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

17 février 2021 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

27

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Guatemala
      • Guatemala, Guatemala
        • Hospital Multimedica
  • Roumanie
      • Oradea, Roumanie
        • Hospital Clinic of Neurology and Psychiatry Oradea
  • États-Unis
    • California
      • Fountain Valley, California, États-Unis, 92708
        • The Parkinson's and Movement Disorder Institute
    • Florida
      • Tampa, Florida, États-Unis, 33606
        • University of South Florida, Parkinson's Disease and Movement Disorders Center
    • Georgia
      • Atlanta, Georgia, États-Unis, 30329
        • Emory University--Wesley Woods Health Center
    • New Jersey
      • New Brunswick, New Jersey, États-Unis, 08901
        • UMDNJ-Robert Wood Johnson Medical School
    • New York
      • Brooklyn, New York, États-Unis, 11203
        • SUNY Downstate Medical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

40 ans à 85 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Médicament: piclozotan
piclozotan, intravenous (IV) infusion
Autres noms:
  • SUN N4057
Comparateur placebo: 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.
Médicament: 0.9% sodium chloride (normal saline)
0.9% sodium chloride (normal saline) intravenous (IV) infusion

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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
Délai: Baseline (Day-7) up to 2 days 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).
Baseline (Day-7) up to 2 days post-dose.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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
Délai: 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).
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
Délai: 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.
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
Délai: 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.
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
Délai: 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.
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
Délai: 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.
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
Délai: 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.
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
Délai: 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.
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
Délai: Baseline (Day -7), 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.
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
Délai: 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.
Day 1 and Day 2 post-dose.
Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057
Délai: 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.
The mean concentration of study drug, SUN N4057, in participant blood plasma samples drawn during infusions.
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
Délai: Baseline (Day 1 pre-dose) up to Hour 24, and Hour 48 post-dose.
Cmax is the observed maximum concentration of SUN N4057 in the participant blood plasma sample after drug administration.
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
Délai: Day 1 pre-dose (Hour 0) up to Hour 24, and Hour 48 post-dose.
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)
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
Délai: Day 1 at 1 hour, 6 hours, and12 hours; Day 2 at 25 hours, 30 hours, and 36 hours post-dose.
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)
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
Délai: 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.
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.
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
Délai: Baseline up to Day 16 post-dose, up to approximately a total 12 months.
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.
Baseline up to Day 16 post-dose, up to approximately a total 12 months.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Daiichi Sankyo, Inc.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

13 juillet 2007

Achèvement primaire (Réel)

17 juillet 2008

Achèvement de l'étude (Réel)

17 juillet 2008

Dates d'inscription aux études

Première soumission

2 janvier 2008

Première soumission répondant aux critères de contrôle qualité

19 février 2008

Première publication (Estimation)

26 février 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 mars 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 février 2021

Dernière vérification

1 février 2021

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • ASBI-501

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Oui

Description du régime IPD

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/

Délai de partage IPD

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.

Critères d'accès au partage IPD

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.

Type d'informations de prise en charge du partage d'IPD

  • Protocole d'étude
  • Plan d'analyse statistique (PAS)
  • Rapport d'étude clinique (CSR)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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