Dysport for the Treatment of OMD

NCT01921270 | Completed Phase 1 Results

• 1 other identifier: IRB00064292
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oral Dystonia; Tardive Dystonia

Keywords

Oromandibular Dystonia; Oral Dystonia; Tardive Dystonia; botulinum toxin; abobotulinumtoxinA

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, Week 6, Week 12

Secondary Outcomes (12)

• Change in Analogue Pain Scale Score

  Baseline, Week 12

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

  Baseline, Week 6, Week 12

• Change in Number of Tongue Bites Per Day

  Baseline, Week 12

• Mean Swallowing Disturbance Questionnaire (SDQ-20) Score

  Baseline, Week 6, Week 12

• Mean Fahn-Marsden Part B "Speech" Question (BFM-q21) Rating

  Baseline, Week 6, Week 12

Study Arms (1)

Dysport Injections

EXPERIMENTAL

Participants with OMD who have been previously treated with any botulinum toxin Type A will be injected with Dysport®.

Drug: Low Dose - AbobotulinumtoxinA

Interventions

Low Dose - AbobotulinumtoxinA DRUG

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

Also known as: Dysport

Dysport Injections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Ipsen: collaborator

Study Sites (1)

Wesley Woods Health Center; Emory University Hospital

Atlanta, Georgia, 30329, United States

Location

Related Publications (2)

• 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.

  PMID: 10599789 BACKGROUND

• 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.

  PMID: 21348790 BACKGROUND

MeSH Terms

Conditions

Tardive Dyskinesia

Interventions

abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Dyskinesia, Drug-Induced; Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The phase 1 study preceding this trial was intended to assess three different Dysport doses. Two participants developed adverse events at the lowest dose in the phase 1 study. Therefore, the lowest dosage level was used for all phase 2 participants.

Results Point of Contact

• Title: Dr. Stewart Factor
• Organization: Emory University

sfactor@emory.edu

404-728-4952

Study Officials

• Stewart A Factor, DO

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: August 13, 2013
• Study Start: August 1, 2013
• Primary Completion: February 8, 2017
• Study Completion: February 8, 2017
• Last Updated: November 17, 2017
• Results First Posted: November 17, 2017

Record last verified: 2017-10

Locations

US (1)