN-214868 3.25 μg_Cycle 1	1	84
Total, other adverse events	AGN-214868 16.25 μg_Cycle 1	1	83
Total, other adverse events	Placebo_Cycle 1	2	125
Total, other adverse events	AGN-214868 3.25 μg_ Cycle 2	6	94

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

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 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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