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

Primary Purpose

Drooling

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Botulinum Toxin Type B (Myobloc)
Matched placebo to Myobloc
Sponsored by
Solstice Neurosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drooling focused on measuring Sialorrhea

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr Virgilio Evidente
  • Dr. Ronald Ziman
  • Dr. James Sutton
  • Dr. Olga Klepitskaya
  • Dr. Fernando Pagan
  • Dr Hubert Fernandez
  • Dr. Alan Freeman
  • Dr. Katie Kompoliti
  • Dr. Robert Rodnitzky
  • Dr. Stephen Reich
  • Dr. Brad Racette
  • Dr. Eric Molho
  • Dr. Joseph Friedman
  • Dr. Vanessa Hinson
  • Dr. Sam Kabbani
  • Dr. Madhavi Thomas
  • Dr. Gordon Smith
  • Dr. Patrick Hogan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

1500U Myobloc

2500U Myobloc

3500U Myobloc

pooled placebo

Outcomes

Primary Outcome Measures

Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection
9 point scale, 0 = no drooling, 9 = severe drooling

Secondary Outcome Measures

Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection
9 point scale (0=no drooling, 9=severe drooling)
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"
Change in Unstimulated Salivary Flow Rate at Wk 12 Post-injection
saliva collected over 5 minutes and weighed to produce a grams/minute "rate"

Full Information

First Posted
August 10, 2007
Last Updated
April 29, 2019
Sponsor
Solstice Neurosciences
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1. Study Identification

Unique Protocol Identification Number
NCT00515437
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Solstice Neurosciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drooling
Keywords
Sialorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
1500U Myobloc
Arm Title
2
Arm Type
Experimental
Arm Description
2500U Myobloc
Arm Title
3
Arm Type
Experimental
Arm Description
3500U Myobloc
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
pooled placebo
Intervention Type
Biological
Intervention Name(s)
Botulinum Toxin Type B (Myobloc)
Intervention Type
Biological
Intervention Name(s)
Matched placebo to Myobloc
Primary Outcome Measure Information:
Title
Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection
Description
9 point scale, 0 = no drooling, 9 = severe drooling
Time Frame
baseline versus 4 weeks post-injection
Secondary Outcome Measure Information:
Title
Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection
Description
9 point scale (0=no drooling, 9=severe drooling)
Time Frame
baseline vs 12 weeks post injection
Title
Change in Unstimulated Salivary Flow Rate at Wk 4 Post-injection
Description
saliva is collected over 5 minutes and weighed to produce a grams/minute "rate"
Time Frame
baseline vs 4 weeks post-injection
Title
Change in Unstimulated Salivary Flow Rate at Wk 12 Post-injection
Description
saliva collected over 5 minutes and weighed to produce a grams/minute "rate"
Time Frame
baseline vs 12 weeks post-injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Pappert, MD
Organizational Affiliation
Solstice Neurosciences
Official's Role
Study Director
Facility Information:
Facility Name
Dr Virgilio Evidente
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Dr. Ronald Ziman
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Dr. James Sutton
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Dr. Olga Klepitskaya
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Dr. Fernando Pagan
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Dr Hubert Fernandez
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Dr. Alan Freeman
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Dr. Katie Kompoliti
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Dr. Robert Rodnitzky
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Dr. Stephen Reich
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Dr. Brad Racette
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dr. Eric Molho
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Dr. Joseph Friedman
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Dr. Vanessa Hinson
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Dr. Sam Kabbani
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Facility Name
Dr. Madhavi Thomas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Dr. Gordon Smith
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Dr. Patrick Hogan
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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