Dysport for the Treatment of OMD

• Status: Completed
• Trial end date: 2017-02-08
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: Ipsen
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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