Efficacy Study of Botox to Treat Neuropathic Pain

This study has been completed.
Sponsor:
Information provided by:
Hôpital Européen Marseille
ClinicalTrials.gov Identifier:
NCT00527202
First received: September 7, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  Purpose

Objectives : to investigate the analgesic effects and safety of intradermal botulinum toxin A injection in the treatment of focal painful neuropathies (eg, postherpetic neuralgia, nerve trauma)


Condition Intervention Phase
Postherpetic Neuralgia
Nerve Trauma
Drug: botulinum toxin A and saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Placebo-Controlled Study of the Efficacy of Botulinum Toxin Type A (Botox) in Spontaneous Pain and Allodynia Related to Traumatic Nerve Injury or Postherpetic Neuralgia

Resource links provided by NLM:


Further study details as provided by Hôpital Européen Marseille:

Primary Outcome Measures:
  • Self-reported pain (numerical scales) on patients diaries [ Time Frame: prospective ]

Secondary Outcome Measures:
  • mean pain (VAS) at each visit Quality of life Proportion of responders % pain relief Clinical global impression Assessment of blindedness [ Time Frame: prospective ]

Enrollment: 29
Study Start Date: June 2004
Study Completion Date: March 2007
Arms Assigned Interventions
Experimental: 1
active treatment arm
Drug: botulinum toxin A and saline
Placebo Comparator: 2 Drug: botulinum toxin A and saline

Detailed Description:

The study will be randomized, performed in parallel group and double blind versus saline and will include 30 patients. Botulinum toxin injection will be injected intradermally in the painful area (one single injection) following a method adapted from that used in hyperhidrosis. The patients will be followed for 6 months after the injection. Primary outcome will be self-reported pain from the patients diaries. Secondary outcomes will be neuropathic symptoms, quality of life, allodynia to brush and pressure, detection and pain thresholds, proportion of responders, pain relief and clinical global impression. Clinical assessment will take place before injection then at 1 month, 3 months and 6 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • daily pain for at least 6 months of at least moderate intensity clearly attributed to the nerve lesion
  • limited area of pain
  • mechanical allodynia in the painful area

Exclusion Criteria:

  • contraindication to BTXA formulation
  • coagulation disorders
  • another painful condition
  • current major depression
  • history of drug or alcohol abuse
  • compensation claim or litigation
  • facial neuropathic pain
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527202

Locations
France
Hôpital Ambroise Paré, AP-HP
Boulogne-billancourt, France, 92100f
Sponsors and Collaborators
Hôpital Européen Marseille
Investigators
Study Director: Didier BOUHASSIRA, MD, PHD INSERM U 792
Study Chair: Danièle RANOUX, MD hôpital de Limoges (FRANCE)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00527202     History of Changes
Other Study ID Numbers: BTXneurop-1
Study First Received: September 7, 2007
Last Updated: September 7, 2007
Health Authority: France: Direction Générale de la Santé

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 July 24, 2014