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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01129531
First received: May 21, 2010
Last updated: October 22, 2012
Last verified: October 2012
History of Changes
  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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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: October 22, 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 19, 2013