A Study Evaluating Botulinum Toxin Type A in Subjects With Postherpetic Neuralgia
Primary Purpose
Postherpetic Neuralgia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Sponsored by
About this trial
This is an interventional treatment trial for Postherpetic Neuralgia
Eligibility Criteria
Inclusion Criteria: Postherpetic neuralgia for more than 3 months after the healing of a herpes zoster skin rash. Exclusion Criteria: Previous use of botulinum toxin of any serotype or immunization to any botulinum toxin serotype.
Sites / Locations
Outcomes
Primary Outcome Measures
Pain score
Secondary Outcome Measures
Various Quality of Life questionnaires
Reduction in area of pain/allodynia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00168441
Brief Title
A Study Evaluating Botulinum Toxin Type A in Subjects With Postherpetic Neuralgia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
Brief Summary
4-month study including a 30-day baseline phase
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Primary Outcome Measure Information:
Title
Pain score
Secondary Outcome Measure Information:
Title
Various Quality of Life questionnaires
Title
Reduction in area of pain/allodynia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Postherpetic neuralgia for more than 3 months after the healing of a herpes zoster skin rash.
Exclusion Criteria:
Previous use of botulinum toxin of any serotype or immunization to any botulinum toxin serotype.
12. IPD Sharing Statement
Learn more about this trial
A Study Evaluating Botulinum Toxin Type A in Subjects With Postherpetic Neuralgia
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