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

  • STATUS
    Recruiting
  • participants needed
    10
  • sponsor
    H. Lundbeck A/S
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Updated on 16 February 2024
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mini-mental state examination
levodopa
benserazide
carbidopa
mental state examination

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 Patients With Parkinson's Disease

Details
Condition Parkinson's Disease, Parkinson's Disease
Age 45years - 75years
Treatment Lu AF28996
Clinical Study IdentifierNCT04291859
SponsorH. Lundbeck A/S
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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