Status:
COMPLETED
Dysport for the Treatment of OMD
Lead Sponsor:
Emory University
Collaborating Sponsors:
Ipsen
Conditions:
Oral Dystonia
Tardive Dystonia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to study the efficacy and safety of AbobotulinumtoxinA (Dysport) for use in Oromandibular Dystonia (OMD).
Detailed Description
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 inc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2017
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01921270
Start Date
August 1 2013
End Date
February 8 2017
Last Update
November 17 2017
Active Locations (1)
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1
Wesley Woods Health Center; Emory University Hospital
Atlanta, Georgia, United States, 30329