Dysport for the Treatment of OMD
Completed · Phase 1/Phase 2
Conditions studied: Oral Dystonia, Tardive Dystonia
In brief
The purpose of this study is to study the efficacy and safety of AbobotulinumtoxinA (Dysport) for use in Oromandibular Dystonia (OMD).
Key facts
- Study ID
- NCT01921270
- Run by
- Emory University
- People needed
- 18
- Starts
- 2013-08-01
- Expected to finish
- 2017-02-08
- Last updated by the study team
- 2017-11-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- a diagnosis of primary or tardive OMD
- moderate or severe severity, defined as GDS score ≥4 in either "lower face" or "jaw and tongue" section
- capability of attending the scheduled visits
- only those who have been previously injected with onabotulinumtoxinA and responded to that treatment, and are at least 12 weeks post last injection
- Women of childbearing age need to use contraception in order to be included.
You may not qualify if…
- Existence of a systemic disease that could confound the evaluation
- previous placement of Deep Brain Stimulation electrodes to treat dystonia
- concomitant oral medications that could interfere with the action of botulinum toxin Type A (e.g., aminoglycosides)
- on an unstable dosage of any medication prescribed to treat dystonia (e.g., benzodiazepines, baclofen or anticholinergics)
- any known hypersensitivity to any botulinum toxin preparation and allergy to cow's milk protein
- immunoresistance to other forms of botulinum toxin type A
- existence of a concomitant neuromuscular disorder (e.g., Myasthenia Gravis or Lambert-Eaton syndrome, etc)
- infection at the proposed injection sites
- pregnant women
- women of childbearing age NOT on contraception
- breastfeeding women
- inability to comply with scheduled visits
- patients who had been previously injected with botulinum toxin type A but who did not respond
Where it is running
- Wesley Woods Health Center; Emory University Hospital — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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