Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease
17 februari 2021 uppdaterad av: Daiichi Sankyo, Inc.
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
The purpose of this study is to obtain preliminary information on the effect of piclozotan on motor complications associated with Parkinson's Disease.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
27
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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California
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Fountain Valley, California, Förenta staterna, 92708
- The Parkinson's and Movement Disorder Institute
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Florida
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Tampa, Florida, Förenta staterna, 33606
- University of South Florida, Parkinson's Disease and Movement Disorders Center
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Georgia
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Atlanta, Georgia, Förenta staterna, 30329
- Emory University--Wesley Woods Health Center
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New Jersey
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New Brunswick, New Jersey, Förenta staterna, 08901
- UMDNJ-Robert Wood Johnson Medical School
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New York
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Brooklyn, New York, Förenta staterna, 11203
- SUNY Downstate Medical Center
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Guatemala, Guatemala
- Hospital Multimedica
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Oradea, Rumänien
- Hospital Clinic of Neurology and Psychiatry Oradea
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år till 85 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: piclozotan
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.
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piclozotan, intravenous (IV) infusion
Andra namn:
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Placebo-jämförare: 0.9 % sodium chloride (normal saline)
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.
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0.9% sodium chloride (normal saline) intravenous (IV) infusion
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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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
Tidsram: Baseline (Day-7) up to 2 days post-dose.
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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).
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Baseline (Day-7) up to 2 days post-dose.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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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
Tidsram: Baseline (Day -7), Day 1, and Day 2 post-dose.
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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).
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Baseline (Day -7), Day 1, and Day 2 post-dose.
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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
Tidsram: Baseline (Day -7), Day 1, and Day 2 post-dose.
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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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Baseline (Day -7), Day 1, and Day 2 post-dose.
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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
Tidsram: Baseline (Day -7), Day 1, and Day 2 post-dose.
|
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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Baseline (Day -7), Day 1, and Day 2 post-dose.
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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
Tidsram: Baseline (Day -7), Day 1 and Day 2 post-dose.
|
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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Baseline (Day -7), Day 1 and Day 2 post-dose.
|
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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
Tidsram: Baseline (Day -7), Day 1 and Day 2 post-dose.
|
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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Baseline (Day -7), Day 1 and Day 2 post-dose.
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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
Tidsram: Baseline (Day -7), Day 1, and Day 2 post-dose.
|
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.
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Baseline (Day -7), Day 1, and Day 2 post-dose.
|
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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
Tidsram: Baseline (Day -7), Day 1, and Day 2 post-dose.
|
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.
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Baseline (Day -7), Day 1, and Day 2 post-dose.
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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
Tidsram: Baseline (Day -7), Day 1, and Day 2 post-dose.
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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.
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Baseline (Day -7), Day 1, and Day 2 post-dose.
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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
Tidsram: Day 1 and Day 2 post-dose.
|
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.
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Day 1 and Day 2 post-dose.
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Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057
Tidsram: 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.
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The mean concentration of study drug, SUN N4057, in participant blood plasma samples drawn during infusions.
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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.
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Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Maximum Concentration (Cmax) Following Treatment With SUN N4057
Tidsram: Baseline (Day 1 pre-dose) up to Hour 24, and Hour 48 post-dose.
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Cmax is the observed maximum concentration of SUN N4057 in the participant blood plasma sample after drug administration.
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Baseline (Day 1 pre-dose) up to Hour 24, and Hour 48 post-dose.
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Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Minimum Concentration (Cmin) Following Treatment With SUN N4057
Tidsram: Day 1 pre-dose (Hour 0) up to Hour 24, and Hour 48 post-dose.
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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)
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Day 1 pre-dose (Hour 0) up to Hour 24, and Hour 48 post-dose.
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Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Mean Concentration (Caverage) Following Treatment With SUN N4057
Tidsram: Day 1 at 1 hour, 6 hours, and12 hours; Day 2 at 25 hours, 30 hours, and 36 hours post-dose.
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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)
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Day 1 at 1 hour, 6 hours, and12 hours; Day 2 at 25 hours, 30 hours, and 36 hours post-dose.
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Mean SUN N4057 Pharmacokinetic Parameter of Area Under the Drug Concentration vs Time Curve (AUCt) Following Treatment With SUN N4057
Tidsram: 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.
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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.
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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.
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Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Tidsram: Baseline up to Day 16 post-dose, up to approximately a total 12 months.
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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.
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Baseline up to Day 16 post-dose, up to approximately a total 12 months.
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
13 juli 2007
Primärt slutförande (Faktisk)
17 juli 2008
Avslutad studie (Faktisk)
17 juli 2008
Studieregistreringsdatum
Först inskickad
2 januari 2008
Först inskickad som uppfyllde QC-kriterierna
19 februari 2008
Första postat (Uppskatta)
26 februari 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 mars 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 februari 2021
Senast verifierad
1 februari 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Parkinsons sjukdom
- Basala ganglia sjukdomar
- Rörelsestörningar
- Synukleinopatier
- Neurodegenerativa sjukdomar
- Parkinsons sjukdom
- Läkemedels fysiologiska effekter
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Serotoninmedel
- Serotonin 5-HT1-receptoragonister
- Serotoninreceptoragonister
- Piclozotan
Andra studie-ID-nummer
- ASBI-501
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Ja
IPD-planbeskrivning
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/.
In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants.
Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Tidsram för IPD-delning
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Kriterier för IPD Sharing Access
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research.
This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD-delning som stöder informationstyp
- Studieprotokoll
- Statistisk analysplan (SAP)
- Klinisk studierapport (CSR)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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