Back to resultsA Study of the Safety and Efficacy of AGN-214868 in Patients With Postherpetic Neuralgia
Primary Purpose
Neuralgia, Postherpetic
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AGN-214868
Placebo to AGN-214868
Sponsored by
About this trial
This is an interventional treatment trial for Neuralgia, Postherpetic
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
AGN-214868 3.25 μg
AGN-214868 16.25 μg
Placebo
Arm Description
AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
Outcomes
Primary Outcome Measures
Change From Baseline in the Average Pain Intensity Score at Week 12
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01129531
Brief Title
A Study of the Safety and Efficacy of AGN-214868 in Patients With Postherpetic Neuralgia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate the safety and efficacy of AGN-214868 in patients with postherpetic neuralgia (PHN) - nerve pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia, Postherpetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
294 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AGN-214868 3.25 μg
Arm Type
Experimental
Arm Description
AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
Arm Title
AGN-214868 16.25 μg
Arm Type
Experimental
Arm Description
AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
Intervention Type
Drug
Intervention Name(s)
AGN-214868
Intervention Description
AGN-214868 injected into areas of postherpetic neuralgia pain for total dose per treatment.
Intervention Type
Drug
Intervention Name(s)
Placebo to AGN-214868
Intervention Description
Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
Primary Outcome Measure Information:
Title
Change From Baseline in the Average Pain Intensity Score at Week 12
Description
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.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Area of Spontaneous Pain
Description
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.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Area of Allodynia
Description
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.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Evoked Pain Score in the Area of Allodynia
Description
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.
Time Frame
Baseline, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Orlando
State/Province
Florida
Country
United States
City
Brno
Country
Czech Republic
City
Kiel
Country
Germany
City
Katowice
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
A Study of the Safety and Efficacy of AGN-214868 in Patients With Postherpetic Neuralgia
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