Dysport for the Treatment of OMD

Brief Title

Dysport for the Treatment of OMD

Official Title

A Pilot Dose Ranging Study of Dysport® (AbobotulinumtoxinA) in the Treatment of Oromandibular Dystonia

Brief Summary

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

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
      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 Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

Mean Global Dystonia Rating Scale Score as Measured by Blinded Rater

Secondary Outcome

 Change in Analogue Pain Scale Score

Condition

Oral Dystonia

Intervention

Low Dose - AbobotulinumtoxinA

Study Arms / Comparison Groups

 Dysport Injections

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

18

Start Date

August 2013

Completion Date

February 8, 2017

Primary Completion Date

February 8, 2017

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Stewart A Factor, DO, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT01921270

Organization ID

IRB00064292

Responsible Party

Principal Investigator

Study Sponsor

Emory University

Collaborators

 Ipsen

Study Sponsor

Stewart A Factor, DO, Principal Investigator, Emory University

Verification Date

October 2017