CompletedPhase 2

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

United States54 participantsStarted 2007-07

Plain-language summary

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

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: baseline versus 4 weeks post-injection

Trial details

NCT IDNCT00515437

SponsorSolstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-06

Results submitted2009-05-12

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