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

Phase 2

Completed

• Conditions: Neuralgia, Postherpetic
• Interventions: Drug: Placebo to AGN-214868; Drug: AGN-214868

• Registration Number: NCT01129531
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-21
• Study First Submitted QC: 2010-05-21
• Study First Posted: 2010-05-24
• Study Start: 2010-06
• Primary Completion: 2011-10
• Study Completion: 2012-01
• Disposition First Submitted: 2012-10-22
• Disposition First Submitted QC: 2012-10-22
• Disposition First Posted: 2012-10-26
• Status Verified: 2013-09
• Results First Submitted: 2013-09-12
• Results First Submitted QC: 2013-09-12
• Last Update Submitted: 2013-09-12
• Results First Posted: 2013-11-15
• Last Update Posted: 2013-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo to AGN-214868	Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
AGN-214868 3.25 μg	AGN-214868	AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
AGN-214868 16.25 μg	AGN-214868	AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.