CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Low Dose - AbobotulinumtoxinAdrug
Likely dose
Low Dose - AbobotulinumtoxinA 50 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01921270
NCT01921270Phase 2Completed
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A Pilot Dose Ranging Study of Dysport® (AbobotulinumtoxinA) in the Treatment of Oromandibular Dystonia

Emory University·interventional·Posted Aug 13, 2013·Updated Nov 17, 2017

In Brief

A Phase 2 clinical trial evaluating Low Dose - AbobotulinumtoxinA for Oral Dystonia and Tardive Dystonia. Completed, enrolled 18 participants across 1 site.

Detailed Summary

The purpose of this study is to study the efficacy and safety of AbobotulinumtoxinA (Dysport) for use in Oromandibular Dystonia (OMD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOral Dystonia, Tardive Dystonia
CountriesUnited States
CollaboratorsIpsen

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 13, 2013
Enrollment StartAug 1, 2013
Primary CompletionFeb 8, 2017
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 12.9 years ago

Interventions

Low Dose - AbobotulinumtoxinAdrug

Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom. Muscles that may be included for in injection for OMD with Jaw Closing: Medial Pterygoid 50 units, Masseter 25 units Muscles that may be included in injection for OMD with Jaw Opening: Lateral Pterygoid 50 units, Anterior digastrics 10 units Muscle that will be included in injection for OMD with Tongue Protrusion: Genioglossus 7.5 units