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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01678924
First Posted: September 5, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Percentage of Average Pain Intensity Score Responders [ Time Frame: 12 Weeks ]
  • Change from Baseline in Maximal Area of Spontaneous Pain [ Time Frame: Baseline, 12 Weeks ]
  • Change from Baseline in Area of Allodynia [ Time Frame: Baseline, 12 Weeks ]
  • Change from Baseline in Evoked Pain Score in the Area of Allodynia [ Time Frame: Baseline, 12 Weeks ]

Enrollment: 282
Study Start Date: January 2013
Study Completion Date: September 2015
Primary Completion Date: May 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678924


Locations
United States, Colorado
Boulder, Colorado, United States
Austria
Vienna, Austria
Germany
Frankfurt, Germany
Poland
Katowice, Poland
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01678924     History of Changes
Other Study ID Numbers: 214868-007
2012-002240-24 ( EudraCT Number )
First Submitted: August 31, 2012
First Posted: September 5, 2012
Last Update Posted: October 12, 2017
Last Verified: October 2015

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms