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

Allergan

Status and phase: Terminated; Phase 2

Conditions: Neuralgia, Postherpetic

Treatments: Drug: AGN-214868 Placebo (Vehicle); Drug: AGN-214868

Study type: Interventional

Funder types: Industry

Identifiers

NCT01678924

214868-007

2012-002240-24 (EudraCT Number)

Details and patient eligibility

About

This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia (PHN).

Enrollment: 280 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postherpetic neuralgia with pain present for at least 9 months

Exclusion criteria

• Active herpes zoster skin rash
• Anticipated treatment for postherpetic neuralgia during the first 3 months of the study, including oral and topical medications, acupuncture, spinal cord stimulation, transcutaneous nerve stimulation (TNS), or trigger point injection
• Anticipated treatment with pain medication for the treatment of postherpetic neuralgia during the first 3 months of the study
• Use of capsaicin treatment for postherpetic neuralgia within 6 months, or anticipated use during the first 3 months of the study
• Use of botulinum toxin of any serotype for any reason within 6 months, or anticipated use during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 4 patient groups, including a placebo group

AGN-214868 Dose 1

Experimental group

Description:

AGN-214868 Dose 1 given as injections into the area of pain on Day 1.

Treatment:

Drug: AGN-214868

AGN-214868 Dose 2

Experimental group

Description:

AGN-214868 Dose 2 given as injections into the area of pain on Day 1.

Treatment:

Drug: AGN-214868

AGN-214868 Placebo (Vehicle)

Placebo Comparator group

Description:

AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.

Treatment:

Drug: AGN-214868 Placebo (Vehicle)

AGN-214868 Dose 3

Experimental group

Description:

AGN-214868 Dose 3 given as injections into the area of pain on Day 1.

Treatment:

Drug: AGN-214868