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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00515437
First Posted: August 13, 2007
Last Update Posted: August 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Solstice Neurosciences
  Purpose
To determine safety, tolerability and preliminary efficacy of intraglandular injections of MYOBLOC for the treatment of sialorrhea in Parkinsons' Disease patients

Condition Intervention Phase
Drooling Biological: Botulinum Toxin Type B (Myobloc) Biological: Matched placebo to Myobloc Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Solstice Neurosciences:

Primary Outcome Measures:
  • Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-Injection [ Time Frame: baseline versus 4 weeks post-injection ]

Secondary Outcome Measures:
  • Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-Injection [ Time Frame: 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 ]
  • Change in Unstimulated Salivary Flow Rate at Wk 12 Post-Injection [ Time Frame: baseline vs 12 weeks post-injection ]

Enrollment: 54
Study Start Date: July 2007
Study Completion Date: September 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00515437


  Show 18 Study Locations
Sponsors and Collaborators
Solstice Neurosciences
Investigators
Study Director: Eric Pappert, MD Solstice Neurosciences
  More Information

Responsible Party: Sharon Reinhard, Solstice Neurosciences, Inc.,
ClinicalTrials.gov Identifier: NCT00515437     History of Changes
Other Study ID Numbers: SN-SIAL-201
First Submitted: August 10, 2007
First Posted: August 13, 2007
Results First Submitted: May 12, 2009
Results First Posted: August 13, 2009
Last Update Posted: August 13, 2009
Last Verified: June 2009

Keywords provided by Solstice Neurosciences:
Sialorrhea

Additional relevant MeSH terms:
Parkinson Disease
Sialorrhea
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
onabotulinumtoxinA
rimabotulinumtoxinB
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Anti-Dyskinesia Agents