CompletedPhase 2

Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism

United States10 participantsStarted 2012-03

Plain-language summary

This study is being conducted this study to determine whether injections of Xeomin®, a type of botulinum toxin into the glands that produce saliva (one pair just below and in front of the ear and the other just under the jaw line) are safe and effective to treat excessive saliva, or drooling in patients with Parkinson's Disease (PD)/parkinsonism.

Who can participate

Age range18 Years – 90 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: Functional Oral Intake Scale (FOIS)\* of 5 or greater
✓. 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

Objectively Measured Salivary Weight

Timeframe: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period

Objectively Measured Percentage Salivary Weight

Timeframe: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period

Trial details

NCT IDNCT01653132

SponsorBeth Israel Deaconess Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-09

Results submitted2016-03-10

View on ClinicalTrials.gov More Sialorrhea trials

Plain-language summary

Who can participate

Age range18 Years – 90 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: Functional Oral Intake Scale (FOIS)\* of 5 or greater
✓. 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

Objectively Measured Salivary Weight

Timeframe: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period

Objectively Measured Percentage Salivary Weight

Timeframe: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period