Parkinson DiseasePhase 2XeominNCT01565395
Incobotulinum Toxin A for Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS)
A Phase 2 study testing Incobotulinum Toxin A in people with Parkinson Disease and Amyotrophic Lateral Sclerosis, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of Incobotulinum Toxin A (Xeomin®) injections into the parotid and submandibular glands in patients with Parkinson's Disease/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS) with troublesome sialorrhea. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Parkinson Disease, Amyotrophic Lateral Sclerosis
- What is being tested?
- Incobotulinum Toxin A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jul 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For ALS: 1. Patients diagnosed with ALS by el-Escorial Criteria, ages 20-80 with troublesome sialorrhea as defined below.
- 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.
- Troublesome sialorrhea is defined as grade 3 or more (grade 3 is marked excess of saliva with some drooling) or more on the UPDRS Part 2 Sialorrhea grading scale:[33] (Appendix 1)
- For both groups:
- Swallowing function: FOIS scale* 5 or greater (see appendix 1 for scale)
- 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 both PD and ALS:
- 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 and Amyotrophic Lateral Sclerosis (ALS)
The purpose of this study is to evaluate the safety and efficacy of Incobotulinum Toxin A (Xeomin®) injections into the parotid and submandibular glands in patients with Parkinson's Disease/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS) with troublesome sialorrhea.
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 ALS-FRS 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
- Parkinson Disease, Amyotrophic Lateral Sclerosis
- Being tested
- Incobotulinum Toxin A, placebo
- Keywords
- ALS, PD
- Medical subject headings
- Parkinson Disease, Amyotrophic Lateral Sclerosis
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
Xeomin 70-100 units injected in the parotid and submandibular glands of subjects
placeboDrug
Also called Saline
Sterile preservative free 0.9% saline
| Study group | Role | What they receive |
|---|---|---|
| Xeomin Injections | Experimental | Fifteen units (0.15 ml) of incobotulinum toxin A injected into each parotid gland and 20 units (0.2 ml) to each submandibular gland for a total dose of 70 units using anatomical landmarks for ALS Twenty units (0.2ml) 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 for PD/parkinsonism Receives: Drug: Incobotulinum Toxin A |
| Placebo | Placebo comparator | 0.15 ml sterile 0.9% saline injected into each parotid gland and 0.2 ml to each submandibular gland using anatomical landmarks for ALS 0.2ml injected into each parotid gland and 0.3 ml to each submandibular gland using anatomical landmarks for PD/parkinsonism Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in objectively measured salivary volume between baseline and one month post-injection in the Xeomin group as compared to placebo
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: Could not recruit ALS participants, hence ALS arm discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merz Pharmaceuticals
- Responsible party
- Principal investigator, Pushpa Narayanaswami, Beth Israel Deaconess Medical Center
- Investigators
- Pushpa Narayanaswami, ME, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565395
- Sponsor's protocol ID
- 2011P000304
- Acronym
- Xeomin
- Status last verified
- Feb 2017
- First submitted
- 26 Mar 2012
- Last updated
- 7 Feb 2017
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 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 and Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT01565395
- Acronym / sponsor ID
- Xeomin / 2011P000304
- Conditions
- Parkinson Disease, Amyotrophic Lateral Sclerosis
- Keywords
- ALS, PD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Could not recruit ALS participants, hence ALS arm discontinued
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Merz Pharmaceuticals
- Study start
- Mar 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 28 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of Incobotulinum Toxin A (Xeomin®) injections into the parotid and submandibular glands in patients with Parkinson's Disease/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS) with troublesome sialorrhea.
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 ALS-FRS 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
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xeomin Injections | Experimental | Drug: Incobotulinum Toxin AFifteen units (0.15 ml) of incobotulinum toxin A injected into each parotid gland and 20 units (0.2 ml) to each submandibular gland for a total dose of 70 units using anatomical landmarks for ALS Twenty units (0.2ml) 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 for PD/parkinsonism |
| Placebo | Placebo comparator | Drug: placebo0.15 ml sterile 0.9% saline injected into each parotid gland and 0.2 ml to each submandibular gland using anatomical landmarks for ALS 0.2ml injected into each parotid gland and 0.3 ml to each submandibular gland using anatomical landmarks for PD/parkinsonism |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- For ALS: 1. Patients diagnosed with ALS by el-Escorial Criteria, ages 20-80 with troublesome sialorrhea as defined below.
- 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.
- Troublesome sialorrhea is defined as grade 3 or more (grade 3 is marked excess of saliva with some drooling) or more on the UPDRS Part 2 Sialorrhea grading scale:[33] (Appendix 1)
- Swallowing function: FOIS scale* 5 or greater (see appendix 1 for scale)
- 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.
Key exclusion criteria (8 listed)
- Current use of Coumadin
- Concurrent significant medical illness.
- History of myasthenia gravis or Lambert-Eaton Syndrome
- Ongoing substance abuse
- History of unreliable follow-up
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: XeominXeomin 70-100 units injected in the parotid and submandibular glands of subjects | Drug | Xeomin Injections |
| placeboAlso: SalineSterile preservative free 0.9% saline | Drug | Placebo |
Primary outcome
Change in objectively measured salivary volume between baseline and one month post-injection in the Xeomin group as compared to placebo
Time frame: 7 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Individual participant dataSharing planned: No
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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, ME 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 Parkinson Disease and Amyotrophic Lateral Sclerosis, 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 8 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: withdrawn, as of the sponsor's last update on 7 Feb 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in objectively measured salivary volume between baseline and one month post-injection in the Xeomin group as compared to placebo (time frame: 7 months). 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 7 Feb 2017.