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

Drooling Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00515437
• Other study ID #: SN-SIAL-201
• Status: Completed
• Phase: Phase 2
• Start date: July 2007
• Est. completion date: September 2008

Study information

• Verified date: April 2019
• Source: US WorldMeds LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Drooling
• Parkinson Disease
• Sialorrhea

Intervention

Biological:
• Botulinum Toxin Type B (Myobloc)

• Matched placebo to Myobloc

Locations

Country	Name	City	State
United States	Dr. Eric Molho	Albany	New York
United States	Dr. Alan Freeman	Atlanta	Georgia
United States	Dr. Stephen Reich	Baltimore	Maryland
United States	Dr. Vanessa Hinson	Charleston	South Carolina
United States	Dr. Katie Kompoliti	Chicago	Illinois
United States	Dr. Madhavi Thomas	Dallas	Texas
United States	Dr. Olga Klepitskaya	Denver	Colorado
United States	Dr Hubert Fernandez	Gainesville	Florida
United States	Dr. Robert Rodnitzky	Iowa City	Iowa
United States	Dr. Sam Kabbani	Knoxville	Tennessee
United States	Dr. Ronald Ziman	Northridge	California
United States	Dr. James Sutton	Oxnard	California
United States	Dr. Brad Racette	Saint Louis	Missouri
United States	Dr. Gordon Smith	Salt Lake City	Utah
United States	Dr Virgilio Evidente	Scottsdale	Arizona
United States	Dr. Patrick Hogan	Tacoma	Washington
United States	Dr. Joseph Friedman	Warwick	Rhode Island
United States	Dr. Fernando Pagan	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Solstice Neurosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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