Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS) (Xeomin 2012)

This study has been withdrawn prior to enrollment.
(Could not recruit ALS participants, hence ALS arm discontinued)
Sponsor:
Collaborator:
MERZ Pharmaceuticals
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01565395
First received: March 26, 2012
Last updated: July 28, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention Phase
Parkinson Disease
Amyotrophic Lateral Sclerosis
Drug: Xeomin
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xeomin Injections
Xeomin 70-100 units injected into the parotid and submandibular glands
Drug: Xeomin
Xeomin 70-100 units injected in the parotid and submandibular glands of subjects
Placebo Comparator: Placebo Drug: placebo

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  1. Swallowing function: FOIS scale* 5 or greater (see appendix 1 for scale)
  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.
  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.
  4. 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:

  1. Current use of Coumadin
  2. Concurrent significant medical illness.
  3. History of myasthenia gravis or Lambert-Eaton Syndrome
  4. Ongoing substance abuse
  5. History of unreliable follow-up
  6. Past use of Xeomin® or other botulinum toxin preparations
  7. Cognitive impairment, defined as a score ≤ 23/30 on the Mini Mental Status Exam.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01565395

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
MERZ Pharmaceuticals
Investigators
Principal Investigator: Pushpa Narayanaswami, ME Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01565395     History of Changes
Other Study ID Numbers: 2011P-000304
Study First Received: March 26, 2012
Last Updated: July 28, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Beth Israel Deaconess Medical Center:
ALS
PD

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Parkinson Disease
Parkinsonian Disorders
Sclerosis
Sialorrhea
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Metabolic Diseases
Mouth Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Pathologic Processes
Proteostasis Deficiencies
Salivary Gland Diseases
Spinal Cord Diseases
Stomatognathic Diseases
TDP-43 Proteinopathies

ClinicalTrials.gov processed this record on August 04, 2015