Interventional, open-label, exploratory study, investigating the safety, tolerability, pharmacokinetics, and efficacy of Lu AF28996 in patients with Parkinson*s disease

Completed

Conditions: Parkinson's disease
10028037

Registration Number: NL-OMON52830

Lead Sponsor: H. Lundbeck A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

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

- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Number of participants with treatment-emergent adverse events.<br /><br>Safety and tolerability based on the safety assessments (clinical safety<br /><br>laboratory tests, vital signs, weight, ECG parameters and physical<br /><br>examination).<br /><br>2. Cmax Lu AF28996.<br /><br>Maximum observed plasma concentration of Lu AF28996.<br /><br>3. AUC(0-24h) Lu AF28996.<br /><br>Area under the plasma concentration time curve from zero to infinity.<br /><br>4. CL/F Lu AF28996<br /><br>Oral clearance for Lu AF28996 in plasma. </p><br>

Secondary Outcome Measures