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

Sponsored by:	Solstice Neurosciences
Information provided by:	Solstice Neurosciences
ClinicalTrials.gov Identifier:	NCT00515437

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: MYOBLOC	Phase I Phase II

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Solstice Neurosciences:

Primary Outcome Measures:

Safety & Tolerability Endpoints [ Time Frame: measured over 20 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Preliminary Efficacy scales [ Time Frame: measured over 20 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	July 2007
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1, 2, 3 and placebo: Experimental 3 dose groups and placebo	Biological: MYOBLOC botulinum toxin type B

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 80 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

Responsible Party:	Solstice Neurosciences, Inc., ( Sharon Reinhard )
Study ID Numbers:	SN-SIAL-201
Study First Received:	August 10, 2007
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00515437
Health Authority:	United States: Food and Drug Administration

Keywords provided by Solstice Neurosciences:

Sialorrhea

Study placed in the following topic categories:

Mouth Diseases
Sialorrhea
Ganglion Cysts
Basal Ganglia Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases

Botulinum Toxins
Parkinson Disease
Movement Disorders
Parkinsonian Disorders
Stomatognathic Diseases
Salivary Gland Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009