A Trial Investigating Lu AF28996 in Adults With Parkinson's Disease Who Have Motor Fluctuations

Официальное название

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose Trial of Lu AF28996 in Adults With Parkinson's Disease Experiencing Motor Fluctuations

Обзор

This trial will evaluate the effects of Lu AF28996 in adults with Parkinson's disease (PD) experiencing motor fluctuations despite optimized non-invasive symptomatic treatment. These are individuals with PD who take medications to control movement symptoms, such as slowness, stiffness, and tremor, but still experience periods of time when their medication does not adequately control their motor symptoms. Some may also experience dyskinesia (other type of involuntary movements) as a side effect of their PD medications. The main goal of the trial is to learn whether adding Lu AF28996 to participants' optimized PD medications will help extending the time they spend with their movement symptoms being well-controlled and without bothersome dyskinesia.

Вмешательства

• Препарат Lu AF28996
  Lu AF28996 will be administered orally per schedule specified in the arm description.
• Препарат Placebo
  Placebo matching to Lu AF28996 will be administered orally per schedule specified in the arm description.

Первичные конечные точки

• Change From Baseline to Week 19 in Daily Good ON Time Based on the Participant's Hauser Diary Entries [Срок оценки: Baseline, Week 19]

Вторичные конечные точки (12)

• Change From Baseline to Week 19 in Daily OFF Time Based on Participant's Hauser Diary Entries [Срок оценки: Baseline, Week 19]
• 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 [Срок оценки: Baseline, Week 19]
• 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 [Срок оценки: Baseline, Week 19]
• Participant's Achievement at Week 19 of a Reduction in Daily OFF Time, Defined as >1.5 Hour/Day Reduction [Срок оценки: Week 19]
• Participant's Achievement at Week 19 of an Increase in Daily Good ON Time >1.5 Hour/Day [Срок оценки: Week 19]
• 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 [Срок оценки: Week 19]
• Change From Baseline to Week 19 in Clinical Global Impression - Severity of Illness (CGI-S) Score [Срок оценки: Baseline, Week 19]
• Change From Baseline to Week 19 in Participant's Movement Disorder Society-Unified Parkinson's Disease-Rating Scale (MDS-UPDRS) Part III Score [Срок оценки: Baseline, Week 19]
• Change From Baseline to Week 19 in Participant's Movement Disorders Society Non-Motor Rating Scale (MDS-NMS) Domain Scores and Total Score [Срок оценки: Baseline, Week 19]
• Change From Baseline to Week 19 in Participant's Parkinson's Disease Sleep Scale Version 2 (PDSS-2) Total Score [Срок оценки: Baseline, Week 19]
• 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 [Срок оценки: Baseline, Week 19]
• Change From Baseline to Week 19 in Participant's MDS-UPDRS Total Score [Срок оценки: Baseline, Week 19]

Критерии участия

Критерии включения

• The participant was diagnosed with PD ≥3 years ago, with the diagnosis being established after the age of 30 years and consistent with the Movement Disorders Society (MDS) Clinical Diagnostic Criteria for "clinically established" or "clinically probable" PD.
• The participant has a modified Hoehn and Yahr scale (mH\&Y) stage ≤3 in the ON state and ≥2 and ≤4 in the OFF state.
• The participant reports well recognizable, consistent motor fluctuations causing significant disability per investigator's judgement over a period of ≥3 months prior to screening.
• The participants report motor fluctuations each day as measured by OFF-time during awake hours.

Критерии исключения

• The participant has previously been dosed with Lu AF28996.
• The participant has participated in a clinical trial <30 days prior to screening.
• The participant is pregnant, breastfeeding, intends to become pregnant, or is of child-bearing potential and not willing to use adequate contraceptive methods.
• The participant has taken any investigational medicinal product (IMP) <3 months or <5 half-lives, whichever is longer, prior to screening.
• The participant has a Montréal Cognitive Assessment (MoCA) score ≤24 (adjusted for education).
• The participant has an atypical, secondary, or drug-induced Parkinsonism (for example, metoclopramide, flunarizine), metabolic identified neurogenetic disorders (for example, Wilson's disease), encephalitis, or Parkinson Plus syndromes or other forms of atypical Parkinsonian syndromes (for example, progressive supranuclear palsy and multiple system atrophy).
• The participant has severe, pervasive, disabling dyskinesia which, in the setting of the present trial, may interfere with his/her safe participation in the trial (for example, threat to falling, aspiration, etc.) as judged by the investigator.
• The participant has unpredictable motor fluctuations as evidenced by an MDS-UPDRS Part IV Item 4.5 score ≥3 at screening and/or experiences wide, unpredictable fluctuations of PD symptoms per investigator's clinical judgement.

Note: Other protocol defined inclusion and exclusion criteria may apply

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07514858 · 20309A

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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