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

Sponsor:	Allergan
Information provided by (Responsible Party):	Allergan
ClinicalTrials.gov Identifier:	NCT01129531

Purpose

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

Condition	Intervention	Phase
Neuralgia, Postherpetic	Drug: AGN-214868 Drug: AGN-214868 Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Shingles

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Patient-reported Pain Intensity Score using a numerical rating scale [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Area of spontaneous pain [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Area of allodynia [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Evoked pain score in area of allodynia [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Health Outcomes Questionnaires [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment:	294
Study Start Date:	June 2010
Study Completion Date:	January 2012
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 AGN-214868 total dose 3250 ng	Drug: AGN-214868 AGN-214868 injected into areas of postherpetic neuralgia pain for total dose of 3250 ng per treatment. Patients will receive two treatments 12 weeks apart
Experimental: 2 AGN-214868 total dose 16250 ng	Drug: AGN-214868 AGN-214868 injected into areas of postherpetic neuralgia pain for total dose of 16250 ng per treatment. Patients will receive two treatments 12 weeks apart.
Placebo Comparator: 3 AGN-214868 placebo	Drug: AGN-214868 Placebo AGN-214868 Placebo injected into areas of postherpetic neuralgia pain per treatment. Patients will receive two treatments 12 weeks apart

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129531

Locations

United States, Florida

Orlando, Florida, United States
Czech Republic

Hradec kralove, Czech Republic
Germany

Kiel, Germany
Poland

Katowice, Poland

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT01129531 History of Changes
Other Study ID Numbers:	214868-002
Study First Received:	May 21, 2010
Last Updated:	May 15, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations

Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2012