Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-01 @ 11:18 AM
Study NCT ID:
NCT01653132
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2012-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012798', 'term': 'Sialorrhea'}], 'ancestors': [{'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545476', 'term': 'incobotulinumtoxinA'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pnarayan@bidmc.harvard.edu', 'phone': '617-667-8130', 'title': 'Dr. Pushpa Narayanaswami', 'organization': 'Beth Israel Deaconess Medical center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events data were collected for each subject at monthly visits for the duration of the study, 7-8 months per subject', 'description': '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', 'eventGroups': [{'id': 'EG000', 'title': 'Incobotulinum Toxin', 'description': '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', 'otherNumAtRisk': 9, 'otherNumAffected': 2, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Sterile, preservative free 0.9% saline, 1 mL injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'chewing difficulty', 'notes': 'difficulty in chewing, a sensation of swelling inside the cheeks, a tendency to bite the inside of her cheeks and difficulty with motor control of the tongue, mild, resolved in 4-6 weeks without intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'viscous saliva', 'notes': 'viscous, thick saliva, mild, resolved in 4-6 weeks without intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objectively Measured Salivary Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Sterile, preservative free 0.9% saline, 1 ml, injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .'}, {'id': 'OG001', 'title': 'Incobotulinum Toxin A', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.07', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.194', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '0.32', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.61', 'estimateComment': 'negative values correspond to a reduction in saliva weight with Inco-A.', 'groupDescription': 'Based on the primary outcome measure of mean reduction in saliva weight at 1 month post Inco-A /placebo as compared to baseline, using paired t-test with a two-sided nominal significance (alpha) of 0.05, assuming a correlation of 0.5 between observations, a sample size of 10 pairs has a power of 0.803 to detect a 50% difference in salivary weight.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period', 'description': 'Change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.', 'unitOfMeasure': 'gm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Objectively Measured Percentage Salivary Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Sterile, preservative free 0.9% saline, 1 ml, injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .'}, {'id': 'OG001', 'title': 'Incobotulinum Toxin A', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '-7', 'spread': '121', 'groupId': 'OG000'}, {'value': '-67', 'spread': '239', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.3', 'ciLowerLimit': '-50.8', 'ciUpperLimit': '6.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.34', 'estimateComment': 'negative numbers represent reduction in saliva weight with Inco-A', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period', 'description': 'Percentage change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.', 'unitOfMeasure': 'percentage change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Drooling Frequency and Severity Scale (DFSS) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Incobotulinum Toxin', 'description': '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'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: 1ml of preservative free sterile 0.9% saline, injected into the parotid (0.2 ml each)and submandibular ( 0.3ml each) glands of subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '-1', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '0.69', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.41', 'estimateComment': 'negative values represent reduction in scores (improvement in drooling) with Inco-A', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period', 'description': 'measured 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\n\n1. = Never drools, dry\n2. = Mild-drooling, only lips wet\n3. = Moderate- drool reaches the lips and chin\n4. = Severe- drool drips off chin \\& onto clothing\n5. = Profuse- drooling off the body and onto objects (furniture, books) Drooling Frequency Scale\n\n1\\. = No drooling 2. = Occasionally drools 3. = Frequently drools 4. = Constant drooling', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Response, Defined as Subjects With ≥ 2 Point Improvement in the DFSS Scores.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Incobotulinum Toxin A', 'description': 'Twenty units (0.2 ml) of incobotulinum toxin A injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland for a total dose of 100 units using anatomical landmarks\n\nIncobotulinum Toxin A: Twenty units (0.2 ml) of incobotulinum toxin A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland for a total dose of 100 units using anatomical landmarks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sterile, preservative free 0.9% saline, 1 ml, was used as placebo, and injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .