Text Size

Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by:
Asubio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00623363
First received: January 2, 2008
Last updated: April 4, 2011
Last verified: April 2011
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 27
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
Active Comparator: piclozotan Drug: piclozotan
piclozotan, IV
Placebo Comparator: 0.9 % sodium chloride (normal saline) 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
Guatemala
Hospital Multimedica
Guatemala, Guatemala
Romania
Hospital Clinic of Neurology and Psychiatry Oradea
Oradea, Romania
Sponsors and Collaborators
Asubio Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Joseph Gertner, MB, BChir, MRCP, Asubio Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00623363     History of Changes
Other Study ID Numbers: ASBI-501
Study First Received: January 2, 2008
Last Updated: April 4, 2011
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

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on June 17, 2013