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Outcome of Botulinum Toxin Treatment for Oromandibular Dystonia (rétroBODOM)

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: NCT03363113
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:
Symptoms of oromandibular dystonia can be alleviated by injections of botulinum toxin. The scope of this study is to describe the efficacy of this procedure, by a retrospective systematic review of patients medical charts

Condition or disease Intervention/treatment
Dystonia; Orofacial Drug: Botulinum Toxins

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Study Type : Observational
Actual Enrollment : 240 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Outcome of Botulinum Toxin Treatment for Oromandibular Dystonia
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : April 1, 2016
Actual Study Completion Date : July 12, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

Intervention Details:
  • Drug: Botulinum Toxins
    Injection of botulinum toxin in the muscles affected by oromandibular dystonia

Primary Outcome Measures :
  1. Clinical improvement score [ Time Frame: Two months ]
    Likert scale for the assessment of the clinical improvement after treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated by botulinum toxin injection for oromandibular dystonia in the Fondation Rothschild (Paris)

Inclusion Criteria:

  • Patient suffering from oromandibular dystonia
  • Medical follow up in the Fondation Ophtalmologique Rothschild (Paris)
  • Treatment by at least one session of botulinum toxin injection

Exclusion Criteria:

  • Patient cannot assess symptoms improvement using a Likert scale
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild Identifier: NCT03363113    
Other Study ID Numbers: CE_20150630_7_LSM
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dystonic Disorders
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs