Phase 2
N=18
Dysport for the Treatment of OMD
Oral Dystonia · Tardive Dystonia
Bottom Line
View on ClinicalTrials.gov: NCT01921270 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Mean Global Dystonia Rating Scale Score as Measured by Blinded Rater — 3.80; 3.57; 3.71 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Low Dose - AbobotulinumtoxinA (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Global Dystonia Rating Scale Score as Measured by Blinded Rater |
3.80; 3.57; 3.71 | — |
| SECONDARY Change in Analogue Pain Scale Score |
— | — |
| SECONDARY Mean Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD) Score |
3.00; 2.72; 2.53 | — |
| SECONDARY Change in Number of Tongue Bites Per Day |
— | — |
| SECONDARY Mean Swallowing Disturbance Questionnaire (SDQ-20) Score |
13.17; 15.61; 13.29 | — |
| SECONDARY Mean Fahn-Marsden Part B "Speech" Question (BFM-q21) Rating |
1.33; .94; .94 | — |
| SECONDARY Mean Oromandibular Dystonia Quality of Life Questionnaire (OMDQ-25) Score |
47.39; 43.22; 38.00 | — |
| SECONDARY Mean Global Clinical Impression - Improvement Scale (CGI) Index Score |
2.89; 2.53 | — |
| SECONDARY Mean Global Clinical Impression Scale (CGI-S) With Severity Index Score |
4.06; 3.22; 3.29 | — |
| SECONDARY Mean Global Clinical Impression- Efficacy Index Score |
1.51; 1.93 | — |
| SECONDARY Mean Unified Dystonia Rating Scale (UDRS) Score as Measured by Un-blinded Rater |
4.67; 3.47; 3.26 | — |
| SECONDARY Mean Global Dystonia Rating Scale Score as Measured by Un-blinded Rater |
5.67; 3.94; 3.76 | — |
| SECONDARY Mean Unified Dystonia Rating Scale (UDRS) Score as Measured by Blinded Rater |
3.50; 3.47; 3.30 | — |
Summary
The purpose of this study is to study the efficacy and safety of AbobotulinumtoxinA (Dysport) for use in Oromandibular Dystonia (OMD).
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
Data sourced from ClinicalTrials.gov (NCT01921270). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.