Trial Outcomes & Findings for A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients (NCT NCT00515437)
NCT ID: NCT00515437
Last Updated: 2019-05-07
Results Overview
9 point scale, 0 = no drooling, 9 = severe drooling
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
baseline versus 4 weeks post-injection
Results posted on
2019-05-07
Participant Flow
24 centers were initiated to screen and enroll subjects. Enrollment began in July 2007 and completed in March 2008. 54 subjects were enrolled at 17 centers
Participant milestones
| Measure |
1500U Myobloc
1500U Myobloc
|
2500U Myobloc
2500U Myobloc
|
3500U Myobloc
3500U Myobloc
|
Placebo
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
13
|
15
|
|
Overall Study
COMPLETED
|
14
|
12
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients
Baseline characteristics by cohort
| Measure |
1500U Myobloc
n=14 Participants
1500U Myobloc
|
2500U Myobloc
n=12 Participants
2500U Myobloc
|
3500U Myobloc
n=13 Participants
3500U Myobloc
|
Placebo
n=15 Participants
Placebo
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 7 • n=5 Participants
|
71 years
STANDARD_DEVIATION 8 • n=7 Participants
|
74 years
STANDARD_DEVIATION 5 • n=5 Participants
|
71 years
STANDARD_DEVIATION 11 • n=4 Participants
|
71 years
STANDARD_DEVIATION 8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
12 participants
n=7 Participants
|
13 participants
n=5 Participants
|
15 participants
n=4 Participants
|
54 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: baseline versus 4 weeks post-injectionPopulation: Intent to Treat (ITT)
9 point scale, 0 = no drooling, 9 = severe drooling
Outcome measures
| Measure |
1500U Myobloc
n=14 Participants
1500U Myobloc
|
2500U Myobloc
n=12 Participants
2500U Myobloc
|
3500U Myobloc
n=13 Participants
3500U Myobloc
|
Placebo
n=14 Participants
Placebo
|
|---|---|---|---|---|
|
Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection
|
-2.1 points on a scale
Standard Deviation 1.2
|
-3.3 points on a scale
Standard Deviation 1.4
|
-3.5 points on a scale
Standard Deviation 1.0
|
-1.3 points on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: baseline vs 12 weeks post injection9 point scale (0=no drooling, 9=severe drooling)
Outcome measures
| Measure |
1500U Myobloc
n=14 Participants
1500U Myobloc
|
2500U Myobloc
n=12 Participants
2500U Myobloc
|
3500U Myobloc
n=13 Participants
3500U Myobloc
|
Placebo
n=14 Participants
Placebo
|
|---|---|---|---|---|
|
Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection
|
-1.9 points on a scale
Standard Deviation 1.5
|
-2.2 points on a scale
Standard Deviation 1.6
|
-2.2 points on a scale
Standard Deviation 0.8
|
-1.2 points on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: baseline vs 4 weeks post-injectionsaliva is collected over 5 minutes and weighed to produce a grams/minute "rate"
Outcome measures
| Measure |
1500U Myobloc
n=14 Participants
1500U Myobloc
|
2500U Myobloc
n=12 Participants
2500U Myobloc
|
3500U Myobloc
n=13 Participants
3500U Myobloc
|
Placebo
n=14 Participants
Placebo
|
|---|---|---|---|---|
|
Change in Unstimulated Salivary Flow Rate at Wk 4 Post-injection
|
-0.497 grams/minute
Standard Deviation 0.38
|
-.381 grams/minute
Standard Deviation 0.34
|
-0.146 grams/minute
Standard Deviation 0.14
|
-0.052 grams/minute
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: baseline vs 12 weeks post-injectionsaliva collected over 5 minutes and weighed to produce a grams/minute "rate"
Outcome measures
| Measure |
1500U Myobloc
n=14 Participants
1500U Myobloc
|
2500U Myobloc
n=12 Participants
2500U Myobloc
|
3500U Myobloc
n=13 Participants
3500U Myobloc
|
Placebo
n=14 Participants
Placebo
|
|---|---|---|---|---|
|
Change in Unstimulated Salivary Flow Rate at Wk 12 Post-injection
|
-0.414 grams/minute
Standard Deviation 0.37
|
-0.166 grams/minute
Standard Deviation 0.31
|
-0.028 grams/minute
Standard Deviation 0.21
|
0.108 grams/minute
Standard Deviation 0.35
|
Adverse Events
1500U Myobloc
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
2500U Myobloc
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
3500U Myobloc
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1500U Myobloc
1500U Myobloc
|
2500U Myobloc
2500U Myobloc
|
3500U Myobloc
3500U Myobloc
|
Placebo
Placebo
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/14
|
0.00%
0/12
|
7.7%
1/13 • Number of events 1
|
0.00%
0/15
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/13
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Rectal Hemmorhage
|
0.00%
0/14
|
8.3%
1/12 • Number of events 1
|
0.00%
0/13
|
0.00%
0/15
|
|
Infections and infestations
Urosepsis
|
0.00%
0/14
|
0.00%
0/12
|
7.7%
1/13 • Number of events 1
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/13
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/13
|
6.7%
1/15 • Number of events 1
|
Other adverse events
| Measure |
1500U Myobloc
1500U Myobloc
|
2500U Myobloc
2500U Myobloc
|
3500U Myobloc
3500U Myobloc
|
Placebo
Placebo
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dry Mouth
|
7.1%
1/14 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
7.7%
1/13 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
Breath Odor
|
7.1%
1/14 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
7.7%
1/13 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
Saliva Altered
|
7.1%
1/14 • Number of events 1
|
0.00%
0/12
|
0.00%
0/13
|
0.00%
0/15
|
|
Gastrointestinal disorders
Tongue Coated
|
7.1%
1/14 • Number of events 1
|
0.00%
0/12
|
0.00%
0/13
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/14
|
8.3%
1/12 • Number of events 1
|
0.00%
0/13
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
7.1%
1/14 • Number of events 1
|
0.00%
0/12
|
0.00%
0/13
|
0.00%
0/15
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/14
|
0.00%
0/12
|
7.7%
1/13 • Number of events 1
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/13
|
6.7%
1/15 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Individual investigators may publish results 1 year after the completion of the trial if a multi-center publication has not occurred.
- Publication restrictions are in place
Restriction type: OTHER