Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects (MYSTICOL)
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| ClinicalTrials.gov Identifier: NCT01994109 |
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Recruitment Status :
Completed
First Posted : November 25, 2013
Results First Posted : August 15, 2019
Last Update Posted : July 13, 2021
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Sponsor:
Supernus Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Sialorrhea |
| Interventions |
Drug: MYOBLOC Other: PLACEBO |
| Enrollment | 187 |
Participant Flow
| Recruitment Details | The study was conducted at 33 sites including United States, Russia and Ukraine. |
| Pre-assignment Details | DB: Double Blind (Part A) OL: Open Label (Part B) |
| Arm/Group Title | DB: MYOBLOC 2500 U | DB: MYOBLOC 3500 U | DB: Placebo | OL: ALL MYOBLOC |
|---|---|---|---|---|
 Arm/Group Description |
Participants will receive specified dose of MYOBLOC | Participants will receive specified dose of MYOBLOC | Participants will receive volume matched Placebo | All Participants were to receive 3500 U MYOBLOC but could receive lower doses at investigator discretion. |
| Period Title: Double-blind Phase (Part A) | ||||
| Started | 63 | 64 | 60 | 0 |
| Completed | 62 | 61 | 53 | 0 |
| Not Completed | 1 | 3 | 7 | 0 |
| Period Title: Open-label Phase (Part B) | ||||
| Started | 0 | 0 | 0 [1] | 170 [2] |
| Completed | 0 | 0 | 0 [1] | 128 |
| Not Completed | 0 | 0 | 0 | 42 |
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[1]
No placebo group in Part B.
[2]
61 from 2500 U group, 57 from 3500 U group, 52 from Placebo group continued to Part B
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Baseline Characteristics
| Arm/Group Title | MYOBLOC 2500 U | MYOBLOC 3500 U | PLACEBO | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
Subjects were dosed per treatment assignment of 2500 U MYOBLOC. | Subjects were dosed per treatment assignment of 3500 U MYOBLOC. | Placebo was dosed as an exact match of MYOBLOC. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 63 | 64 | 57 | 184 | |
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Baseline Analysis Population Description |
Demographic Characteristics of intent-to-treat (ITT) Population.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 63 participants | 64 participants | 57 participants | 184 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
29 46.0%
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25 39.1%
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24 42.1%
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78 42.4%
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| >=65 years |
34 54.0%
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39 60.9%
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33 57.9%
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106 57.6%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 63 participants | 64 participants | 57 participants | 184 participants | |
| 62.6 (13.0) | 64.6 (14.0) | 64.1 (13.1) | 63.8 (13.4) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 63 participants | 64 participants | 57 participants | 184 participants | |
| Female |
15 23.8%
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9 14.1%
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16 28.1%
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40 21.7%
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| Male |
48 76.2%
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55 85.9%
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41 71.9%
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144 78.3%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 63 participants | 64 participants | 57 participants | 184 participants | |
| Hispanic or Latino |
5 7.9%
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2 3.1%
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1 1.8%
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8 4.3%
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| Not Hispanic or Latino |
58 92.1%
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62 96.9%
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56 98.2%
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176 95.7%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 63 participants | 64 participants | 57 participants | 184 participants | |
| American Indian or Alaska Native |
0 0.0%
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1 1.6%
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0 0.0%
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1 0.5%
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| Asian |
1 1.6%
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0 0.0%
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1 1.8%
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2 1.1%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
2 3.2%
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1 1.6%
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1 1.8%
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4 2.2%
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| White |
60 95.2%
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60 93.8%
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55 96.5%
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175 95.1%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
0 0.0%
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2 3.1%
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0 0.0%
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2 1.1%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor has the first right, within 9 months following the later to occur 1) close out meeting or 2) Sponsor possessing all data, to publish the lead paper. Following the foregoing, Institution has the right to publish the results provided the Institution provides a Publications Committee, which includes the Sponsor, with a draft at least 30 days before submission. At Sponsor's request, Institution shall withhold publication for 45 days to allow filing of a patent application.
Results Point of Contact
| Name/Title: | Regulatory Affairs Associate |
| Organization: | Solstice Neurosciences |
| EMail: | regulatoryaffairs@usworldmeds.com |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Supernus Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01994109 |
| Other Study ID Numbers: |
SN-SIAL-301 |
| First Submitted: | November 14, 2013 |
| First Posted: | November 25, 2013 |
| Results First Submitted: | May 2, 2019 |
| Results First Posted: | August 15, 2019 |
| Last Update Posted: | July 13, 2021 |