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

Completed · Phase 1

Conditions studied: Parkinson Disease

In brief

To evaluate the safety, tolerability, pharmacokinetics, and efficacy of the Lu AE04621 and metabolite after ascending oral doses of Lu AE04621 in patients with Parkinson's Disease.

Key facts

Study ID

NCT02649608

Run by

H. Lundbeck A/S

People needed

15

Starts

2016-01-01

Expected to finish

2016-12-01

Last updated by the study team

2021-02-24

Who can join

Age: 45 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• US1251 — Hallandale, Florida, United States
• US1126 — Orlando, Florida, United States
• US1352 — Chicago, Illinois, United States
• US1084 — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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