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

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Parkinson's Disease

Treatments: Drug: 0.9% sodium chloride (normal saline); Drug: piclozotan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00623363

ASBI-501

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups, including a placebo group

piclozotan

Active Comparator group

Description:

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.

Treatment:

Drug: piclozotan

0.9 % sodium chloride (normal saline)

Placebo Comparator group

Description:

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.

Treatment:

Drug: 0.9% sodium chloride (normal saline)