\n\nPlacebo: Sterile, preservative free 0.9% saline, 1 ml, was used as placebo, and injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.333', 'ciLowerLimit': '-0.633', 'ciUpperLimit': '0.071', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period', 'description': 'measured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Response, Defined as Subjects With ≥ 20% Reduction in Saliva Volume.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Incobotulinum Toxin', 'description': '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'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: 1ml of preservative free sterile 0.9% saline, injected into the parotid (0.2 ml each)and submandibular ( 0.3ml each) glands of subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.28', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period', 'description': 'measured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo First, Then Incobotulinum Toxin A', 'description': 'sterile, preservative free 0.9% saline, 1 ml of saline into the parotid and submandibular glands in first intervention period'}, {'id': 'FG001', 'title': 'Incobotulinum Toxin A First, Then Placebo', 'description': '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'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'one dropped out: wanted to start anticholinergic drug for tremor that could affect saliva volume', 'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout 1-2 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "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", 'preAssignmentDetails': '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'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': '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'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.1', 'spread': '9.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'UPDRS', 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'groupId': 'BG000', 'lowerLimit': '7', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'description': "Unified Parkinsons Disease Rating Scale. The UPDRS is a rating tool to follow the longitudinal course of Parkinson's Disease. It is made up of the 1) Mentation, Behavior, and Mood, 2) Activities of Daily Living and 3) Motor sections. These are evaluated by interview. We used UPDRS, Part 2 Questions 5,6,7 evaluating speech, salivation and swallowing and Part 3 questions 18 and 19 for motor examination of speech and facial expression. The scores for these sections were summed to obtain the total score. The range possible is 0- 20, with 20 reflecting worse disability", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'DFSS', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000', 'lowerLimit': '6', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'description': 'Drooling Frequency and Severity Score:\n\nThe Drooling Score equals the sum of the Severity and Frequency sub-scores.The total score ranges from 2 to 9, with higher scores indicating more severe and frequent drooling\n\nDrooling Severity Scale\n\n1. = Never drools, dry\n2. = Mild-drooling, only lips wet\n3. = Moderate- drool reaches the lips and chin\n4. = Severe- drool drips off chin \\& onto clothing\n5. = Profuse- drooling off the body and onto objects (furniture, books)\n\nDrooling Frequency Scale\n\n1. = No drooling\n2. = Occasionally drools\n3. = Frequently drools\n4. = Constant drooling', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'saliva weight', 'classes': [{'categories': [{'measurements': [{'value': '2.13', 'spread': '4.19', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'gms', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Ten subjects were recruited; nine completed both periods of the study. One subject dropped out after the first injection because he wanted to start anticholinergics for symptomatic treatment of tremor, and this was an exclusion criterion. His data was excluded.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-03', 'studyFirstSubmitDate': '2012-07-25', 'resultsFirstSubmitDate': '2016-03-10', 'studyFirstSubmitQcDate': '2012-07-27', 'lastUpdatePostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-24', 'studyFirstPostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objectively Measured Salivary Weight', 'timeFrame': 'baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period', 'description': 'Change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.'}, {'measure': 'Objectively Measured Percentage Salivary Weight', 'timeFrame': 'baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period', 'description': 'Percentage change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.'}], 'secondaryOutcomes': [{'measure': 'Change in Drooling Frequency and Severity Scale (DFSS) Scores', 'timeFrame': 'baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period', 'description': 'measured 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\n\n1. = Never drools, dry\n2. = Mild-drooling, only lips wet\n3. = Moderate- drool reaches the lips and chin\n4. = Severe- drool drips off chin \\& onto clothing\n5. = Profuse- drooling off the body and onto objects (furniture, books) Drooling Frequency Scale\n\n1\\. = No drooling 2. = Occasionally drools 3. = Frequently drools 4. = Constant drooling'}, {'measure': 'Number of Participants With Response, Defined as Subjects With ≥ 2 Point Improvement in the DFSS Scores.', 'timeFrame': 'baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period', 'description': 'measured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.'