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

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.
ClinicalTrials.gov Identifier: NCT01325090
Recruitment Status : Withdrawn
First Posted : March 29, 2011
Last Update Posted : August 22, 2016
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Pain Due to Certain Specified Procedures Neuropathic Pain Drug: BOTOX Other: PLACEBO Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : May 2011
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: BOTOX
Patients will receive in one session multiple intradermal injections of Botox, in order to cover the whole painful area
Drug: BOTOX
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
Other: PLACEBO
The pharmacist will fill syringes in tuberculins of 1 ml with injectable solution of sodium chloride of 0,9 %.


Outcome Measures

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

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

Eligibility Criteria

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
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT01325090


Sponsors and Collaborators
University Hospital, Limoges
Investigators
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
ClinicalTrials.gov Identifier: NCT01325090     History of Changes
Other Study ID Numbers: I09006 / APTODON
2010-021506-38 ( EudraCT Number )
First Posted: March 29, 2011    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: March 2011

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

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
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