drugset / Trial / NCT01653132

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

NCT01653132 ↗

Phase 2 Completed 10 enrolled Beth Israel Deaconess Medical Center
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2012-03
Primary completion
2014-09
Completion
2014-09

Outcome

Missed primary endpoint

registry Mean Difference (Net) -0.194 (95% CI -0.71 to 0.32) NCT01653132 ↗

registry Mean Difference (Net) -22.3 (95% CI -50.8 to 6.2) NCT01653132 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 100 iu Other

Indications

No indication recorded.