Incobotulinum Toxin A for Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS) (Xeomin)
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| ClinicalTrials.gov Identifier: NCT01565395 |
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Recruitment Status :
Withdrawn
(Could not recruit ALS participants, hence ALS arm discontinued)
First Posted : March 28, 2012
Last Update Posted : February 7, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Parkinson Disease Amyotrophic Lateral Sclerosis | Drug: Incobotulinum Toxin A Drug: placebo | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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) |
| Study Start Date : | March 2012 |
| Actual Primary Completion Date : | July 2013 |
| Actual Study Completion Date : | July 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Xeomin Injections
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
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Drug: Incobotulinum Toxin A
Xeomin 70-100 units injected in the parotid and submandibular glands of subjects
Other Name: Xeomin |
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Placebo Comparator: Placebo
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
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Drug: placebo
Sterile preservative free 0.9% saline
Other Name: Saline |
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: Hypothesis: Xeomin® injections into the parotid and submandibular glands are safe and effective in the treatment of troublesome sialorrhea in patients with PD/Parkinsonism and ALS.
Inclusion criteria are as follows:
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.
Exclusion criteria
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565395
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: | Pushpa Narayanaswami, ME | Beth Israel Deaconess Medical Center |
| Responsible Party: | Pushpa Narayanaswami, Associate Professor of Neurology, Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT01565395 |
| Other Study ID Numbers: |
2011P000304 |
| First Posted: | March 28, 2012 Key Record Dates |
| Last Update Posted: | February 7, 2017 |
| Last Verified: | February 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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ALS PD |
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Sialorrhea Parkinson Disease Motor Neuron Disease Amyotrophic Lateral Sclerosis Parkinsonian Disorders Sclerosis Pathologic Processes Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Neuromuscular Diseases Spinal Cord Diseases |
TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases incobotulinumtoxinA Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents |