Lu AF28996 in Patients With Parkinson's Disease (PD)
Lu AF28996 in Patients With Parkinson's Disease (PD)
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 Patients With Parkinson's Disease
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 Staging ≤4 in 'OFF'
 and ≤3 in 'ON' state and a Mini Mental State Examination Score >26.

 -  Patients must currently have a good response to levodopa, and be 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. If the patient's response to Levodopa has not been
 previously documented in medical records, the patient will be submitted to a Levodopa
 challenge test while in practically defined OFF state prior to enrolment.

 -  Patients 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 during a defined period of 3 consecutive days prior to
 enrolment, using a patient diary.

 Exclusion Criteria:

 -  The patient 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, elevated intra-ocular pressure or is at risk of acute narrow-angle glaucoma

 Other in- and exclusion criteria may apply