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Early Administration of Botox® in Neuropathic Pain Due to Thoracoscopy or Thoracotomy (APTODON)

This study has been withdrawn prior to enrollment.
Information provided by:
University Hospital, Limoges Identifier:
First received: March 28, 2011
Last updated: August 19, 2016
Last verified: March 2011
Botulinum toxin type A has been reported to inhibit the release of various pain neurotransmitters (SP, CGRP, glutamate) responsible for neurogenic inflammation, a process that results from the sensitization of C-fiber nociceptors (peripheral sensitization). This action is probably responsible for the analgesic effect of botulinum toxin type A recently demonstrated in patients with neuropathic pain of peripheral origin.In those studies, patients had been suffering for years. The investigators can hypothesizes that earlier administration of Botox in the course of neuropathic pain might prevent central sensitization, that is secondary to peripheral sensitization. The investigators can hope to increase efficacy of Botulinum toxin type A injections and to prevent chronification of pain.

Condition Intervention Phase
Pain Due to Certain Specified Procedures Neuropathic Pain Drug: BOTOX Other: PLACEBO Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Early Administration of Botulinum Toxin Type A (Botox®) in Neuropathic Pain Due to Thoracoscopy or Thoracotomy: a Randomized, Double Blind, Placebo Controlled Study

Resource links provided by NLM:

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • decrease in average pain intensity as measured by the Brief Pain Inventory (BPI) [ Time Frame: one month ]

Secondary Outcome Measures:
  • VAS in the last 24 hours [ Time Frame: 24 hours ]
  • Neuropathic Pain Inventory [ Time Frame: 6 months ]

Enrollment: 0
Study Start Date: May 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BOTOX
Patients will receive in one session multiple intradermal injections of Botox, in order to cover the whole painful area
A syringe of 1 ml contain 25 Allergan units.
Placebo Comparator: PLACEBO
Patients will receive in one session multiple intradermal injections of placebo , in order to cover the whole painful area
The pharmacist will fill syringes in tuberculins of 1 ml with injectable solution of sodium chloride of 0,9 %.


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

Inclusion Criteria:

  • daily pain, for 3 months, secondary to thoracoscopy or thoracotomy, of neuropathic origin (DN4 questionary)

Exclusion Criteria:

  • contraindications for botulinum toxin
  Contacts and Locations
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Please refer to this study by its identifier: NCT01325090

Sponsors and Collaborators
University Hospital, Limoges
Principal Investigator: Danièle RANOUX, MD University Hospital, Limoges
  More Information

Responsible Party: Marie SENGELEN / Directrice de la Recherche et de l'Innovation, CHU de Limoges Identifier: NCT01325090     History of Changes
Other Study ID Numbers: I09006 / APTODON
2010-021506-38 ( EudraCT Number )
Study First Received: March 28, 2011
Last Updated: August 19, 2016

Keywords provided by University Hospital, Limoges:
neuropathic pain due to thoracotomy
Neuropathic Pain Due to Thoracoscopy

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
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 processed this record on September 21, 2017