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

Study Overview
=================
Brief Summary
-----------------
To determine safety, tolerability and preliminary efficacy of intraglandular injections of MYOBLOC for the treatment of sialorrhea in Parkinsons' Disease patients

Detailed Description
-----------------
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.

Official Title
-----------------
A Multi-Center, Randomized, Double-blind, Placebo-Controlled,Sequential Dose Escalation, Safety, Tolerability, and Preliminary Efficacy Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients

Conditions
-----------------
Drooling

Intervention / Treatment
-----------------
* Biological: Botulinum Toxin Type B (Myobloc)
* Biological: Matched placebo to Myobloc


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>1500U Myobloc | Biological: Botulinum Toxin Type B (Myobloc)<br> <br> |
| Experimental: 2<br>2500U Myobloc | Biological: Botulinum Toxin Type B (Myobloc)<br> <br> |
| Experimental: 3<br>3500U Myobloc | Biological: Botulinum Toxin Type B (Myobloc)<br> <br> |
| Placebo Comparator: 4<br>pooled placebo | Biological: Matched placebo to Myobloc<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection | 9 point scale, 0 = no drooling, 9 = severe drooling | baseline versus 4 weeks post-injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection | 9 point scale (0=no drooling, 9=severe drooling) | 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 | 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 | baseline vs 12 weeks post-injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sialorrhea