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

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

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.

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