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

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ClinicalTrials.gov Identifier: NCT00515437
Recruitment Status : Completed
First Posted : August 13, 2007
Results First Posted : August 13, 2009
Last Update Posted : August 13, 2009
Sponsor:
Information provided by:
Solstice Neurosciences

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

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

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  (Clinical Trial)
Actual Enrollment : 54 participants
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
Study Start Date : July 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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

Secondary Outcome Measures :
  1. Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-Injection [ Time Frame: baseline vs 12 weeks post injection ]
  2. Change in Unstimulated Salivary Flow Rate at Wk 4 Post-Injection [ Time Frame: baseline vs 4 weeks post-injection ]
  3. Change in Unstimulated Salivary Flow Rate at Wk 12 Post-Injection [ Time Frame: baseline vs 12 weeks post-injection ]


Information from the National Library of Medicine

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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

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

Responsible Party: Sharon Reinhard, Solstice Neurosciences, Inc.,
ClinicalTrials.gov Identifier: NCT00515437     History of Changes
Other Study ID Numbers: SN-SIAL-201
First Posted: August 13, 2007    Key Record Dates
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
onabotulinumtoxinA
abobotulinumtoxinA
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