Trial · NCT01921270
Dysport for the Treatment of OMD
NCT01921270, Phase 1, Phase 2, Completed, Emory University; results first posted 2017-11-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dysport for the Treatment of OMD. Trials, record NCT01921270. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01921270
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dysport for the Treatment of OMD
- NCT number
- NCT01921270
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Oral Dystonia, Tardive Dystonia
- Interventions
- Low Dose - AbobotulinumtoxinA
- First posted
- 2013-08-13
- Last updated
- 2017-11-17
- Results first posted
- 2017-11-17
- 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.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Global Dystonia Rating Scale Score as Measured by Blinded Rater | Baseline, Week 6, Week 12 | 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 |
| Secondary | Change in Analogue Pain Scale Score | 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". |
| Secondary | Mean Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD) Score | Baseline, Week 6, 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. A higher score indicates greater drooling severity. A lower score indicates lesser severity. |
| Secondary | Change in Number of Tongue Bites Per Day | Baseline, Week 12 | The patient will be asked to estimate how many times they tend to accidentally/involuntarily bite their tongue per day. |
| Secondary | Mean Swallowing Disturbance Questionnaire (SDQ-20) Score | Baseline, Week 6, Week 12 | 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. |
| Secondary | Mean Fahn-Marsden Part B "Speech" Question (BFM-q21) Rating | Baseline, Week 6, Week 12 | 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. |
| Secondary | Mean Oromandibular Dystonia Quality of Life Questionnaire (OMDQ-25) Score | Baseline, Week 6, 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 the highest quality of life. A score of 50 indicates a mediocre quality of life. A lower score indicates perceived lower quality of life. |
| Secondary | Mean Global Clinical Impression - Improvement Scale (CGI) Index Score | Week 6, Week 12 | 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". |
| Secondary | Mean Global Clinical Impression Scale (CGI-S) With Severity Index Score | Baseline, Week 6, Week 12 | 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". |
| Secondary | Mean Global Clinical Impression- Efficacy Index Score | Week 6, Week 12 | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Global Dystonia Rating Scale Score as Measured by Blinded Rater | Baseline, Week 6, Week 12 | 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. | units on a scale | MEAN |
| SECONDARY | Change in Analogue Pain Scale Score | Baseline, Week 12 | Data were not collected. | ||
| SECONDARY | Mean Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD) Score | Baseline, Week 6, Week 12 | 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. | units on a scale | MEAN |
| SECONDARY | Change in Number of Tongue Bites Per Day | Baseline, Week 12 | Data were not collected. | ||
| SECONDARY | Mean Swallowing Disturbance Questionnaire (SDQ-20) Score | Baseline, Week 6, Week 12 | 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. | units on a scale | MEAN |
| SECONDARY | Mean Fahn-Marsden Part B Speech Question (BFM-q21) Rating | Baseline, Week 6, Week 12 | 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. | units on a scale | MEAN |
| SECONDARY | Mean Oromandibular Dystonia Quality of Life Questionnaire (OMDQ-25) Score | Baseline, Week 6, Week 12 | 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. | units on a scale | MEAN |
| SECONDARY | Mean Global Clinical Impression - Improvement Scale (CGI) Index Score | Week 6, Week 12 | 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. | units on a scale | MEAN |
| SECONDARY | Mean Global Clinical Impression Scale (CGI-S) With Severity Index Score | Baseline, Week 6, Week 12 | 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. | units on a scale | MEAN |
| SECONDARY | Mean Global Clinical Impression- Efficacy Index Score | Week 6, Week 12 | 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. | units on a scale | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Global Dystonia Rating Scale Score as Measured by Blinded Rater | Dysport Injections | Baseline | 3.80 | Standard Deviation 2.29 | units on a scale |
| Mean Global Dystonia Rating Scale Score as Measured by Blinded Rater | Dysport Injections | Week 6 | 3.57 | Standard Deviation 2.05 | units on a scale |
| Mean Global Dystonia Rating Scale Score as Measured by Blinded Rater | Dysport Injections | Week 12 | 3.71 | Standard Deviation 2.18 | units on a scale |
| Mean Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD) Score | Dysport Injections | Baseline | 3.00 | Standard Deviation 3.91 | units on a scale |
| Mean Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD) Score | Dysport Injections | Week 6 | 2.72 | Standard Deviation 4.28 | units on a scale |
| Mean Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD) Score | Dysport Injections | Week 12 | 2.53 | Standard Deviation 3.20 | units on a scale |
| Mean Swallowing Disturbance Questionnaire (SDQ-20) Score | Dysport Injections | Baseline | 13.17 | Standard Deviation 9.51 | units on a scale |
| Mean Swallowing Disturbance Questionnaire (SDQ-20) Score | Dysport Injections | Week 6 | 15.61 | Standard Deviation 8.56 | units on a scale |
| Mean Swallowing Disturbance Questionnaire (SDQ-20) Score | Dysport Injections | Week 12 | 13.29 | Standard Deviation 8.54 | units on a scale |
| Mean Fahn-Marsden Part B Speech Question (BFM-q21) Rating | Dysport Injections | Baseline | 1.33 | Standard Deviation .91 | units on a scale |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dysport Injections | 18 | |
| Overall Study | COMPLETED | Dysport Injections | 17 | |
| Overall Study | NOT COMPLETED | Dysport Injections | 1 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dysphagia | Gastrointestinal disorders | Dysport Injections | 6 | 18 | 6 |
| other | Change in Speech | Nervous system disorders | Dysport Injections | 5 | 18 | 5 |
| other | Soft Palate Weakness | Nervous system disorders | Dysport Injections | 4 | 18 | 4 |
| other | Xerostomia | Metabolism and nutrition disorders | Dysport Injections | 4 | 18 | 4 |
| other | Throat Tightness/Congestion | Gastrointestinal disorders | Dysport Injections | 3 | 18 | 3 |
| other | Drooling | Metabolism and nutrition disorders | Dysport Injections | 3 | 18 | 3 |
| other | Difficulty Chewing | Metabolism and nutrition disorders | Dysport Injections | 2 | 18 | 2 |
| other | Food Falling Out of Mouth | Metabolism and nutrition disorders | Dysport Injections | 2 | 18 | 2 |
| other | Coughing | Respiratory, thoracic and mediastinal disorders | Dysport Injections | 2 | 18 | 2 |
| other | Weight Loss | Investigations | Dysport Injections | 2 | 18 | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dysport Injections | 0 | 18 |
| Total, other adverse events | Dysport Injections | 9 | 18 |
| Total, serious adverse events | Dysport Injections | 0 | 18 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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