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

NCT ID: NCT04291859

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-26
• Study Completion Date: 2026-02-04

Brief 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 participants with Parkinson's disease.

Detailed Description

The study consists of different parts. Part A of the study will consist of once daily (OD) cohorts (OD Cohort 1 to 3), as well as twice daily (BID) cohorts (BID Cohorts A1 and A2). Part B will consist of 3 cohorts (Cohorts B1, B2, and B3) whereby participants will be administered Lu AF28996 BID.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lu AF28996

Participants in Part A will receive ascending oral doses of Lu AF28996 OD for 14 days in all OD cohorts, followed by down-titration as per Investigator's judgement. For the BID Cohort A1, participants will receive Lu AF28996 BID for 24 days, followed by down-titration as per Investigator's judgement. For the BID Cohort A2, participants will receive Lu AF28996 BID for 39 days, followed by down-titration as per Investigator's judgement.

Participants in Part B (Cohorts B1, B2, and B3) will receive Lu AF28996 BID for 41 days, followed by down-titration as per Investigator's judgement

Group Type: EXPERIMENTAL

Lu AF28996

Intervention Type: DRUG

capsule, orally, doses and dose escalation scheme will be decided upon at dosing conferences

Interventions

Lu AF28996

capsule, orally, doses and dose escalation scheme will be decided upon at dosing conferences

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants diagnosed with idiopathic PD (consistent with the UK PD Society Brain Bank Criteria for the Diagnosis of PD), with not more than 1 first-degree relative who has PD.
• Participants must have a Modified Hoehn and Yahr score ≤4 in the OFF state and ≤3 in the ON state, and a Mini Mental State Examination score >25.
• The OFF/ON amplitude on the MDS-UPDRS Part III at screening must be minimum 30% difference.
• Participants 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 7-week Screening Period, as evaluated by the investigator. This will be documented using a participant ON/OFF state registration over 3 consecutive days prior to enrolment.
• Allowed concomitant medication for PD during the study includes levodopa, monoamine oxidase B inhibitors, COMT inhibitors, anticholinergics, and amantadine. Dopamine agonists are not allowed and should be discontinued ≥4 weeks prior to dosing with Lu AF28996 and until the end of the study.
• Participants diagnosed with idiopathic PD (consistent with the UK PD Society Brain Bank Criteria for the Diagnosis of PD), with not more than 1 first-degree relative who has PD.
• Participants must have a Modified Hoehn and Yahr score ≥2 to ≤4 in the OFF state and ≤3 in the ON state, a MDS-UPDRS Part IV, 4.5 score of 1 or 2, and a MDS-UPDRS Part IV, 4.2 score ≥2 (at least mild functional impact), and a Mini Mental State Examination score >25 at the Screening Visit.
• Participants must currently have a good response to levodopa and be receiving a stable dose of levodopa (≥3 doses per day of levodopa/dopa decarboxylase inhibitor therapy or ≥3 doses per day of levodopa Extended-Release Capsules and LEDD between 400 and 1600, inclusive) for at least 4 weeks prior to screening.
• Participants must experience recognizable and predictable motor fluctuations (with ≥3 hours of OFF periods in the awake time, including predictable morning OFF episodes), causing clinically significant disability during 3 months prior to enrolment, as evaluated by the investigator. The criteria will be documented using Hauser Diary over 3 consecutive days prior to enrolment.
• Participants must experience ≥1 hour daily ON time with troublesome dyskinesia (TD) in the awake time (TD/24 hours while awake) during the last 3 months prior to enrolment as evaluated by the investigator. The criteria will be documented using the Hauser Diary over 3 consecutive days prior to enrolment.
• Allowed concomitant medication for PD during the study includes levodopa, dopamine agonists, if allowed daily dose, monoamine oxidase B inhibitors, COMT inhibitors, anticholinergics, and amantadine.

Exclusion Criteria

• The participant has or 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, or a history of narrow-angle glaucoma.
• Participant has been treated with apomorphine (pen/pump), and/or inhaled levodopa and/or levodopa/carbidopa intestinal gel (LCIG),and/or subcutaneous foslevodopa/foscarbidopa within 6 weeks prior to the Baseline Visit.
• Participants formerly treated with oral or transdermal dopamine agonists must have discontinued 4 weeks prior to screening.
• Participant has a history of Dopamine Agonist Withdrawal Syndrome (DAWS) when dopamine agonists were previously discontinued or reduced.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Locations

CenExel Los Alamitos

Los Alamitos, California, United States

Georgetown University

Washington D.C., District of Columbia, United States

Velocity

Hallandale, Florida, United States

Parkinson's Disease Treatment Center of SW FL

Port Charlotte, Florida, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States

QUEST Research Institute

Farmington Hills, Michigan, United States

Neurology Consultants of Nebraska

Omaha, Nebraska, United States

Inland Nortwest Research

Spokane, Washington, United States

Caen Normandy University

Caen, Basse-Normandie, France

Curiositas-ad-sanum

Hamburg, , Germany

QPS Netherlands BV

Leeuwarden, , Netherlands

Hospital Vall d´Hebron

Barcelona, , Spain

Hosp. General Catalunya

Mira-Sol, , Spain

Virgen Del Roccio

Seville, , Spain

Countries

United States; France; Germany; Netherlands; Spain

Other Identifiers

2019-001280-77

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

18252A

Identifier Type: -

Identifier Source: org_study_id