Universitat Autònoma de Barcelona
Sant Pau Hospital
Prof. Dr. Jaime Kulisevsky is a Movement Disorders specialist, Director of the Movement Disorders Unit at the Neurology Department of Sant Pau Hospital, Full Professor of Neurology and Associate-Dean of the Faculty of Medicine at Universitat Autònoma de Barcelona, Spain, where he also coordinates the Master in Neuropsychological Diagnosis and Rehabilitation. His main research and clinical interest focuses on cognitive and behavioral consequences related to Basal Ganglia and Movement Disorders and on the pharmacological management of movement disorders such as Parkinson and Huntington’s disease, on which he published numerous papers. The research group lead by prof. Kulisevsky, has a solid trajectory on the development and validation of specific instruments for the cognitive and functional assessment of Parkinson’s disease (PD) and Huntington’s disease (HD). Prof. Kulisevsky is the leading author of more than 200 papers published in peer-reviewed journals related to PD and HD. Prof. Kulisevsky is also the Spanish coordinator of the European Huntington Disease Network, the current PI in Spain for the Enroll-HD study and the PI of the Parkinson’s disease (PD) Area of the Spanish Biomedical Network Research Centre for Neurodegenerative Diseases (CIBERNED-Instituto de Salud Carlos III). Among other national and international societies, he is an active member of the International Movement Disorders Society, where he was actively involved in the development of instruments for cognitive assessment in Parkinson’s disease and for the definition of the diagnostic criteria for mild cognitive impairment in Parkinson’s disease. He is also a Fellow of the European Academy of Neurology and the Spanish Neurological Society, member of the Executive Committee of the European Section of the Movement Disorders Society and of the Executive Committee of the European Huntington’s Disease Network (EHDN), and coordinator of the Cognitive Phenotype Working Group of the EHDN.

Presenter of 2 Presentations

Discussants

Session Type
FORUM
Date
Thu, 17.03.2022
Session Time
03:50 PM - 04:50 PM
Room
ONSITE PLENARY: 115-117
Lecture Time
03:50 PM - 04:50 PM

EFFECT OF ISTRADEFYLLINE DOSAGE ON UNIFIED PARKISONS’ DISEASE RATING SCALE (UPDRS) III-ON SCORES: RESULTS FROM FOUR RANDOMIZED CLINICAL TRIALS

Session Type
SYMPOSIUM
Date
Sun, 20.03.2022
Session Time
11:35 AM - 01:20 PM
Room
ONSITE: 114
Lecture Time
12:50 PM - 01:05 PM

Abstract

Aims

Istradefylline, a selective adenosine A2A receptor antagonist, is indicated in the US and Japan as adjunctive treatment to levodopa-containing medication in adults with Parkinson’s disease (PD) experiencing OFF-time. This four-trial analysis evaluated impact of istradefylline dosage on UPDRS-III-ON score.

Methods

Data from four randomized, phase 2b/3 trials (6002-US-018, 6002-009, 6002-0608, and 6002-014) were analyzed to determine the difference in impact of 20 vs 40mg/day istradefylline on UPDRS-III-ON scores in patients with PD experiencing OFF-time. For each study, difference in least-squares (LS) mean change from baseline in UPDRS-III-ON scores for the two dosages was assessed by mixed-model repeated-measures analyses; results were combined using a random-effect meta-analysis.

Results

The LS mean change from baseline to week 12 in UPDRS-III-ON score was greater with istradefylline than placebo; in three studies, this effect was greater at the 40mg/day dose vs 20mg/day (Figure). In the random-effect meta-analysis, there was a significant difference in LS mean change from baseline between 20 and 40mg/day treatment arms (-0.80 [95%CI, -1.55, -0.04], nominal p=0.038). The rates of treatment-emergent adverse events (TEAEs) from each of the four studies were comparable between the 20 (59-82%) and 40mg/day (59-84%) dosages; the most common TEAE was dyskinesia in three studies (20mg/day, 11-17% vs 40mg/day, 12-26%) and nasopharyngitis in one (6% vs 9%). Impact of baseline UPDRS-III-ON score on improvements at both dosages will be presented.

figure.jpg

Conclusions

Regarding motor improvement, these data suggest that 40mg/day istradefylline has greater benefit than 20mg/day. Safety was comparable between the two istradefylline treatment groups.

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