Lu AF28996 in Participants With Parkinson's Disease (PD)

• Status: Recruiting
• Trial end date: 2022-07-22
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the safety of Lu AF28996, how well it is tolerated and what the body does to the drug in participants with Parkinson's disease.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S

Criteria

Inclusion Criteria:

• Men or women diagnosed with idiopathic PD (consistent with the UK PD Society Brain Bank Criteria for the Diagnosis of PD), Modified Hoehn and Yahr Score ≤4 in the 'OFF' state and ≤3 in 'ON' state and a Mini Mental State Examination Score >25.

• Participants must currently have a good response to levodopa, and has been receiving a stable dose of levodopa (>3 doses per day of standard levodopa or >3 doses per day of carbidopa and levodopa, or benserazide and levodopa, Extended-Release Capsules) for at least 4 weeks prior to screening.

• Participants must experience recognizable and predictable motor fluctuations (with at least 1.5 hours of OFF-periods in the awake time, including predictable morning OFF episodes) causing clinically significant disability during the 4-week screening period. This will be documented using a participant ON/OFF state registration over 3 consecutive days prior to enrolment.

Exclusion Criteria:

• The participant has or has had one or more of the following conditions that are considered clinically relevant in the context of the study; other neurological disorder, psychiatric disorder, seizure disorder or encephalopathy, respiratory disease, hepatic impairment or renal insufficiency, metabolic disorder, endocrinological disorder, haematological disorder, infectious disorder, any clinically significant immunological condition, or a history of narrow-angle glaucoma

Other inclusion and exclusion criteria may apply.