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: September 12, 2013
Last verified: September 2013
  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: Placebo to AGN-214868
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 the Average Pain Intensity Score at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Participants rated the severity of their daily pain in the previous 7 days using a 10 point scale where 0=no pain to 10=pain as bad as you can imagine. A negative change from Baseline indicated improvement.


Secondary Outcome Measures:
  • Change From Baseline in Area of Spontaneous Pain [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    A tracing of the area of spontaneous pain was made and sent to an independent central reading center for measurement. The area of spontaneous pain was measured in centimeters squared (cm^2) at Baseline and Week 12. A negative change from Baseline indicated improvement.

  • Change From Baseline in Area of Allodynia [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    A tracing of the area of allodynia (pain to touch) was made and sent to an independent central reading center for measurement. The area of allodynia was measured in centimeters squared (cm^2) at Baseline and Week 12. A negative change from Baseline indicated improvement.

  • Change From Baseline in Evoked Pain Score in the Area of Allodynia [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Participants were asked to rate the unpleasantness (pain to touch) after 3 brush strokes in the area of allodynia on a 100 point scale where 0=no pain to 100=worst pain imaginable. A negative change from Baseline indicated improvement.


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: AGN-214868 3.25 μg
AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
Drug: AGN-214868
AGN-214868 injected into areas of postherpetic neuralgia pain for total dose per treatment.
Experimental: AGN-214868 16.25 μg
AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
Drug: AGN-214868
AGN-214868 injected into areas of postherpetic neuralgia pain for total dose per treatment.
Placebo Comparator: Placebo
Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
Drug: Placebo to AGN-214868
Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.

  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
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: NCT01129531

Locations
United States, Florida
Orlando, Florida, United States
Czech Republic
Brno, 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
Results First Received: September 12, 2013
Last Updated: September 12, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014