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Trial record 1 of 2 for:    Piclozotan
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Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00623363
Recruitment Status : Completed
First Posted : February 26, 2008
Last Update Posted : December 7, 2015
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

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

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: piclozotan Drug: 0.9% sodium chloride (normal saline) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. "on" time without dyskinesia [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Safety and tolerability data as measured by adverse events, electrocardiograms, physical exams, clinical laboratories tests, and vital signs [ Time Frame: 48 hours ]
  2. pharmacokinetic data for investigational study drug [ Time Frame: 48 hours ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00623363

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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.

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Responsible Party: Daiichi Sankyo, Inc. Identifier: NCT00623363    
Other Study ID Numbers: ASBI-501
First Posted: February 26, 2008    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: November 2015
Keywords provided by Daiichi Sankyo, Inc.:
Parkinson's Disease
motor complications
Motor complications associated with Parkinson's
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs