Brief Title
Dysport for the Treatment of OMD
Official Title
A Pilot Dose Ranging Study of Dysport® (AbobotulinumtoxinA) in the Treatment of Oromandibular Dystonia
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 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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Mean Global Dystonia Rating Scale Score as Measured by Blinded Rater
Secondary Outcome
Change in Analogue Pain Scale Score
Condition
Oral Dystonia
Intervention
Low Dose - AbobotulinumtoxinA
Study Arms / Comparison Groups
Dysport Injections
Description: Participants with OMD who have been previously treated with any botulinum toxin Type A will be injected with Dysport®.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
18
Start Date
August 2013
Completion Date
February 8, 2017
Primary Completion Date
February 8, 2017
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Stewart A Factor, DO, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01921270
Organization ID
IRB00064292
Responsible Party
Principal Investigator
Study Sponsor
Emory University
Collaborators
Ipsen
Study Sponsor
Stewart A Factor, DO, Principal Investigator, Emory University
Verification Date
October 2017