CompletedPhase 2

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

United States27 participantsStarted 2007-07-13

Plain-language summary

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

Who can participate

Age range40 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

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

Trial details

NCT IDNCT00623363

SponsorDaiichi Sankyo

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-07-17

Results submitted2021-02-17

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