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

April 29, 2019 updated by: Solstice Neurosciences

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Dr Virgilio Evidente
    • California
      • Northridge, California, United States, 91325
        • Dr. Ronald Ziman
      • Oxnard, California, United States, 93030
        • Dr. James Sutton
    • Colorado
      • Denver, Colorado, United States, 80262
        • Dr. Olga Klepitskaya
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Dr. Fernando Pagan
    • Florida
      • Gainesville, Florida, United States, 32610
        • Dr Hubert Fernandez
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Dr. Alan Freeman
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Dr. Katie Kompoliti
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Dr. Robert Rodnitzky
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Dr. Stephen Reich
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Dr. Brad Racette
    • New York
      • Albany, New York, United States, 12205
        • Dr. Eric Molho
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Dr. Joseph Friedman
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Dr. Vanessa Hinson
    • Tennessee
      • Knoxville, Tennessee, United States, 37923
        • Dr. Sam Kabbani
    • Texas
      • Dallas, Texas, United States, 75231
        • Dr. Madhavi Thomas
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Dr. Gordon Smith
    • Washington
      • Tacoma, Washington, United States, 98405
        • Dr. Patrick Hogan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
1500U Myobloc
Biological: Botulinum Toxin Type B (Myobloc)
Experimental: 2
2500U Myobloc
Biological: Botulinum Toxin Type B (Myobloc)
Experimental: 3
3500U Myobloc
Biological: Botulinum Toxin Type B (Myobloc)
Placebo Comparator: 4
pooled placebo
Biological: Matched placebo to Myobloc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection
Time Frame: baseline versus 4 weeks post-injection
9 point scale, 0 = no drooling, 9 = severe drooling
baseline versus 4 weeks post-injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection
Time Frame: baseline vs 12 weeks post injection
9 point scale (0=no drooling, 9=severe drooling)
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
saliva is collected over 5 minutes and weighed to produce a grams/minute "rate"
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
saliva collected over 5 minutes and weighed to produce a grams/minute "rate"
baseline vs 12 weeks post-injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solstice Neurosciences

Investigators

  • Study Director: Eric Pappert, MD, Solstice Neurosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

August 10, 2007

First Submitted That Met QC Criteria

August 10, 2007

First Posted (Estimate)

August 13, 2007

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

April 29, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SN-SIAL-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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