Clinical trial NCT00515437: A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Drooling
Keywords: Sialorrhea
Lead sponsor: USWM, LLC (dba US WorldMeds)
Sponsor class: INDUSTRY
First posted: 2007-08-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection
timeFrame: baseline versus 4 weeks post-injection
Secondary outcomes:
measure: Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection
timeFrame: baseline vs 12 weeks post injection
measure: Change in Unstimulated Salivary Flow Rate at Wk 4 Post-injection
timeFrame: baseline vs 4 weeks post-injection
measure: Change in Unstimulated Salivary Flow Rate at Wk 12 Post-injection
timeFrame: baseline vs 12 weeks post-injection
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Dr Virgilio Evidente
state: Arizona
city: Northridge
country: United States
facility: Dr. Ronald Ziman
state: California
city: Oxnard
country: United States
facility: Dr. James Sutton
state: California
city: Denver
country: United States
facility: Dr. Olga Klepitskaya
state: Colorado
city: Washington
country: United States
facility: Dr. Fernando Pagan
state: District of Columbia
city: Gainesville
country: United States
facility: Dr Hubert Fernandez
state: Florida
city: Atlanta
country: United States
facility: Dr. Alan Freeman
state: Georgia
city: Chicago
country: United States
facility: Dr. Katie Kompoliti
state: Illinois
city: Iowa City
country: United States
facility: Dr. Robert Rodnitzky
state: Iowa
city: Baltimore
country: United States
facility: Dr. Stephen Reich
state: Maryland
city: Saint Louis
country: United States
facility: Dr. Brad Racette
state: Missouri
city: Albany
country: United States
facility: Dr. Eric Molho
state: New York
city: Warwick
country: United States
facility: Dr. Joseph Friedman
state: Rhode Island
city: Charleston
country: United States
facility: Dr. Vanessa Hinson
state: South Carolina
city: Knoxville
country: United States
facility: Dr. Sam Kabbani
state: Tennessee
city: Dallas
country: United States
facility: Dr. Madhavi Thomas
state: Texas
city: Salt Lake City
country: United States
facility: Dr. Gordon Smith
state: Utah
city: Tacoma
country: United States
facility: Dr. Patrick Hogan
state: Washington
Study officials:
affiliation: Solstice Neurosciences
name: Eric Pappert, MD
role: STUDY_DIRECTOR
References: