Outcome of Botulinum Toxin Treatment for Oromandibular Dystonia (rétroBODOM)

November 30, 2017 updated by: Fondation Ophtalmologique Adolphe de Rothschild
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated by botulinum toxin injection for oromandibular dystonia in the Fondation Rothschild (Paris)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical improvement score
Time Frame: Two months
Likert scale for the assessment of the clinical improvement after treatment
Two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

July 12, 2016

Study Registration Dates

First Submitted

November 30, 2017

First Submitted That Met QC Criteria

November 30, 2017

First Posted (Actual)

December 6, 2017

Study Record Updates

Last Update Posted (Actual)

December 6, 2017

Last Update Submitted That Met QC Criteria

November 30, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE_20150630_7_LSM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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