SialorrheaPhase 2NCT01653132
Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism
A Phase 2 study testing Incobotulinum Toxin A in people with Sialorrhea, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sialorrhea
- What is being tested?
- Incobotulinum Toxin A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Sep 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Swallowing function: Functional Oral Intake Scale (FOIS)* of 5 or greater
- 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.
- 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.
- Women of child bearing age will need to be on a reliable method of birth control for the duration of the study.
Who cannot join
- For PD:
- Current use of Coumadin
- Concurrent significant medical illness
- History of myasthenia gravis or Lambert-Eaton Syndrome
- Ongoing substance abuse
- History of unreliable follow-up
- Past use of Xeomin® or other botulinum toxin preparations
- Cognitive impairment, defined as a score ≤ 23/30 on the Mini Mental Status Exam
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Randomized Double Blind Placebo Controlled Cross-Over Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism
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.
Read the detailed description
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.
- Conditions
- Sialorrhea
- Being tested
- Incobotulinum Toxin A, Placebo
- Keywords
- PD
- Medical subject headings
- Sialorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incobotulinum Toxin ADrug
Also called Xeomin
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
PlaceboDrug
Also called Saline
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 .
| Study group | Role | What they receive |
|---|---|---|
| Incobotulinum Toxin A | Experimental | 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 Receives: Drug: Incobotulinum Toxin A |
| Placebo | Placebo comparator | 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 . Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period
Secondary outcomes (3)
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
- = Never drools, dry
- = Mild-drooling, only lips wet
- = Moderate- drool reaches the lips and chin
- = Severe- drool drips off chin \& onto clothing
- = Profuse- drooling off the body and onto objects (furniture, books) Drooling Frequency Scale
- = No drooling 2. = Occasionally drools 3. = Frequently drools 4. = Constant drooling
Measured: 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.
Measured: 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
Measured: between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SialorrheaStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pushpa Narayanaswami, Beth Israel Deaconess Medical Center
- Investigators
- Pushpa Narayanaswami, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653132
- Sponsor's protocol ID
- 2011P00304
- Status last verified
- Feb 2017
- First submitted
- 25 Jul 2012
- Last updated
- 14 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Placebo Controlled Cross-Over Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism
- ClinicalTrials.gov ID
- NCT01653132
- Acronym / sponsor ID
- 2011P00304
- Conditions
- Sialorrhea
- Keywords
- PD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 30 Jul 2012 (estimated)
- Results
- Posted 14 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incobotulinum Toxin A | Experimental | Drug: Incobotulinum Toxin ATwenty 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 |
| Placebo | Placebo comparator | Drug: PlaceboSterile, 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 . |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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**.
Key exclusion criteria (8 listed)
- For PD:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incobotulinum Toxin AAlso: XeominTwenty 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 | Drug | Incobotulinum Toxin A |
| PlaceboAlso: SalineSterile, 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 |
Primary outcome
Objectively Measured Salivary Weight
Time frame: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period
Change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.
Objectively Measured Percentage Salivary Weight
Time frame: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period
Percentage change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.
3 secondary outcomes
Change in Drooling Frequency and Severity Scale (DFSS) Scores
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.
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.
Time frame: between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Sialorrhea
Active, not recruiting
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Cerebral Palsy (CP)
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Effects of Transcutaneous Vagus Nerve Stimulation in Parkinson´s Disease
Transcutaneous Vagal Nerve Stimulation (tVNS), Parkinson Disease (PD)
Recruiting
Application of Neuro-electrostimulation as a Treatment for Patients With Dry Mouth
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Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Cerebral Palsy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pushpa Narayanaswami, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Incobotulinum Toxin A in people with Sialorrhea, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objectively Measured Salivary Weight (time frame: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2017.