NCT00623363

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_2

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 13, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2008

Completed
12.7 years until next milestone

Results Posted

Study results publicly available

March 11, 2021

Completed
Last Updated

March 11, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

January 2, 2008

Results QC Date

February 17, 2021

Last Update Submit

February 17, 2021

Conditions

Parkinson's Disease

Keywords

Parkinson's Diseasemotor complicationsdyskinesiaMotor complications associated with Parkinson's

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in the Percentage of "On" Time Without Dyskinesia Averaged Over Days 1 and 2 in Participants Treated With SUN N4057 and Those Treated With a Placebo

    Improvement in motor complications associated with Parkinson's disease are measured as "on" (good medication response); OR "on with dyskinesia" (good medication response, but with superimposed involuntary movements that interfere with activities), OR "off" (poor medication response).

    Baseline (Day-7) up to 2 days post-dose.

Secondary Outcomes (15)

  • Change From Baseline up to Day 2 in the Percentage of "on" Time Without Dyskinesia, as Assessed Over Hours 1 to 8 for Each Time Point in Participants Treated With SUN N4057 and Those Treated With a Placebo

    Baseline (Day -7), Day 1, and Day 2 post-dose.

  • Percentage of "on" Time With Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo

    Baseline (Day -7), Day 1, and Day 2 post-dose.

  • Percentage of "on" Time With Dyskinesia for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo

    Baseline (Day -7), Day 1, and Day 2 post-dose.

  • Percentage of "on" Time With or Without Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo

    Baseline (Day -7), Day 1 and Day 2 post-dose.

  • Percentage of "on" Time With or Without Dyskinesia for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo

    Baseline (Day -7), Day 1 and Day 2 post-dose.

  • +10 more secondary outcomes

Study Arms (2)

piclozotan

ACTIVE COMPARATOR

Participants will be randomized to receive two 12-hour intravenous (IV) infusions of piclozotan administered at a plasma level of 30 ng/mL over 2 inpatient days.

Drug: piclozotan

0.9 % sodium chloride (normal saline)

PLACEBO COMPARATOR

Participants will be randomized to receive two 12-hour intravenous (IV) infusions of 0.9 % sodium chloride (normal saline) administered at a plasma level of 30 ng/mL over 2 inpatient days.

Drug: 0.9% sodium chloride (normal saline)

Interventions

piclozotanDRUG

piclozotan, intravenous (IV) infusion

Also known as: SUN N4057
piclozotan
0.9% sodium chloride (normal saline)DRUG

0.9% sodium chloride (normal saline) intravenous (IV) infusion

0.9 % sodium chloride (normal saline)

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 Unified Parkinson's Disease Rating Scale (UPDRS) part III scores after dosing with regular Parkinson's disease (PD) medications
  • Mini-Mental State Examination (MMSE) score of 25 or higher

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

The Parkinson's and Movement Disorder Institute

Fountain Valley, California, 92708, United States

Location

University of South Florida, Parkinson's Disease and Movement Disorders Center

Tampa, Florida, 33606, United States

Location

Emory University--Wesley Woods Health Center

Atlanta, Georgia, 30329, United States

Location

UMDNJ-Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Suny Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Hospital Multimedica

Guatemala City, Guatemala

Location

Hospital Clinic of Neurology and Psychiatry Oradea

Oradea, Romania

Location

MeSH Terms

Conditions

Parkinson DiseaseDyskinesias

Interventions

PiclozotanSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Contact for Clinical Trial Information
Organization
Daiichi Sankyo
CTRinfo@dsi.com
908-992-6400

Study Officials

  • Global Clinical Leader

    Daiichi Sankyo

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2008

First Posted

February 26, 2008

Study Start

July 13, 2007

Primary Completion

July 17, 2008

Study Completion

July 17, 2008

Last Updated

March 11, 2021

Results First Posted

March 11, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
More information

Locations

RO(1)GU(1)US(5)