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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:
Information provided by:
Solstice Neurosciences
ClinicalTrials.gov Identifier:
NCT00515437
First received: August 10, 2007
Last updated: June 30, 2009
Last verified: June 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-Injection [ Time Frame: baseline vs 12 weeks post injection ] [ Designated as safety issue: No ]
  • Change in Unstimulated Salivary Flow Rate at Wk 4 Post-Injection [ Time Frame: baseline vs 4 weeks post-injection ] [ Designated as safety issue: No ]
  • Change in Unstimulated Salivary Flow Rate at Wk 12 Post-Injection [ Time Frame: baseline vs 12 weeks post-injection ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515437

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

No publications provided

Responsible Party: Sharon Reinhard, Solstice Neurosciences, Inc.,
ClinicalTrials.gov Identifier: NCT00515437     History of Changes
Other Study ID Numbers: SN-SIAL-201
Study First Received: August 10, 2007
Results First Received: May 12, 2009
Last Updated: June 30, 2009
Health Authority: United States: Food and Drug Administration

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, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013