NCT03363113

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
Last Updated

December 6, 2017

Status Verified

November 1, 2017

Enrollment Period

3 months

First QC Date

November 30, 2017

Last Update Submit

November 30, 2017

Conditions

Dystonia; Orofacial

Outcome Measures

Primary Outcomes (1)

  • Clinical improvement score

    Likert scale for the assessment of the clinical improvement after treatment

    Two months

Interventions

Botulinum ToxinsDRUG

Injection of botulinum toxin in the muscles affected by oromandibular dystonia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patient cannot assess symptoms improvement using a Likert scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dystonia

Interventions

Botulinum Toxins

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 6, 2017

Study Start

January 1, 2016

Primary Completion

April 1, 2016

Study Completion

July 12, 2016

Last Updated

December 6, 2017

Record last verified: 2017-11