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

Allergan

Status and phase: Completed; Phase 2

Conditions: Neuralgia, Postherpetic

Treatments: Drug: AGN-214868; Drug: Placebo to AGN-214868

Study type: Interventional

Funder types: Industry

Identifiers

NCT01129531

214868-002

Details and patient eligibility

About

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

Enrollment: 294 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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294 participants in 3 patient groups, including a placebo group

AGN-214868 3.25 μg

Experimental group

Description:

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

Treatment:

Drug: AGN-214868

AGN-214868 16.25 μg

Experimental group

Description:

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

Treatment:

Drug: AGN-214868

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo to AGN-214868