Tardive Dystonia Clinical Trial
Official title:
A Pilot Dose Ranging Study of Dysport® (AbobotulinumtoxinA) in the Treatment of Oromandibular Dystonia
The purpose of this study is to study the efficacy and safety of AbobotulinumtoxinA (Dysport) for use in Oromandibular Dystonia (OMD).
Oromandibular dystonia (OMD) is an uncommon, disabling form of cranial dystonia, involving
involuntary movements of the lower facial, masticatory, and lingual muscles. This can cause
jaw movements including opening, closure, protrusion, retraction, or deviation. Common
additional facial movements involve grimacing or lip pursing. When there is tongue
involvement, it usually presents as tongue protrusion or curling. Such patients are impaired
in relation to eating, speaking and swallowing
This study aims to evaluate the efficacy and safety of a low dose of Dysport® deemed
tolerable during phase 1 in subjects with oromandibular dystonia (OMD).
Participants will be injected with Dysport® only, with an unblinded open-label disclosure.
The safety and efficacy pf receiving Dysport® will be recorded for all subjects that undergo
injection. All subjects will be examined and videotaped at the injection visit, then at 6 and
12 weeks after injection with a standardized protocol. The primary outcome will be blinded
examination scores of the videos performed after the study is complete.The evaluators will be
three different movement disorders experts, not otherwise involved in the study, who will
review the videotaped examinations, presented in a random order, using the Global Dystonia
Rating scale (GDS). Evaluators will rate the dystonia at baseline (injection visit) and 6
weeks after injection.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
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| Terminated |
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