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

September 12, 2013 updated by: Allergan
This study will evaluate the safety and efficacy of AGN-214868 in patients with postherpetic neuralgia (PHN) - nerve pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

294

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AGN-214868 3.25 μg
AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
Drug: AGN-214868
AGN-214868 injected into areas of postherpetic neuralgia pain for total dose per treatment.
EXPERIMENTAL: AGN-214868 16.25 μg
AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
Drug: AGN-214868
AGN-214868 injected into areas of postherpetic neuralgia pain for total dose per treatment.
PLACEBO_COMPARATOR: Placebo
Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
Drug: Placebo to AGN-214868
Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Average Pain Intensity Score at Week 12
Time Frame: 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.
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Area of Spontaneous Pain
Time Frame: 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.
Baseline, Week 12
Change From Baseline in Area of Allodynia
Time Frame: 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.
Baseline, Week 12
Change From Baseline in Evoked Pain Score in the Area of Allodynia
Time Frame: 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.
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

May 21, 2010

First Submitted That Met QC Criteria

May 21, 2010

First Posted (ESTIMATE)

May 24, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 15, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 214868-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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