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Neurotoxin

Xeomin Injections for Parkinson's Disease (Xeomin Trial)

Phase 2
Waitlist Available
Led By Pushpa Narayanaswami, ME
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 months
Awards & highlights

Xeomin Trial 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.

Eligible Conditions
  • Parkinson's Disease
  • Amyotrophic Lateral Sclerosis

Xeomin Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in objectively measured salivary volume between baseline and one month post-injection in the Xeomin group as compared to placebo

Side effects data

From 2014 Phase 2 trial • 10 Patients • NCT01653132
11%
viscous saliva
11%
chewing difficulty
100%
80%
60%
40%
20%
0%
Study treatment Arm
Incobotulinum Toxin
Placebo

Xeomin Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Xeomin InjectionsExperimental Treatment1 Intervention
Fifteen units (0.15 ml) of incobotulinum toxin A injected into each parotid gland and 20 units (0.2 ml) to each submandibular gland for a total dose of 70 units using anatomical landmarks for ALS Twenty units (0.2ml) 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 for PD/parkinsonism
Group II: PlaceboPlacebo Group1 Intervention
0.15 ml sterile 0.9% saline injected into each parotid gland and 0.2 ml to each submandibular gland using anatomical landmarks for ALS 0.2ml injected into each parotid gland and 0.3 ml to each submandibular gland using anatomical landmarks for PD/parkinsonism
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Botulinum toxin type A
FDA approved

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
840 Previous Clinical Trials
13,011,719 Total Patients Enrolled
Merz PharmaceuticalsIndustry Sponsor
5 Previous Clinical Trials
461 Total Patients Enrolled
Pushpa Narayanaswami, MEPrincipal InvestigatorBeth Israel Deaconess Medical Center
~0 spots leftby Jun 2025
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