Interventional, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose trial of Lu AF28996 in adults with Parkinson’s disease experiencing motor fluctuations.

Condition studied

Parkinson’s disease

Investigational medicinal product(s)

Eligibility

Primary endpoint

Change From Baseline to Week 19 in Daily Good ON Time Based on the Participant’s Hauser Diary Entries

Endpoint detail

Change From Baseline to Week 19 in Daily OFF Time Based on Participant’s Hauser Diary Entries, Change From Baseline to Week 19 in Daily ON Time With Troublesome Dyskinesia Based on Participant’s Hauser Diary Entries in Participants Reporting ≥1 Hour of Daily ON Time With Troublesome Dyskinesia at Baseline, Change From Baseline to Week 19 in Participant’s Unified Dyskinesia Rating Scale (UDysRS) Total Score in Participants Reporting ≥1 Hour of Daily ON Time With Troublesome Dyskinesia at Baseline, Participant’s Achievement at Week 19 of a Reduction in Daily OFF Time, Defined as >1.5 Hour/Day Reduction, Participant’s Achievement at Week 19 of an Increase in Daily Good ON Time >1.5 Hour/Day, Participant’s Achievement at Week 19 of a Reduction in Both Daily ON Time With Troublesome Dyskinesia AND in OFF time in Participants Reporting ≥1 Hour of Daily ON Time With Troublesome Dyskinesia at Baseline, Change From Baseline to Week 19 in Clinical Global Impression – Severity of Illness (CGI-S) Score, Change From Baseline to Week 19 in Participant's Movement Disorder Society-Unified Parkinson’s Disease-Rating Scale (MDS-UPDRS) Part III Score, Change From Baseline to Week 19 in Participant's Movement Disorders Society Non-Motor Rating Scale (MDS-NMS) Domain Scores and Total Score, Change From Baseline to Week 19 in Participant's Parkinson’s Disease Sleep Scale Version 2 (PDSS-2) Total Score, Change From Baseline to Week 19 in Participant’s MDS-UPDRS Part IV (B) (Questions 4.1, 4.2, 4.3, 4.4 Item Scores), and Part IV Score, Change From Baseline to Week 19 in Participant's MDS-UPDRS Total Score, Change From Baseline to Week 19 in Participant's MDS-UPDRS Part I Score, Change From Baseline to Week 19 in Participant's MDS-UPDRS Part II Score, Change From Baseline to Week 19 in Participant's Parkinson’s Disease Questionnaire-39 (PDQ-39) Score, Change From Baseline to Week 19 in Participant's EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) Visual Analogue Scale Score, Change From Baseline to Week 19 in Daily Oral Levodopa (mg), Change From Baseline to Week 19 in Levodopa-equivalent Dose (LED), Change From Baseline to Week 19 in Total Levodopa-equivalent Daily Dose (LED), Patient Global Impression of Change (PGI-C) Score at Week 19, Plasma Concentrations of Lu AF28996 and Metabolites, Change From Baseline to Week 19 in Daily ON Time With Troublesome Dyskinesia Based on Participant's Hauser Daily Entries, Change From Baseline to Week 19 in Daily ON Time Without Troublesome Dyskinesia Based on Participant's Hauser Daily Entries, Change From Baseline to Week 19 in Daily ON Time With Non-troublesome Dyskinesia Based on Participant's Hauser Daily Entries, Change From Baseline to Week 19 in Participant's UDysRS Total Score and Combined Partial Scores of Part 1 + Part 2, Part 3 + Part 4, and Part 1 + Part 3 + Part 4, in Participants With UDysRS Total Score ≥20 at Baseline, Number of Participants With Achievement of a Reduction in Daily ON Time With Troublesome Dyskinesia at Week 19, Number of Participants With Achievement of No Worsening in Daily ON Time With Troublesome Dyskinesia at Week 19