Dysport for the Treatment of OMD

Phase 2CompletedNCT01921270

Emory University18 enrolled

Overview

The purpose of this study is to study the efficacy and safety of AbobotulinumtoxinA (Dysport) for use in Oromandibular Dystonia (OMD).

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Oral Dystonia Tardive Dystonia

Interventions

Low Dose - AbobotulinumtoxinADRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Wesley Woods Health Center; Emory University Hospital

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Mean Global Dystonia Rating Scale Score as Measured by Blinded Rater

This scale measures the severity of dystonia for the jaw and tongue by a blinded rater. Dystonia is rated from 0 to 10: 0=No dystonia present, 1=Minimal dystonia, 5=Moderate dystonia,10=Most severe dystonia

Time frame: Baseline, Week 6, Week 12

Secondary Outcomes

Change in Analogue Pain Scale Score

Measure of jaw pain by visual analogue scale (0-100) where 0 represents "no pain" and 100 represents the "most severe pain".

Time frame: Baseline, Week 12

Mean Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD) Score

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. A higher score indicates greater drooling severity. A lower score indicates lesser severity.

Time frame: Baseline, Week 6, Week 12

Change in Number of Tongue Bites Per Day

The patient will be asked to estimate how many times they tend to accidentally/involuntarily bite their tongue per day.

Time frame: Baseline, Week 12

Mean Swallowing Disturbance Questionnaire (SDQ-20) Score

Ease of chewing and swallowing will be assessed by the SDQ-20 (modified to exclude question 5 due to redundancy as it relates to drooling and question 15 which is not relevant to the study as it involves prior aspiration pneumonias). 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; a lower score indicating no or less frequent disturbance, with a possible maximum score of 39.

Time frame: Baseline, Week 6, Week 12

Data from ClinicalTrials.gov

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