Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
18 participants
INTERVENTIONAL
2013-08-31
2017-02-08
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dysport Injections
Participants with OMD who have been previously treated with any botulinum toxin Type A will be injected with Dysport®.
Low Dose - AbobotulinumtoxinA
Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.
Muscles that may be included for in injection for OMD with Jaw Closing:
Medial Pterygoid 50 units, Masseter 25 units
Muscles that may be included in injection for OMD with Jaw Opening:
Lateral Pterygoid 50 units, Anterior digastrics 10 units
Muscle that will be included in injection for OMD with Tongue Protrusion:
Genioglossus 7.5 units
Interventions
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Low Dose - AbobotulinumtoxinA
Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.
Muscles that may be included for in injection for OMD with Jaw Closing:
Medial Pterygoid 50 units, Masseter 25 units
Muscles that may be included in injection for OMD with Jaw Opening:
Lateral Pterygoid 50 units, Anterior digastrics 10 units
Muscle that will be included in injection for OMD with Tongue Protrusion:
Genioglossus 7.5 units
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Emory University
OTHER
Responsible Party
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Stewart Factor
Professor
Principal Investigators
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Stewart A Factor, DO
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Wesley Woods Health Center; Emory University Hospital
Atlanta, Georgia, United States
Countries
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References
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Tan EK, Jankovic J. Botulinum toxin A in patients with oromandibular dystonia: long-term follow-up. Neurology. 1999 Dec 10;53(9):2102-7. doi: 10.1212/wnl.53.9.2102.
Rosales RL, Ng AR, Santos MM, Fernandez HH. The broadening application of chemodenervation in X-linked dystonia-parkinsonism (Part II): an open-label experience with botulinum toxin-A (Dysport(R)) injections for oromandibular, lingual, and truncal-axial dystonias. Int J Neurosci. 2011;121 Suppl 1:44-56. doi: 10.3109/00207454.2011.558260.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB00064292
Identifier Type: -
Identifier Source: org_study_id