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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
Allergan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postherpetic Neuralgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 12, 2005
    Last Updated
    May 27, 2011
    Sponsor
    Allergan
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    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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