Trial Outcomes & Findings for Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism (NCT NCT01653132)
NCT ID: NCT01653132
Last Updated: 2017-03-14
Results Overview
Change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.
COMPLETED
PHASE2
10 participants
baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period
2017-03-14
Participant Flow
Subjects with Parkinson's disease/ parkinsonism with troublesome sialorrhea were recruited from the Movement Disorders clinic at Beth Israel Deaconess Medical Center, Boston, and by providing information to neurologists around the Boston area. Ten subjects were recruited between 9/5/2012 and 2/26/2014. The last study visit was completed on 9/5/14
17 subjects were assessed; 7 were excluded because they did not meet study criteria. This was a cross over study; all subjects received both placebo and Incobotulinum toxin injections and were followed up for 3 months after each injection. Washout period was 1-2 months, saliva weight had to be ≥ (baseline- 0.5 SD), to receive the second injection
Participant milestones
| Measure |
Placebo First, Then Incobotulinum Toxin A
sterile, preservative free 0.9% saline, 1 ml of saline into the parotid and submandibular glands in first intervention period
|
Incobotulinum Toxin A First, Then Placebo
Incobotulinum toxin, 100 units, diluted in 1 ml 0.9% sterile saline. 20 units (0.2 ml) were injected into each parotid gland and 30 units (0.3 ml) into each submandibular gland using anatomical landmarks
|
|---|---|---|
|
First Intervention
STARTED
|
5
|
5
|
|
First Intervention
COMPLETED
|
4
|
5
|
|
First Intervention
NOT COMPLETED
|
1
|
0
|
|
Washout 1-2 Months
STARTED
|
4
|
5
|
|
Washout 1-2 Months
COMPLETED
|
4
|
5
|
|
Washout 1-2 Months
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
4
|
5
|
|
Second Intervention
COMPLETED
|
4
|
5
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo First, Then Incobotulinum Toxin A
sterile, preservative free 0.9% saline, 1 ml of saline into the parotid and submandibular glands in first intervention period
|
Incobotulinum Toxin A First, Then Placebo
Incobotulinum toxin, 100 units, diluted in 1 ml 0.9% sterile saline. 20 units (0.2 ml) were injected into each parotid gland and 30 units (0.3 ml) into each submandibular gland using anatomical landmarks
|
|---|---|---|
|
First Intervention
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism
Baseline characteristics by cohort
| Measure |
All Study Participants
n=9 Participants
Participants who received either Placebo, 1ml of preservative free sterile 0.9% saline, injected into the parotid (0.2 ml each) and submandibular ( 0.3 ml each), or Incobotulinum Toxin A 100 units, 20 units (0.2 ml) of Inco-A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland using anatomical landmarks
|
|---|---|
|
Age, Continuous
|
68.1 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
|
UPDRS
|
8.4 units on a scale
n=5 Participants
|
|
DFSS
|
6 units on a scale
n=5 Participants
|
|
saliva weight
|
2.13 gms
STANDARD_DEVIATION 4.19 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo periodChange in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.
Outcome measures
| Measure |
Placebo
n=9 Participants
Sterile, preservative free 0.9% saline, 1 ml, injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
|
Incobotulinum Toxin A
n=9 Participants
Inco-A, 100 units was reconstituted with 1 ml 0.9% sterile saline (dilution: 10 units/0.1 ml). Twenty units (0.2 ml) of Inco-A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland using anatomical landmarks
|
|---|---|---|
|
Objectively Measured Salivary Weight
|
-0.07 gm
Standard Deviation 1.21
|
-0.68 gm
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo periodPercentage change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.
