Phase 2
Completed N=27
Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease
Source: ClinicalTrials.gov NCT00623363 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: 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 — 12.50; 18.75; 17.86; 36.11 percentage of on time — p=0.503
Summary
The purpose of this study is to obtain preliminary information on the effect of piclozotan on motor complications associated with Parkinson's Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
12.50; 18.75; 17.86; 36.11; 5.36; 17.36 | 0.503 |
| SECONDARY 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 |
12.50; 18.75; 23.21; 31.25; 10.71; 12.50 | — |
| SECONDARY 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 |
78.57; 60.42; 55.36; 48.61; -23.21; -11.81 | — |
| SECONDARY 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 |
59.82; 48.96; -18.75; -11.46 | — |
| SECONDARY 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 |
91.07; 79.17; 78.57; 79.86; -12.50; 0.69 | — |
| SECONDARY 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 |
77.68; 85.07; -13.39; 5.90 | — |
| SECONDARY 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 |
8.93; 20.83; 21.43; 20.14; 12.50; -0.69 | — |
| SECONDARY 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 |
22.32; 14.93; 13.39; -5.90 | — |
| SECONDARY 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 |
5.80; 4.31; 3.11; 2.60; -2.70; -1.70 | — |
| SECONDARY 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 |
3.04; 2.63; -2.76; -1.67 | — |
| SECONDARY Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057 |
0.00; 33.40; 28.34; 32.46; 11.26; 31.91 | — |
| SECONDARY Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Maximum Concentration (Cmax) Following Treatment With SUN N4057 |
46.95 | — |
| SECONDARY Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Minimum Concentration (Cmin) Following Treatment With SUN N4057 |
11.95 | — |
| SECONDARY Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Mean Concentration (Caverage) Following Treatment With SUN N4057 |
31.91 | — |
| SECONDARY Mean SUN N4057 Pharmacokinetic Parameter of Area Under the Drug Concentration vs Time Curve (AUCt) Following Treatment With SUN N4057 |
1271.20 | — |
| SECONDARY Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo |
6; 17; 2; 12; 0; 8 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00623363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.