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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01678924
First received: August 31, 2012
Last updated: September 12, 2014
Last verified: September 2014
  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:


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 ]

Estimated Enrollment: 270
Study Start Date: January 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: September 2015 (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.
Experimental: AGN-214868 Dose 3
AGN-214868 Dose 3 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.

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678924

Contacts
Contact: Allergan Inc. clinicaltrials@allergan.com

Locations
United States, Colorado
Recruiting
Boulder, Colorado, United States
Australia, South Australia
Withdrawn
Adelaide, South Australia, Australia
Austria
Recruiting
Vienna, Austria
Czech Republic
Withdrawn
Brno, Czech Republic
Germany
Recruiting
Frankfurt, Germany
Poland
Recruiting
Katowice, Poland
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Additional Information:
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: September 12, 2014
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 September 18, 2014