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

Korábbi kezelés

• The participant has previously been dosed with Lu AF28996.
• The participant has participated in a clinical trial <30 days prior to screening.
• The participant has taken any investigational medicinal product (IMP) <3 months or <5 half-lives, whichever is longer, prior to screening.

Más betegség

• 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).

Egyéb

• 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 a Montréal Cognitive Assessment (MoCA) score ≤24 (adjusted for education).
• 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

• 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.