117
Participants
Start Date
October 23, 2020
Primary Completion Date
April 23, 2024
Study Completion Date
June 17, 2024
Active drug: pimavanserin 17mg (2 strength tablets)
Pimavanserin 17mg (2 strength tablets) will be taken orally daily from day 1 to Visit 4 (Week 8)
Placebo: 2 tablets containing same excipients except active compound
Placebo (2 strength tablets) will be taken orally daily from day 1 to Visit 4 (Week 8)
Assessment of severity of ICD (impulse control disorders)
Questionnaire for impulsive-compulsive disorders in Parkinson's disease rating scale (QUIP-RS) will be administrated at day 0, day 28 (Week 4) and day 56 (Week 8)
Assessment of motor and non-motors symptoms of PD Evaluation of hyper- and hypodopaminergic behaviors
Hyper- and hypodopaminergic behaviors (Ardouin's scale); Movement disorders society sponsored unified Parkinson's disease rating scale (MDS-UPDR), and daytime and night time sleep by scale for outcomes in Parkinson's disease SLEEP (SCOPA-SLEEP, ISI, PDSS-2) will be administrated at day 0, day 28 (Week 4) and day 56 (Week 8)
Assessment of quality of life
Parkinson's Disease questionnaire (PDQ-39) will be administrated at day 0, day 28 (Week 4) and day 56 (Week 8)
Assessment of depression
Montgomery-Åsberg Depression Rating Scale (MADRS) will be administrated at day 0 and day 56 (week 8)
Assessment of cognition
Cognitive state of patients by Montreal Cognitive Assessment (MOCA) will be assessed at day 0.
Assessment of severity of Parkinson Disease
Clinical Global Impression Severity scale (CGIS) will be administrated at day 0 , day 7, day 14, day 28, day 42 and day 56 (week 8) and day 112 (Week 16)
Blood analysis
Blood sample will be collected for analyse of safety (blood count/liver and kidney functions, electrolytes) at day 0 and day 56
Cardiac monitoring
Electrocardiogram will be realized at day 0, 28 and 56.
SERVICE DE NEUROLOGIE, Unité Mouvement Anormaux/Centre expert Parkinson, Hopital de la Timone, Marseille
SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CIC, CHU de Toulouse, Hopital Pierre-Paul Riquet, Toulouse
SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CHU de Rennes, Hopital Pontchaillou, Rennes
SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CHU de Grenoble Alpes, Grenoble
SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CIC, CHU de Nantes, Hopital Laennec, Nantes
SERVICE DE NEUROLOGIE, CHU de REIMS, Reims
SERVICE DE NEUROLOGIE, Unité Mouvement Anormaux/Centre expert Parkinson, CHU de Lille, Hopital Roger Salengro, Lille
SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson CHU Clermont-Ferrand, Hopital Gabriel Montpied, Clermont-Ferrand
SERVICE DE NEUROLOGIE Unité de Mouvements Anormaux/Centre expert Parkinson, CHU de Strasbourg, Hopital de Hautepierre, Strasbourg
SERVICE DE NEUROLOGIE C, Unité mouvement anormaux/Centre expert Parkinson, CHU de Lyon, Hopital neurologique Pierre Wertheimer, Bron
SERVICE DE NEUROLOGIE Centre Expert Parkinson Hopital de la Pitié-Salpêtrière, Paris
SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CHU de Rouen, Hopital Charles Nicolle, Rouen
Centre d'Inverstigation Clinique, CHU de Poitiers, Poitiers
SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CHU de Limoges, Limoges
SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, Hopital Henri Mondor, Créteil
Service de Neurologie and CIC -CHU Besançon, Besançon
Collaborators (2)
NS-PARK
UNKNOWN
EUCLID Clinical Trial Platform
OTHER
F-CRIN
UNKNOWN
ACADIA Pharmaceuticals Inc.
INDUSTRY
University Hospital, Strasbourg, France
OTHER