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

Last updated: February 12, 2025
Sponsor: H. Lundbeck A/S
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Lu AF28996

Clinical Study ID

NCT04291859
18252A
2019-001280-77
  • Ages 35-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants diagnosed with idiopathic PD (consistent with the UK PD Society BrainBank Criteria for the Diagnosis of PD), with not more than 1 first-degree relativewho has PD.

  • Participants must have a Modified Hoehn and Yahr score ≤4 in the OFF state and ≤3 inthe 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 (withat least 1.5 hours of OFF periods in the awake time, including predictable morningOFF episodes), causing clinically significant disability during the 7-week ScreeningPeriod, as evaluated by the investigator. This will be documented using aparticipant ON/OFF state registration over 3 consecutive days prior to enrolment.

  • Allowed concomitant medication for PD during the study includes levodopa, monoamineoxidase B inhibitors, COMT inhibitors, anticholinergics, and amantadine. Dopamineagonists are not allowed and should be discontinued ≥4 weeks prior to dosing with LuAF28996 and until the end of the study.

  • Participants diagnosed with idiopathic PD (consistent with the UK PD Society BrainBank Criteria for the Diagnosis of PD), with not more than 1 first-degree relativewho 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 PartIV, 4.2 score ≥2 (at least mild functional impact), and a Mini Mental StateExamination score >25 at the Screening Visit.

  • Participants must currently have a good response to levodopa and be receiving astable dose of levodopa (≥3 doses per day of levodopa/dopa decarboxylase inhibitortherapy 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 OFFepisodes), causing clinically significant disability during 3 months prior toenrolment, as evaluated by the investigator. The criteria will be documented usingHauser 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 toenrolment as evaluated by the investigator. The criteria will be documented usingthe Hauser Diary over 3 consecutive days prior to enrolment.

  • Allowed concomitant medication for PD during the study includes levodopa, dopamineagonists, if allowed daily dose, monoamine oxidase B inhibitors, COMT inhibitors,anticholinergics, and amantadine.

Exclusion

Exclusion Criteria:

  • The participant has or had one or more of the following conditions that areconsidered clinically relevant in the context of the study; other neurologicaldisorder, psychiatric disorder, seizure disorder or encephalopathy, respiratorydisease, hepatic impairment or renal insufficiency, metabolic disorder,endocrinological disorder, haematological disorder, infectious disorder, anyclinically significant immunological condition, or a history of narrow-angleglaucoma.

  • Participant has been treated with apomorphine (pen/pump), and/or inhaled levodopaand/or levodopa/carbidopa intestinal gel (LCIG),and/or subcutaneousfoslevodopa/foscarbidopa within 6 weeks prior to the Baseline Visit.

  • Participants formerly treated with oral or transdermal dopamine agonists must havediscontinued 4 weeks prior to screening.

  • Participant has a history of Dopamine Agonist Withdrawal Syndrome (DAWS) whendopamine agonists were previously discontinued or reduced.

Other inclusion and exclusion criteria may apply.

Study Design

Total Participants: 63
Treatment Group(s): 1
Primary Treatment: Lu AF28996
Phase: 1
Study Start date:
February 26, 2020
Estimated Completion Date:
February 04, 2026

Study 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.

Connect with a study center

  • Caen Normandy University

    Caen, Basse-Normandie 14033
    France

    Active - Recruiting

  • Curiositas-ad-sanum

    Hamburg, 83527
    Germany

    Active - Recruiting

  • QPS Netherlands BV

    Leeuwarden, 8934 AD
    Netherlands

    Completed

  • Hosp. General Catalunya

    Mira-Sol, 08195
    Spain

    Active - Recruiting

  • CenExel Los Alamitos

    Los Alamitos, California 90720
    United States

    Active - Recruiting

  • Velocity

    Hallandale Beach, Florida 33009
    United States

    Active - Recruiting

  • Parkinson's Disease Treatment Center of SW FL

    Port Charlotte, Florida 33980
    United States

    Active - Recruiting

  • Atlanta Center for Medical Research

    Atlanta, Georgia 30331
    United States

    Completed

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii 96817
    United States

    Active - Recruiting

  • QUEST Research Institute

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • Inland Nortwest Research

    Spokane, Washington 99202
    United States

    Active - Recruiting

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