Parkinson's disease
Conditions
Interventions
Lu AF28996 hard capsules
Sponsors
H. Lundbeck A/S
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - The patient is able to read and understand the Subject Information Sheet and Informed Consent Form. - The patient has signed the study-specific Informed Consent Form. - The patient is diagnosed with idiopathic Parkinson*s disease (consistent with the UK Parkinson*s Disease Society Brain Bank Criteria for the Diagnosis of PD) and should not have more than 1 first-degree relative with PD. - The patient*s Modified Hoehn and Yahr score is *3 in the ON state and *4 in the OFF state. - The patient experiences well recognizable and predictable motor fluctuations (at least 1.5 hours of OFF-periods in the awake time, predictable morning OFF episodes included) causing clinically significant disability during the 7-week Screening Period.
Exclusion criteria
Exclusion criteria: - The patient has previously been enrolled in this study. - The patient takes or has taken disallowed recent or concomitant medication (specified in Appendix II of the CSP) or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications during the study. Patients who have taken any non-prescribed systemic or topical medication may participate in the study if, in the opinion of the investigator, the medication will not interfere with the study procedures, study results, or compromise safety. - The patient is a member of the study personnel or of their immediate families, or is a subordinate (or immediate family member of a subordinate) to any of the study personnel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of participants with treatment-emergent adverse events. Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination). 2. Cmax Lu AF28996. Maximum observed plasma concentration of Lu AF28996. 3. AUC(0-24h) Lu AF28996. Area under the plasma concentration time curve from zero to infinity. 4. CL/F Lu AF28996 Oral clearance for Lu AF28996 in plasma. | — |
Countries
Netherlands
Outcome results
None listed