A Phase 2 interventional study of Incobotulinum Toxin A and Placebo in Sialorrhea, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-03-14.
Sponsored by Beth Israel Deaconess Medical Center · Phase 2, Interventional, and Treatment
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.
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.
At 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.
60 studies on the registry are indexed under Sialorrhea; 5 are open to participants now.
This study's enrollment of 10 is below the median of 31 across 44 interventional studies indexed under Sialorrhea.
Browse Sialorrhea studies →Beth Israel Deaconess Medical Center is the lead sponsor of 568 studies on the registry; 80 are open to participants now.
Of its 76 completed or terminated interventional studies of FDA-regulated products, 62 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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**.
Sialorrhea that patients or their families or treating physicians think is troublesome
Exclusion Criteria:
For PD:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Incobotulinum Toxin A
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 .
Drug: Placebo
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
Also known as: Xeomin
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 .
Also known as: Saline
Objectively Measured Salivary Weight
Change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.
Time frame: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period
Objectively Measured Percentage Salivary Weight
Percentage change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.
Time frame: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period
Change in Drooling Frequency and Severity Scale (DFSS) Scores
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 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
Time frame: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period
Number of Participants With Response, Defined as Subjects With ≥ 2 Point Improvement in the DFSS Scores.
measured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.
Time frame: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period
Number of Participants With Response, Defined as Subjects With ≥ 20% Reduction in Saliva Volume.
measured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period
Time frame: between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period
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
| Milestone | Placebo First, Then Incobotulinum Toxin A | Incobotulinum Toxin A First, Then Placebo |
|---|---|---|
| Started | 5 | 5 |
| Completed | 4 | 5 |
| Not completed | 1 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
| Milestone | Placebo First, Then Incobotulinum Toxin A | Incobotulinum Toxin A First, Then Placebo |
|---|---|---|
| Started | 4 | 5 |
| Completed | 4 | 5 |
| Not completed | 0 | 0 |
| Milestone | Placebo First, Then Incobotulinum Toxin A | Incobotulinum Toxin A First, Then Placebo |
|---|---|---|
| Started | 4 | 5 |
| Completed | 4 | 5 |
| Not completed | 0 | 0 |
Change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.
| gm | Placebo | Incobotulinum Toxin A |
|---|---|---|
| Objectively Measured Salivary Weight | -0.07 ± 1.21 | -0.68 ± 2.4 |
Percentage change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.
| percentage change from baseline | Placebo | Incobotulinum Toxin A |
|---|---|---|
| Objectively Measured Percentage Salivary Weight | -7 ± 121 | -67 ± 239 |
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 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
| units on a scale | Incobotulinum Toxin | Placebo |
|---|---|---|
| Change in Drooling Frequency and Severity Scale (DFSS) Scores | -1 ± 1.41 | -0.67 ± 0.7 |
measured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.
| participants | Incobotulinum Toxin A | Placebo |
|---|---|---|
| Number of Participants With Response, Defined as Subjects With ≥ 2 Point Improvement in the DFSS Scores. | 2 | 1 |
measured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period
| participants | Incobotulinum Toxin | Placebo |
|---|---|---|
| Number of Participants With Response, Defined as Subjects With ≥ 20% Reduction in Saliva Volume. | 3 | 2 |
Collected over Adverse events data were collected for each subject at monthly visits for the duration of the study, 7-8 months per subject. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Incobotulinum Toxin | — | 0/9 (0%) | 2/9 (22.2%) |
| Placebo | — | 0/10 (0%) | 0/9 (0%) |
| Event | Incobotulinum Toxin | Placebo |
|---|---|---|
| chewing difficultyGastrointestinal disorders | 1/9 | 0/9 |
| viscous salivaGastrointestinal disorders | 1/9 | 0/9 |
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.
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 68.1 ± 9.7 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 3 |
| Male | 6 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 9 |
| UPDRS(units on a scale) | All Study Participants |
|---|---|
| Median | 8.4 (7 to 9) |
| DFSS(units on a scale) | All Study Participants |
|---|---|
| Median | 6 (6 to 7) |
| saliva weight(gms) | All Study Participants |
|---|---|
| Mean | 2.13 ± 4.19 |
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Botulinum toxin type A
Beth Israel Deaconess Medical Center →