The purpose of this study is to obtain preliminary information on the effect of piclozotan on motor complications associated with Parkinson's Disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
27
piclozotan, intravenous (IV) infusion
0.9% sodium chloride (normal saline) intravenous (IV) infusion
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States
University of South Florida, Parkinson's Disease and Movement Disorders Center
Tampa, Florida, United States
Emory University--Wesley Woods Health Center
Atlanta, Georgia, United States
UMDNJ-Robert Wood Johnson Medical School
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).
Time frame: Baseline (Day-7) up to 2 days post-dose.
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
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).
Time frame: 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
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). Negative values indicate a decrease in "on" time from baseline to measured time point.
Time frame: 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
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). Negative values indicate a decrease in "on" time from baseline to measured time point.
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New Brunswick, New Jersey, United States
Suny Downstate Medical Center
Brooklyn, New York, United States
Hospital Multimedica
Guatemala City, Guatemala
Hospital Clinic of Neurology and Psychiatry Oradea
Oradea, Romania
Time frame: 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
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). Negative values indicate a decrease in "on" time from baseline to measured time point.
Time frame: 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
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). Negative values indicate a decrease in "on" time from baseline to measured time point.
Time frame: Baseline (Day -7), Day 1 and Day 2 post-dose.
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
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). Negative values indicate a decrease in "off" time from baseline to measured time point.
Time frame: Baseline (Day -7), Day 1, and Day 2 post-dose.
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
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). Negative values indicate a decrease in "off" time from baseline to measured time point.
Time frame: Baseline (Day -7), Day 1, and Day 2 post-dose.
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
The Abnormal Involuntary Movement Scale (AIMS) is an assessment of dyskinesia in patients with movement disorders. The AIMS was originally developed to assess neuroleptic-induced extrapyramidal symptoms but has also been applied to the assessment of dyskinesia in patients with Parkinson's disease. AIMS questions 1 to 7 rate the degree of dyskinesia on a 0 to 4 scale in the extremities, trunk, and face, where 0 is no dyskinesia (better outcome) and 4 is severe dyskinesia (worse outcome). The total score range is 0 (better outcome) to 28 (worse outcome). Higher scores indicate a worse outcome.
Time frame: Baseline (Day -7), Day 1, and Day 2 post-dose.
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
The Abnormal Involuntary Movement Scale (AIMS) is an assessment of dyskinesia in patients with movement disorders. The AIMS was originally developed to assess neuroleptic-induced extrapyramidal symptoms but has also been applied to the assessment of dyskinesia in patients with Parkinson's disease. AIMS questions 1 to 7 rate the degree of dyskinesia on a 0 to 4 scale in the extremities, trunk, and face, where 0 is no dyskinesia (better outcome) and 4 is severe dyskinesia (worse outcome). The total score range is 0 (better outcome) to 28 (worse outcome). Higher scores indicate a worse outcome.
Time frame: Day 1 and Day 2 post-dose.
Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057
The mean concentration of study drug, SUN N4057, in participant blood plasma samples drawn during infusions.
Time frame: 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.
Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Maximum Concentration (Cmax) Following Treatment With SUN N4057
Cmax is the observed maximum concentration of SUN N4057 in the participant blood plasma sample after drug administration.
Time frame: Baseline (Day 1 pre-dose) up to Hour 24, and Hour 48 post-dose.
Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Minimum Concentration (Cmin) Following Treatment With SUN N4057
Cmin is the observed minimum concentration of SUN N4057 in the participant blood plasma sample after drug administration. Average of C24 and C48 \[ie, 24 hours after the initiation of infusion on Days 1 and 2. Cmin = average of (C24 and C48)
Time frame: Day 1 pre-dose (Hour 0) up to Hour 24, and Hour 48 post-dose.
Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Mean Concentration (Caverage) Following Treatment With SUN N4057
Caverage is the mean concentration of SUN N4057 in the participant blood plasma sample obtained from the observed concentrations during the 2-day drug infusions (average of C1, C6, C12, C25, C30, and C36 \[ie, Hours 1, 6, 12, 25, 30, and 36 after the initiation of infusion on Day 1\]). Caverage = average of (C1, C6, C12, C25, C30, and C36)
Time frame: Day 1 at 1 hour, 6 hours, and12 hours; Day 2 at 25 hours, 30 hours, and 36 hours post-dose.
Mean SUN N4057 Pharmacokinetic Parameter of Area Under the Drug Concentration vs Time Curve (AUCt) Following Treatment With SUN N4057
AUCt is defined as the area under the drug concentration vs time curve from zero up to the last sampling point with a quantifiable drug concentration which is above the lower limit of quantification.
Time frame: 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.
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
A treatment-emergent adverse event (TEAE) was defined as an Adverse Event (AE) that was new in onset or aggravated in severity or frequency following administration of the investigational agent. This included any change from the screening physical examination findings or results of diagnostic procedures (eg, laboratory test, ECG) that were clinically significant, eg, required diagnostic or therapeutic intervention beyond confirmation alone.
Time frame: Baseline up to Day 16 post-dose, up to approximately a total 12 months.