}, {'measure': 'Number of Participants With Response, Defined as Subjects With ≥ 20% Reduction in Saliva Volume.', 'timeFrame': 'between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period', 'description': 'measured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PD'], 'conditions': ['Sialorrhea']}, 'descriptionModule': {'briefSummary': "This study is being conducted this study to determine whether injections of Xeomin®, a type of botulinum toxin into the glands that produce saliva (one pair just below and in front of the ear and the other just under the jaw line) are safe and effective to treat excessive saliva, or drooling in patients with Parkinson's Disease (PD)/parkinsonism.", 'detailedDescription': 'Participants will be recruited if they have Parkinson\'s disease, Parkinsonism. Inclusion and exclusion criteria are summarized below. Participants will be screened at the first visit to make sure they are eligible for the trial. They will then undergo baseline testing including neurologic evaluation, questions to assess their memory and cognitive status and evaluation of their disease status using parts of the Unified Parkinsons\'s Disease Ratings Scale (UPDRS) that are routinely used to follow disease progression. They will be given a questionnaire to evaluate the severity of their drooling. Their saliva production will be measured by having them spit into a cup for 5 minutes, twice.\n\nAt the first visit, after making sure they are eligible for the study and performing the baseline testing and procedures, they will be given either Xeomin or placebo (saline injections without medication) injections in the 4 glands that produce saliva. They will not know which injection they received. This visit will take about 2 hours. They will be followed up every month and asked about side effects, have neurologic evaluation and UPDRS testing and fill-in the questionnaire for drooling severity. Saliva volume will be measured as done at the first visit. At either Month 4 or 5, participants will receive the second injection. This will be a "cross-over" injection, i.e., if they received Xeomin at the first injection they will receive saline at the second and vice versa. Thus, all participants will receive the study medication Xeomin, either as the first injection or the second injection at 4 months or 5 months. The follow up after the second injection will be one monthly visit for 3 months, with similar evaluations as described above. The follow-up visit will take about 1 hour each.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For PD/ Parkinsonism: 1. PD, Multiple Systems Atrophy (MSA), or Progressive Supranuclear Palsy (PSP) diagnosed by clinical criteria, ages 20-80 with troublesome sialorrhea as defined below\\*\\*.\n\n * Sialorrhea that patients or their families or treating physicians think is troublesome\n\n 1. Swallowing function: Functional Oral Intake Scale (FOIS)\\* of 5 or greater\n 2. If patients have been treated with other medications for sialorrhea earlier, they should be off the medications at least 4 weeks prior to the baseline evaluation.\n 3. If they are on other medications for sialorrhea at the time of the baseline evaluation, the doses will be held stable throughout the period of the study.\n 4. Women of child bearing age will need to be on a reliable method of birth control for the duration of the study.\n\nExclusion Criteria:\n\n* For PD:\n\n 1. Current use of Coumadin\n 2. Concurrent significant medical illness\n 3. History of myasthenia gravis or Lambert-Eaton Syndrome\n 4. Ongoing substance abuse\n 5. History of unreliable follow-up\n 6. Past use of Xeomin® or other botulinum toxin preparations\n 7. Cognitive impairment, defined as a score ≤ 23/30 on the Mini Mental Status Exam'}, 'identificationModule': {'nctId': 'NCT01653132', 'briefTitle': "Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism", 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': "Randomized Double Blind Placebo Controlled Cross-Over Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism", 'orgStudyIdInfo': {'id': '2011P00304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Incobotulinum Toxin A', 'description': 'Twenty units (0.2 ml) of incobotulinum toxin A injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland for a total dose of 100 units using anatomical landmarks', 'interventionNames': ['Drug: Incobotulinum Toxin A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Sterile, preservative free 0.9% saline, 1 ml, was used as placebo, and injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Incobotulinum Toxin A', 'type': 'DRUG', 'otherNames': ['Xeomin'], 'description': 'Twenty units (0.2 ml) of incobotulinum toxin A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland for a total dose of 100 units using anatomical landmarks', 'armGroupLabels': ['Incobotulinum Toxin A']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': 'Sterile, preservative free 0.9% saline, 1 ml, was used as placebo, and injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Pushpa Narayanaswami, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Neurology', 'investigatorFullName': 'Pushpa Narayanaswami', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}