Clinical trial NCT00623363: Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease
Official title: A Double-Blind, Placebo-Controlled, Preliminary Study of the Efficacy, Safety, and Tolerability of Intravenous SUN N4057 in Patients With Motor Complications Associated With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
motor complications
dyskinesia
Motor complications associated with Parkinson's
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2008-02-26
Enrollment: 27
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: 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
timeFrame: Baseline (Day -7), Day 1, and Day 2 post-dose.
measure: 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
timeFrame: Baseline (Day -7), Day 1, and Day 2 post-dose.
measure: 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
timeFrame: Baseline (Day -7), Day 1, and Day 2 post-dose.
measure: 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
timeFrame: Baseline (Day -7), Day 1 and Day 2 post-dose.
measure: 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
timeFrame: Baseline (Day -7), Day 1 and Day 2 post-dose.
measure: Percentage of "Off" Time at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo
timeFrame: Baseline (Day -7), Day 1, and Day 2 post-dose.
measure: Percentage of "Off" Time 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
timeFrame: Baseline (Day -7), Day 1, and Day 2 post-dose.
measure: Change From Baseline up to Day 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo
timeFrame: Baseline (Day -7), Day 1, and Day 2 post-dose.
measure: Average of Days 1 and 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo
timeFrame: Day 1 and Day 2 post-dose.
measure: Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057
timeFrame: Day 1 pre-dose (Hour 0), 1 hour, 6 hours, 12 hours; Day 2 pre-dose (Hour 24), 1 hour (Hour 25), 6 hours (Hour 30), 12 hours (Hour 36), and Day 3 Hour 0 (Hour 48) post-dose.
measure: Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Maximum Concentration (Cmax) Following Treatment With SUN N4057
timeFrame: Baseline (Day 1 pre-dose) up to Hour 24, and Hour 48 post-dose.
measure: Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Minimum Concentration (Cmin) Following Treatment With SUN N4057
timeFrame: Day 1 pre-dose (Hour 0) up to Hour 24, and Hour 48 post-dose.
measure: Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Mean Concentration (Caverage) Following Treatment With SUN N4057
timeFrame: Day 1 at 1 hour, 6 hours, and12 hours; Day 2 at 25 hours, 30 hours, and 36 hours post-dose.
measure: Mean SUN N4057 Pharmacokinetic Parameter of Area Under the Drug Concentration vs Time Curve (AUCt) Following Treatment With SUN N4057
timeFrame: Baseline (Day 1 pre-dose) up to Hour 0, Hour 1, Hour 6, Hour 12, Hour 24, Hour 25, Hour 30, Hour 36, and Hour 48 post-dose.
measure: Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
timeFrame: Baseline up to Day 16 post-dose, up to approximately a total 12 months.
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: The Parkinson's and Movement Disorder Institute
state: California
city: Tampa
country: United States
facility: University of South Florida, Parkinson's Disease and Movement Disorders Center
state: Florida
city: Atlanta
country: United States
facility: Emory University--Wesley Woods Health Center
state: Georgia
city: New Brunswick
country: United States
facility: UMDNJ-Robert Wood Johnson Medical School
state: New Jersey
city: Brooklyn
country: United States
facility: Suny Downstate Medical Center
state: New York
city: Guatemala
country: Guatemala
facility: Hospital Multimedica
city: Oradea
country: Romania
facility: Hospital Clinic of Neurology and Psychiatry Oradea
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: