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

NCT ID: NCT01129531

Last Updated: 2013-11-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

294 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-01-31

Brief Summary

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This study will evaluate the safety and efficacy of AGN-214868 in patients with postherpetic neuralgia (PHN) - nerve pain.

Detailed Description

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Conditions

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Neuralgia, Postherpetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AGN-214868 3.25 μg

AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.

Group Type EXPERIMENTAL

AGN-214868

Intervention Type DRUG

AGN-214868 injected into areas of postherpetic neuralgia pain for total dose per treatment.

AGN-214868 16.25 μg

AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.

Group Type EXPERIMENTAL

AGN-214868

Intervention Type DRUG

AGN-214868 injected into areas of postherpetic neuralgia pain for total dose per treatment.

Placebo

Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.

Group Type PLACEBO_COMPARATOR

Placebo to AGN-214868

Intervention Type DRUG

Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.

Interventions

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AGN-214868

AGN-214868 injected into areas of postherpetic neuralgia pain for total dose per treatment.

Intervention Type DRUG

Placebo to AGN-214868

Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Persistent postherpetic neuralgia (PHN) with nerve pain present for at least 9 months after onset of herpes zoster skin rash

Exclusion Criteria

* Female patients with reproductive potential
* Active herpes zoster skin rash
* Current or anticipated treatment with acupuncture, TNS, or steroids
* Current or anticipated use of topical analgesic agents with PHN
* Treatment with botulinum toxin therapy of any serotype within the prior 12 weeks
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Orlando, Florida, United States

Site Status

Brno, , Czechia

Site Status

Kiel, Kiel, Germany

Site Status

Katowice, , Poland

Site Status

Countries

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United States Czechia Germany Poland

Other Identifiers

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214868-002

Identifier Type: -

Identifier Source: org_study_id