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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-13

Study Completion Date

2008-07-17

Brief Summary

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

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Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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piclozotan

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.

Group Type ACTIVE_COMPARATOR

piclozotan

Intervention Type DRUG

piclozotan, intravenous (IV) infusion

0.9 % sodium chloride (normal saline)

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.

Group Type PLACEBO_COMPARATOR

0.9% sodium chloride (normal saline)

Intervention Type DRUG

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

Interventions

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piclozotan

piclozotan, intravenous (IV) infusion

Intervention Type DRUG

0.9% sodium chloride (normal saline)

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

Intervention Type DRUG

Other Intervention Names

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SUN N4057

Eligibility Criteria

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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 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

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No