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

NCT01565395 | Withdrawn Phase 2

• 1 other identifier: 2011P000304
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease; Amyotrophic Lateral Sclerosis

Keywords

ALS; PD

Outcome Measures

Primary Outcomes (1)

• Change in objectively measured salivary volume between baseline and one month post-injection in the Xeomin group as compared to placebo

  7 months

Study Arms (2)

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

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

Drug: placebo

Interventions

Incobotulinum Toxin A DRUG

Xeomin 70-100 units injected in the parotid and submandibular glands of subjects

Also known as: Xeomin

Xeomin Injections

placebo DRUG

Sterile preservative free 0.9% saline

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Merz Pharmaceuticals: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Amyotrophic Lateral Sclerosis

Interventions

incobotulinumtoxinA; Sodium Chloride

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Spinal Cord Diseases; Motor Neuron Disease; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Pushpa Narayanaswami, ME

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: March 28, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 7, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)