An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease Patients

Dosing regimen will be decided at a dosing conference prior to cohort 2-8. Dose levels can be
increased, maintained or reduced both between cohorts but also within same cohort. In each
cohort 3 patients with Parkinson's Disease will be treated for 3 days, with increasing dose
each day.

If deemed appropriate the dosing period may be extended to 4 days. In addition, 3 extra
cohorts 9 to 11 are additional cohorts that might be used, if necessary to address the study
objectives. Up to 33 patients can be enrolled

Inclusion Criteria:

- The patient is diagnosed with idiopathic Parkinson Disease (consistent with the UK
Parkinson`s Disease Society Brain Bank Criteria for the Diagnosis of PD).

- The patient's Hoehn and Yahr Staging score is ≤ 3 in the "ON" state.

- The patient experiences motor fluctuations with at least 2.5 hours of "OFF" periods in
the awake time and has predictable morning "OFF" episodes, which have been consistent
within the past 4 weeks.

- The patient currently has a good response to L-DOPA and has been receiving a stable
dose of L-DOPA (≥3 doses per day of standard L-DOPA or ≥3 doses per day of Carbidopa
and L-DOPA, Extended-Release Capsules) during at least four weeks prior to screening.

Exclusion Criteria:

- The patient has cognitive impairment, defined as a Mini Mental State Examination(MMSE)
score ≤ 26 at the Screening Visit.

- The patient has severe disabling dyskinesia

- The patient takes or has taken disallowed recent or concomitant medication (CYP2D6
inhibitors, CYP 3A4 substrate, Dopamine agonists, 5 HT3 antagonists, Anti-viral
(Amantadine))

Other protocol defined inclusion and exclusion criteria may apply