Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease - Full Text View

Sponsored by:	Asubio Pharmaceuticals, Inc.
Information provided by:	Asubio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00623363

Purpose

The purpose of this study is to obtain preliminary information on the effect of piclozotan on motor complications associated with Parkinson's Disease.

Condition	Intervention	Phase
Parkinson's Disease	Drug: piclozotan Drug: 0.9% sodium chloride (normal saline)	Phase II

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

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Sodium chloride Chlorides Piclozotan

U.S. FDA Resources

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

Further study details as provided by Asubio Pharmaceuticals, Inc.:

Primary Outcome Measures:

"on" time without dyskinesia [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability data as measured by adverse events, electrocardiograms, physical exams, clinical laboratories tests, and vital signs [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
pharmacokinetic data for investigational study drug [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	16
Study Start Date:	April 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
piclozotan: Active Comparator	Drug: piclozotan piclozotan, IV
0.9 % sodium chloride (normal saline): Placebo Comparator	Drug: 0.9% sodium chloride (normal saline) 0.9% sodium chloride (normal saline)

Eligibility

Ages Eligible for Study:	40 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

Idiopathic Parkinson's disease for at least 5 years
Presence of motor fluctuations and dyskinesia
Stable regimen of levodopa/carbidopa for 30 days
At least 25% response/improvement in UPDRS part III scores after dosing with regular PD medications
MMSE score of 25 or higher

Main Exclusion Criteria:

Atypical or secondary parkinsonism.
Prior use of neuroleptic agents.
History of intracranial procedures for PD.
Active psychosis.
History of drug or alcohol abuse in past 12 months.
Cardiac conduction system abnormality.
Predisposing medical condition that causes nausea or vomiting or routine use of an anti-emetic.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623363

Locations

United States, California
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States, 92708
United States, Florida
University of South Florida, Parkinson's Disease and Movement Disorders Center
Tampa, Florida, United States, 33606
United States, Georgia
Emory University--Wesley Woods Health Center
Atlanta, Georgia, United States, 30329
United States, New Jersey
UMDNJ-Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
United States, New York
Suny Downstate Medical Center
Brooklyn, New York, United States, 11203

Sponsors and Collaborators

Asubio Pharmaceuticals, Inc.

More Information

Responsible Party:	Asubio Pharmaceuticals, Inc ( Joseph Gertner, MB, BChir, MRCP )
Study ID Numbers:	ASBI-501
Study First Received:	January 2, 2008
Last Updated:	July 10, 2008
ClinicalTrials.gov Identifier:	NCT00623363
Health Authority:	United States: Food and Drug Administration

Keywords provided by Asubio Pharmaceuticals, Inc.:

Parkinson's Disease
motor complications
dyskinesia
Motor complications associated with Parkinson's

Study placed in the following topic categories:

Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
Central Nervous System Diseases

Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
Dyskinesias

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009