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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00623363
First Posted: February 26, 2008
Last Update Posted: December 7, 2015
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.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

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 ]
  • pharmacokinetic data for investigational study drug [ Time Frame: 48 hours ]

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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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
Daiichi Sankyo, Inc.
  More Information

Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00623363     History of Changes
Other Study ID Numbers: ASBI-501
First Submitted: January 2, 2008
First Posted: February 26, 2008
Last Update Posted: December 7, 2015
Last Verified: November 2015

Keywords provided by Daiichi Sankyo, 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
Piclozotan
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs