A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients

Solstice Neurosciences54 enrolled

Overview

To determine safety, tolerability and preliminary efficacy of intraglandular injections of MYOBLOC for the treatment of sialorrhea in Parkinsons' Disease patients

This is a multi-center, outpatient, double-blind, placebo-controlled, single treatment, sequential dose escalation study designed to evaluate the safety, tolerability and preliminary efficacy of single doses of MYOBLOC versus placebo for the treatment of sialorrhea in Parkinson's disease patients, lasting approximately 20 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Drooling

Interventions

Botulinum Toxin Type B (Myobloc)BIOLOGICAL

Matched placebo to MyoblocBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Parkinsons' Disease patients with Sialorrhea for at least 3 months Exclusion Criteria: * Patients with non-idiopathic PD parkinsonism * Patients previously exposed to botulinum toxins * Patients with a history of aspiration pneumonia, moderate/severe choking and/or moderate/severe dysphagia * Patients with prior salivary gland surgery

Locations (18)

Dr Virgilio Evidente

Scottsdale, Arizona, United States

Dr. Ronald Ziman

Northridge, California, United States

Outcomes

Primary Outcomes

Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection

9 point scale, 0 = no drooling, 9 = severe drooling

Time frame: baseline versus 4 weeks post-injection

Secondary Outcomes

Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection

9 point scale (0=no drooling, 9=severe drooling)

Time frame: baseline vs 12 weeks post injection

Change in Unstimulated Salivary Flow Rate at Wk 4 Post-injection

saliva is collected over 5 minutes and weighed to produce a grams/minute "rate"

Time frame: baseline vs 4 weeks post-injection

Change in Unstimulated Salivary Flow Rate at Wk 12 Post-injection

saliva collected over 5 minutes and weighed to produce a grams/minute "rate"

Time frame: baseline vs 12 weeks post-injection

Data from ClinicalTrials.gov

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