Dysport for the Treatment of OMD
|Oral Dystonia Tardive Dystonia||Drug: Low Dose - AbobotulinumtoxinA||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Evaluators will review the videotaped examinations, presented in a random order, using the Global Dystonia Rating scale (GDS). The evaluators will rate the dystonia at baseline (injection visit) and 6 weeks after injection.Primary Purpose: Treatment
|Official Title:||A Pilot Dose Ranging Study of Dysport® (AbobotulinumtoxinA) in the Treatment of Oromandibular Dystonia|
- Change in Global Dystonia Rating Scale Score [ Time Frame: Baseline, Week 12 ]
This scale measures the severity of dystonia for a certain body part--in this study it will be "lower face" and "jaw and tongue" sections. Dystonia is rated from 0 to 10:
0=No dystonia present, 1=Minimal dystonia, 5=Moderate dystonia,10=Most severe dystonia
- Change in Analogue Pain Scale Score [ Time Frame: Baseline, Week 12 ]Measure of jaw pain by visual analogue scale (0-100) where 0 represents "no pain" and 100 represents the "most severe pain".
- Change in Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD) Score [ Time Frame: Baseline, Week 12 ]The SCS-PD measures drooling. Individual items are scored on a scale from 0-3 where 0 represents "never" and 3 represents "always". The overall maximum score is 21.
- Change in Number of Tongue Bites per Day [ Time Frame: Baseline, Week 12 ]The patient will be asked to estimate how many times they tend to accidentally/involuntarily bite their tongue per day.
- Change in Swallowing Disturbance Questionnaire (SDQ-20) Score [ Time Frame: Baseline, Week 12 ]Ease of chewing and swallowing will be assessed by the SDQ. Individual items are scored from 0 (never) to 3 (very frequently). The overall score is the total for all items; a higher score indicating more frequent swallowing disturbance.
- Change in Fahn-Marsden Part B "Speech" Question (BFM-q21) Rating [ Time Frame: Baseline, Week 12 ]The Fahn-Marsden Part B "Speech" Question assess the ease of producing speech. Responses range from 0=Normal, 1=Slightly involved, easily understood, 2=Some difficulty understanding, 3=Marked difficulty understanding.
- Change in Oromandibular Dystonia Quality of Life Questionnaire (OMDQ-25) Score [ Time Frame: Baseline, Week 12 ]The OMDQ-25 is a subjective quality of life measurement made for patients with Oromandibular Dystonia. The maximum total score is 100 indicating a very high quality of life.
- Mean Global Clinical Impression - Improvement Scale (CGI) Index Score [ Time Frame: Week 6 ]The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Responses are scored on a scale from 1 to 7; 1 represents "very much improved" and 7 represents "very much worse".
- Mean Global Clinical Impression Scale (CGI-S) with Severity Index Score [ Time Frame: Week 6 ]The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Responses are scored on a scale from 1 to 7; 1 represents "normal, not at all ill" and 7 represents "among the most extremely ill patients".
- Mean Global Clinical Impression- Efficacy Index Score [ Time Frame: Week 6 ]The Clinical Global Impression - Efficacy Index is a 4×4 rating scale that assesses the therapeutic effect of treatment. Responses range on a scale from 0 to 4 with 4 being the best response.
- Change in Unified Dystonia Rating Scale (UDRS) Score [ Time Frame: Baseline, Week 12 ]The UDRS measured dystonia severity. The UDRS is being rated by blinded video evaluators regarding severity of subject's dystonia. The maximum score is 8 referring to the most severe dystonia.
|Study Start Date:||August 2013|
|Study Completion Date:||February 8, 2017|
|Primary Completion Date:||February 8, 2017 (Final data collection date for primary outcome measure)|
Experimental: Dysport Injections
Participants with OMD who have been previously treated with any botulinum toxin Type A will be injected with Dysport®.
Drug: 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 Name: Dysport
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 two 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01921270
|United States, Georgia|
|Wesley Woods Health Center; Emory University Hospital|
|Atlanta, Georgia, United States, 30329|
|Principal Investigator:||Stewart A Factor, DO||Emory University|