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

Allergan294 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

294

Conditions

Neuralgia, Postherpetic

Interventions

AGN-214868DRUG

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

Placebo to AGN-214868DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (4)

Unnamed facility

Orlando, Florida, United States

Unnamed facility

Brno, Czechia

Unnamed facility

Kiel, Kiel, Germany

Unnamed facility

Katowice, Poland

Outcomes

Primary Outcomes

Change From Baseline in the Average Pain Intensity Score at 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.

Time frame: Baseline, Week 12

Secondary Outcomes

Change From Baseline in Area of Spontaneous Pain

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.

Time frame: Baseline, Week 12

Change From Baseline in Area of Allodynia

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.

Time frame: Baseline, Week 12

Change From Baseline in Evoked Pain Score in the Area of Allodynia

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.

Time frame: Baseline, Week 12

Data from ClinicalTrials.gov

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