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
  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:


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
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.

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

ClinicalTrials.gov processed this record on October 30, 2014