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

This study has suspended participant recruitment.
(Pending availability of clinical supplies)
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01678924
First received: August 31, 2012
Last updated: May 8, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Neuralgia, Postherpetic
 Drug: AGN-214868
Drug: AGN-214868 Placebo (Vehicle)
 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:
  • Change from Baseline in Average Pain Intensity Score [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Average Pain Intensity Score Responders [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Maximal Area of Spontaneous Pain [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Area of Allodynia [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Evoked Pain Score in the Area of Allodynia [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Itch Severity Score [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Daily Sleep Interference Scale Score [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Neuropathic Pain Symptom Inventory Score [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AGN-214868 Dose 1
AGN-214868 Dose 1 given as injections into the area of pain on Day 1.
 Drug: AGN-214868
AGN-214868 given as injections into the area of pain on Day 1.
Experimental: AGN-214868 Dose 2
AGN-214868 Dose 2 given as injections into the area of pain on Day 1.
 Drug: AGN-214868
AGN-214868 given as injections into the area of pain on Day 1.
Placebo Comparator: AGN-214868 Placebo (Vehicle)
AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.
 Drug: AGN-214868 Placebo (Vehicle)
AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 study, including oral and topical medications, acupuncture, transcutaneous nerve stimulation (TNS), or trigger point injection
  • Anticipated treatment with pain medication for the treatment of postherpetic neuralgia during the study
  • Use of capsaicin treatment for postherpetic neuralgia within 6 months, or anticipated use during the study
  • Use of botulinum toxin of any serotype for any reason within 6 months, or anticipated use during the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678924

Locations
United States, Colorado
Boulder, Colorado, United States
Australia, South Australia
Adelaide, South Australia, Australia
Czech Republic
Brno, Czech Republic
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Additional Information:
More information  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01678924     History of Changes
Other Study ID Numbers: 214868-007, 2012-002240-24
Study First Received: August 31, 2012
Last Updated: May 8, 2013
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 16, 2013