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Dysport for the Treatment of OMD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01921270
First Posted: August 13, 2013
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ipsen
Information provided by (Responsible Party):
Stewart Factor, Emory University
  Purpose
The purpose of this study is to study the efficacy and safety of AbobotulinumtoxinA (Dysport) for use in Oromandibular Dystonia (OMD).

Condition Intervention Phase
Oral Dystonia Tardive Dystonia Drug: Low Dose - AbobotulinumtoxinA Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
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

Resource links provided by NLM:


Further study details as provided by Stewart Factor, Emory University:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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.


Enrollment: 21
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)
Arms Assigned Interventions
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

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 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921270


Locations
United States, Georgia
Wesley Woods Health Center; Emory University Hospital
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Emory University
Ipsen
Investigators
Principal Investigator: Stewart A Factor, DO Emory University
  More Information

Publications:
Responsible Party: Stewart Factor, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01921270     History of Changes
Other Study ID Numbers: IRB00064292
First Submitted: August 9, 2013
First Posted: August 13, 2013
Last Update Posted: October 23, 2017
Last Verified: July 2017

Keywords provided by Stewart Factor, Emory University:
Oromandibular Dystonia
Oral Dystonia
Tardive Dystonia
botulinum toxin
abobotulinumtoxinA

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Tardive Dyskinesia
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Dyskinesia, Drug-Induced
Botulinum Toxins
abobotulinumtoxinA
Botulinum Toxins, Type A
onabotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents