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

NCT01129531 | Completed Phase 2 Results DMC

• 1 other identifier: 214868-002
• Study Type: interventional
• Target: 294
• Locations: 4 countries
• Sites: 4

Brief Summary

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

Conditions

Neuralgia, Postherpetic

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 12

Secondary Outcomes (3)

• Change From Baseline in Area of Spontaneous Pain

  Baseline, Week 12

• Change From Baseline in Area of Allodynia

  Baseline, Week 12

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

  Baseline, Week 12

Study Arms (3)

AGN-214868 3.25 μg

EXPERIMENTAL

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

Drug: AGN-214868

AGN-214868 16.25 μg

EXPERIMENTAL

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

Drug: AGN-214868

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo to AGN-214868

Interventions

AGN-214868 DRUG

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

AGN-214868 16.25 μg; AGN-214868 3.25 μg

Placebo to AGN-214868 DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persistent postherpetic neuralgia (PHN) with nerve pain present for at least 9 months after onset of herpes zoster skin rash

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (4)

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

Brno, Czechia

Location

Unknown Facility

Kiel, Kiel, Germany

Location

Unknown Facility

Katowice, Poland

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2010
• First Posted: May 24, 2010
• Study Start: June 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: January 1, 2012
• Last Updated: November 15, 2013
• Results First Posted: November 15, 2013

Record last verified: 2013-09

Locations

DE (1); CZ (1); US (1); PL (1)