CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Incobotulinum Toxin A +1 moredrug
Likely dose
Incobotulinum Toxin A 0.2 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01653132
NCT01653132Phase 2Completed
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Randomized Double Blind Placebo Controlled Cross-Over Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism

Beth Israel Deaconess Medical Center·interventional·Posted Jul 30, 2012·Updated Mar 14, 2017

In Brief

A Phase 2 clinical trial evaluating Incobotulinum Toxin A and Placebo for Sialorrhea. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSialorrhea
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 30, 2012
Enrollment StartMar 1, 2012
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 13.9 years ago

Interventions

Incobotulinum Toxin Adrug

Twenty units (0.2 ml) of incobotulinum toxin A were 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

Placebodrug

Sterile, preservative free 0.9% saline, 1 ml, was used as placebo, and injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .