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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Parkinson Disease, Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID

NCT01565395

Run by

Beth Israel Deaconess Medical Center

People needed

0

Starts

2012-03-01

Expected to finish

2013-07-01

Last updated by the study team

2017-02-07

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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