WithdrawnPhase 2

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

Stopped: Could not recruit ALS participants, hence ALS arm discontinued

United States0Started 2012-03

Plain-language 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.

Who can participate

Age range20 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

✕. 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.

What they're measuring

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

Timeframe: 7 months

Trial details

NCT IDNCT01565395

SponsorBeth Israel Deaconess Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-07

View on ClinicalTrials.gov More Parkinson Disease trials