Outcome measures
| Measure |
Placebo
n=9 Participants
Sterile, preservative free 0.9% saline, 1 ml, injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
|
Incobotulinum Toxin A
n=9 Participants
Inco-A, 100 units was reconstituted with 1 ml 0.9% sterile saline (dilution: 10 units/0.1 ml). Twenty units (0.2 ml) of Inco-A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland using anatomical landmarks
|
|---|---|---|
|
Objectively Measured Percentage Salivary Weight
|
-7 percentage change from baseline
Standard Deviation 121
|
-67 percentage change from baseline
Standard Deviation 239
|
SECONDARY outcome
Timeframe: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo periodmeasured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.Drooling Frequency and Severity Score. The Drooling Score equals the sum of the Severity and Frequency sub-scores. The range is 2-9, higher numbers represent worse drooling Drooling Severity Scale 1. = Never drools, dry 2. = Mild-drooling, only lips wet 3. = Moderate- drool reaches the lips and chin 4. = Severe- drool drips off chin \& onto clothing 5. = Profuse- drooling off the body and onto objects (furniture, books) Drooling Frequency Scale 1\. = No drooling 2. = Occasionally drools 3. = Frequently drools 4. = Constant drooling
Outcome measures
| Measure |
Placebo
n=9 Participants
Sterile, preservative free 0.9% saline, 1 ml, injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
|
Incobotulinum Toxin A
n=9 Participants
Inco-A, 100 units was reconstituted with 1 ml 0.9% sterile saline (dilution: 10 units/0.1 ml). Twenty units (0.2 ml) of Inco-A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland using anatomical landmarks
|
|---|---|---|
|
Change in Drooling Frequency and Severity Scale (DFSS) Scores
|
-1 units on a scale
Standard Deviation 1.41
|
-0.67 units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo periodmeasured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.
Outcome measures
| Measure |
Placebo
n=9 Participants
Sterile, preservative free 0.9% saline, 1 ml, injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
|
Incobotulinum Toxin A
n=9 Participants
Inco-A, 100 units was reconstituted with 1 ml 0.9% sterile saline (dilution: 10 units/0.1 ml). Twenty units (0.2 ml) of Inco-A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland using anatomical landmarks
|
|---|---|---|
|
Number of Participants With Response, Defined as Subjects With ≥ 2 Point Improvement in the DFSS Scores.
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo periodmeasured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period
Outcome measures
| Measure |
Placebo
n=9 Participants
Sterile, preservative free 0.9% saline, 1 ml, injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
|
Incobotulinum Toxin A
n=9 Participants
Inco-A, 100 units was reconstituted with 1 ml 0.9% sterile saline (dilution: 10 units/0.1 ml). Twenty units (0.2 ml) of Inco-A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland using anatomical landmarks
|
|---|---|---|
|
Number of Participants With Response, Defined as Subjects With ≥ 20% Reduction in Saliva Volume.
|
3 participants
|
2 participants
|
Adverse Events
Incobotulinum Toxin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Incobotulinum Toxin
n=9 participants at risk
Incobotulinum Toxin 100 units diluted in 1 ml of sterile 0.9% saline injected in the parotid (20 units, 0.2 ml each) and submandibular (30 units, 0.3ml each) glands of subjects
|
Placebo
n=9 participants at risk；n=10 participants at risk
Sterile, preservative free 0.9% saline, 1 mL injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
|
|---|---|---|
|
Gastrointestinal disorders
chewing difficulty
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected for each subject at monthly visits for the duration of the study, 7-8 months per subject
all subjects were asked at each monthly visit if they had experienced any adverse events since the previous visit. If they responded yes, a checklist of common and rare side effects was used to query subjects, their adverse events were recorded in a standardized fashion and reported to the Committee for Clinical Investigations as per regulations
|
0.00%
0/9 • Adverse events data were collected for each subject at monthly visits for the duration of the study, 7-8 months per subject
all subjects were asked at each monthly visit if they had experienced any adverse events since the previous visit. If they responded yes, a checklist of common and rare side effects was used to query subjects, their adverse events were recorded in a standardized fashion and reported to the Committee for Clinical Investigations as per regulations
|
|
Gastrointestinal disorders
viscous saliva
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected for each subject at monthly visits for the duration of the study, 7-8 months per subject
all subjects were asked at each monthly visit if they had experienced any adverse events since the previous visit. If they responded yes, a checklist of common and rare side effects was used to query subjects, their adverse events were recorded in a standardized fashion and reported to the Committee for Clinical Investigations as per regulations
|
0.00%
0/9 • Adverse events data were collected for each subject at monthly visits for the duration of the study, 7-8 months per subject
all subjects were asked at each monthly visit if they had experienced any adverse events since the previous visit. If they responded yes, a checklist of common and rare side effects was used to query subjects, their adverse events were recorded in a standardized fashion and reported to the Committee for Clinical Investigations as per regulations
|
Additional Information
Dr. Pushpa Narayanaswami
Beth Israel Deaconess Medical center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place