Clinical Trial: A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Sial
Brief Summary: To determine safety, tolerability and preliminary efficacy of intraglandular injections of MYOBLOC for the treatment of sialorrhea in Parkinsons' Disease patients
Detailed Summary: 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.
Sponsor: Solstice Neurosciences
Current Primary Outcome: Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-Injection [ Time Frame: baseline versus 4 weeks post-injection ]
Original Primary Outcome: Safety & Tolerability Endpoints [ Time Frame: measured over 20 weeks ]
Current Secondary Outcome:
- Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-Injection [ Time Frame: baseline vs 12 weeks post injection ]
- Change in Unstimulated Salivary Flow Rate at Wk 4 Post-Injection [ Time Frame: baseline vs 4 weeks post-injection ]
- Change in Unstimulated Salivary Flow Rate at Wk 12 Post-Injection [ Time Frame: baseline vs 12 weeks post-injection ]
Original Secondary Outcome: Preliminary Efficacy scales [ Time Frame: measured over 20 weeks ]
Information By: Solstice Neurosciences
Dates:
Date Received: August 10, 2007
Date Started: July 2007
Date Completion:
Last Updated: June 30, 2009
Last Verified: June 2009
