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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
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dysport Injections
Hide Arm/Group Description

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

Period Title: Overall Study
Started 18
Completed 17
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Dysport Injections
Hide Arm/Group Description

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

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
Participants who received low dose Dysport injections.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
62.83  (10.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
12
  66.7%
Male
6
  33.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
 100.0%
1.Primary Outcome
Title Mean Global Dystonia Rating Scale Score as Measured by Blinded Rater
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.
Arm/Group Title Dysport Injections
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 18 participants
3.80  (2.29)
Week 6 Number Analyzed 18 participants
3.57  (2.05)
Week 12 Number Analyzed 17 participants
3.71  (2.18)
2.Secondary Outcome
Title Change in Analogue Pain Scale Score
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were not collected.
Arm/Group Title Dysport Injections
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Mean Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD) Score
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.
Arm/Group Title Dysport Injections
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 18 participants
3.00  (3.91)
Week 6 Number Analyzed 18 participants
2.72  (4.28)
Week 12 Number Analyzed 17 participants
2.53  (3.20)
4.Secondary Outcome
Title Change in Number of Tongue Bites Per Day
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were not collected.
Arm/Group Title Dysport Injections
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Mean Swallowing Disturbance Questionnaire (SDQ-20) Score
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.
Arm/Group Title Dysport Injections
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 18 participants
13.17  (9.51)
Week 6 Number Analyzed 18 participants
15.61  (8.56)
Week 12 Number Analyzed 17 participants
13.29  (8.54)
6.Secondary Outcome
Title Mean Fahn-Marsden Part B "Speech" Question (BFM-q21) Rating
Hide Description The Fahn-Marsden Part B "Speech" Question assesses the ease of producing speech. Responses range from 0=Normal, 1=Slightly involved, easily understood, 2=Some difficulty understanding, 3=Marked difficulty understanding.
Time Frame Baseline, Week 6, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.
Arm/Group Title Dysport Injections
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 18 participants
1.33  (.91)
Week 6 Number Analyzed 18 participants
.94  (.87)
Week 12 Number Analyzed 17 participants
.94  (.75)
7.Secondary Outcome
Title Mean Oromandibular Dystonia Quality of Life Questionnaire (OMDQ-25) Score
Hide Description The OMDQ-25 is a subjective quality of life measurement made for patients with Oromandibular Dystonia. The maximum total score is 100 indicating the highest quality of life. A score of 50 indicates a mediocre quality of life. A lower score indicates perceived lower quality of life.
Time Frame Baseline, Week 6, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.
Arm/Group Title Dysport Injections
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 18 participants
47.39  (23.00)
Week 6 Number Analyzed 18 participants
43.22  (23.24)
Week 12 Number Analyzed 17 participants
38.00  (21.42)
8.Secondary Outcome
Title Mean Global Clinical Impression - Improvement Scale (CGI) Index Score
Hide Description 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".
Time Frame Week 6, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.
Arm/Group Title Dysport Injections
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 6 Number Analyzed 18 participants
2.89  (1.28)
Week 12 Number Analyzed 17 participants
2.53  (.87)
9.Secondary Outcome
Title Mean Global Clinical Impression Scale (CGI-S) With Severity Index Score
Hide Description 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".
Time Frame Baseline, Week 6, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.
Arm/Group Title Dysport Injections
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline Number Analyzed 18 participants
4.06  (1.00)
Week 6 Number Analyzed 18 participants
3.22  (1.11)
Week 12 Number Analyzed 17 participants
3.29  (.92)
10.Secondary Outcome
Title Mean Global Clinical Impression- Efficacy Index Score
Hide Description 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.
Time Frame Week 6, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.
Arm/Group Title Dysport Injections
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 6 Number Analyzed 18 participants
1.51  (.93)
Week 12 Number Analyzed 17 participants
1.93  (.97)
11.Secondary Outcome
Title Mean Unified Dystonia Rating Scale (UDRS) Score as Measured by Un-blinded Rater
Hide Description The UDRS measures dystonia severity. The UDRS is being rated by un-blinded video evaluators regarding severity of subject's dystonia. Scores range from 0 to 10; 0 indicating no dystonia, 5 indicating moderate dystonia, and 10 indicating the worst dystonia.
Time Frame Baseline, Week 6, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.
Arm/Group Title Dysport Injections
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 18 participants
4.67  (1.15)
Week 6 Number Analyzed 18 participants
3.47  (1.58)
Week 12 Number Analyzed 17 participants
3.26  (1.47)
12.Secondary Outcome
Title Mean Global Dystonia Rating Scale Score as Measured by Un-blinded Rater
Hide Description

This scale measures the severity of dystonia for the jaw and tongue by an un-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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.
Arm/Group Title Dysport Injections
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 18 participants
5.67  (1.53)
Week 6 Number Analyzed 18 participants
3.94  (2.10)
Week 12 Number Analyzed 17 participants
3.76  (2.25)
13.Secondary Outcome
Title Mean Unified Dystonia Rating Scale (UDRS) Score as Measured by Blinded Rater
Hide Description The UDRS measures dystonia severity. The UDRS is being rated by blinded video evaluators regarding severity of subject's dystonia. Scores range from 0 to 10; 0 indicating no dystonia, 5 indicating moderate dystonia, and 10 indicating the worst dystonia.
Time Frame Baseline, Week 6, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.
Arm/Group Title Dysport Injections
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 18 participants
3.50  (1.92)
Week 6 Number Analyzed 18 participants
3.47  (1.79)
Week 12 Number Analyzed 17 participants
3.30  (1.72)
Time Frame Adverse events were collected throughout the duration of the study (4 years).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dysport Injections
Hide Arm/Group Description

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

All-Cause Mortality
Dysport Injections
Affected / at Risk (%)
Total   0/18 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Dysport Injections
Affected / at Risk (%) # Events
Total   0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dysport Injections
Affected / at Risk (%) # Events
Total   9/18 (50.00%)    
Gastrointestinal disorders   
Dysphagia   6/18 (33.33%)  6
Throat Tightness/Congestion   3/18 (16.67%)  3
General disorders   
Flu-like Symptoms   2/18 (11.11%)  2
Investigations   
Weight Loss   2/18 (11.11%)  2
Metabolism and nutrition disorders   
Xerostomia   4/18 (22.22%)  4
Drooling   3/18 (16.67%)  3
Difficulty Chewing   2/18 (11.11%)  2
Food Falling Out of Mouth   2/18 (11.11%)  2
Nervous system disorders   
Change in Speech   5/18 (27.78%)  5
Soft Palate Weakness   4/18 (22.22%)  4
Headache   2/18 (11.11%)  2
Respiratory, thoracic and mediastinal disorders   
Coughing   2/18 (11.11%)  2
Indicates events were collected by systematic assessment
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.
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
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