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Dysport for the Treatment of OMD

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ClinicalTrials.gov Identifier: NCT01921270
Recruitment Status : Completed
First Posted : August 13, 2013
Results First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
Ipsen
Information provided by (Responsible Party):
Stewart Factor, Emory University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Oral Dystonia
Tardive Dystonia
Intervention: Drug: Low Dose - AbobotulinumtoxinA

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dysport Injections

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

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


Participant Flow:   Overall Study
    Dysport Injections
STARTED   18 
COMPLETED   17 
NOT COMPLETED   1 
Withdrawal by Subject                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received low dose Dysport injections.

Reporting Groups
  Description
Dysport Injections

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

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


Baseline Measures
   Dysport Injections 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed   18 
   62.83  (10.45) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed   18 
Female      12  66.7% 
Male      6  33.3% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   
Participants Analyzed   18 
United States   18 


  Outcome Measures

1.  Primary:   Mean Global Dystonia Rating Scale Score as Measured by Blinded Rater   [ Time Frame: Baseline, Week 6, Week 12 ]

2.  Secondary:   Change in Analogue Pain Scale Score   [ Time Frame: Baseline, Week 12 ]

3.  Secondary:   Mean Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD) Score   [ Time Frame: Baseline, Week 6, Week 12 ]

4.  Secondary:   Change in Number of Tongue Bites Per Day   [ Time Frame: Baseline, Week 12 ]

5.  Secondary:   Mean Swallowing Disturbance Questionnaire (SDQ-20) Score   [ Time Frame: Baseline, Week 6, Week 12 ]

6.  Secondary:   Mean Fahn-Marsden Part B "Speech" Question (BFM-q21) Rating   [ Time Frame: Baseline, Week 6, Week 12 ]

7.  Secondary:   Mean Oromandibular Dystonia Quality of Life Questionnaire (OMDQ-25) Score   [ Time Frame: Baseline, Week 6, Week 12 ]

8.  Secondary:   Mean Global Clinical Impression - Improvement Scale (CGI) Index Score   [ Time Frame: Week 6, Week 12 ]

9.  Secondary:   Mean Global Clinical Impression Scale (CGI-S) With Severity Index Score   [ Time Frame: Baseline, Week 6, Week 12 ]

10.  Secondary:   Mean Global Clinical Impression- Efficacy Index Score   [ Time Frame: Week 6, Week 12 ]

11.  Secondary:   Mean Unified Dystonia Rating Scale (UDRS) Score as Measured by Un-blinded Rater   [ Time Frame: Baseline, Week 6, Week 12 ]

12.  Secondary:   Mean Global Dystonia Rating Scale Score as Measured by Un-blinded Rater   [ Time Frame: Baseline, Week 6, Week 12 ]

13.  Secondary:   Mean Unified Dystonia Rating Scale (UDRS) Score as Measured by Blinded Rater   [ Time Frame: Baseline, Week 6, Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Stewart Factor
Organization: Emory University
phone: 404-728-4952
e-mail: sfactor@emory.edu


Publications:

Responsible Party: Stewart Factor, Emory University
ClinicalTrials.gov Identifier: NCT01921270     History of Changes
Other Study ID Numbers: IRB00064292
First Submitted: August 9, 2013
First Posted: August 13, 2013
Results First Submitted: July 24, 2017
Results First Posted: November 17, 2017
Last Update Posted: November 17, 2017