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A Study Evaluating Botulinum Toxin Type A in Subjects With Postherpetic Neuralgia

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00168441
First received: September 12, 2005
Last updated: May 27, 2011
Last verified: May 2011
History of Changes
  Purpose

4-month study including a 30-day baseline phase


Condition Intervention Phase
Postherpetic Neuralgia
 Drug: Botulinum Toxin Type A
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Botox Shingles
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Pain score

Secondary Outcome Measures:
  • Various Quality of Life questionnaires
  • Reduction in area of pain/allodynia

Enrollment: 117
Study Start Date: June 2004
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Therapeutic Area Head, Allergan, Inc
ClinicalTrials.gov Identifier: NCT00168441     History of Changes
Other Study ID Numbers: 191622-066
Study First Received: September 12, 2005
Last Updated: May 27, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Botulinum Toxins, Type A
 Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013