Efficacy Study of Botox to Treat Neuropathic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00527202
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : September 10, 2007
Information provided by:
Hospital Ambroise Paré Paris

Brief Summary:
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 or disease Intervention/treatment Phase
Postherpetic Neuralgia Nerve Trauma Drug: botulinum toxin A and saline Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2004
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: 1
active treatment arm
Drug: botulinum toxin A and saline
Placebo Comparator: 2 Drug: botulinum toxin A and saline

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00527202

Hôpital Ambroise Paré, AP-HP
Boulogne-billancourt, France, 92100f
Sponsors and Collaborators
Hospital Ambroise Paré Paris
Study Director: Didier BOUHASSIRA, MD, PHD INSERM U 792
Study Chair: Danièle RANOUX, MD hôpital de Limoges (FRANCE) Identifier: NCT00527202     History of Changes
Other Study ID Numbers: BTXneurop-1
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: September 10, 2007
Last Verified: September 2007

Additional relevant MeSH terms:
Neuralgia, Postherpetic
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents