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

This study has been completed.
Information provided by (Responsible Party):
Daiichi Sankyo Inc. Identifier:
First received: January 2, 2008
Last updated: November 6, 2015
Last verified: November 2015
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:

Further study details as provided by Daiichi Sankyo 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
Other Name: SUN N4057
Placebo Comparator: 0.9 % sodium chloride (normal saline) Drug: 0.9% sodium chloride (normal saline)
0.9% sodium chloride (normal saline)


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00623363

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
Hospital Multimedica
Guatemala, Guatemala
Hospital Clinic of Neurology and Psychiatry Oradea
Oradea, Romania
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided

Responsible Party: Daiichi Sankyo Inc. Identifier: NCT00623363     History of Changes
Other Study ID Numbers: ASBI-501 
Study First Received: January 2, 2008
Last Updated: November 6, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
Parkinson's Disease
motor complications
Motor complications associated with Parkinson's

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders processed this record on February 10, 2016