Interventional, Open-label, Exploratory Study, Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AF28996 in Patients With Parkinson's Disease

Who is this study for? Older adult patients with Parkinson's Disease
What treatments are being studied? Lu AF28996
Status: Active_not_recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
CenExel Los Alamitos
Los Alamitos
Washington, D.c.
Georgetown University
Washington D.c.
Florida
Velocity
Hallandale
Parkinson's Disease Treatment Center of SW FL
Port Charlotte
Georgia
Atlanta Center for Medical Research
Atlanta
Hawaii
Hawaii Pacific Neuroscience
Honolulu
Michigan
QUEST Research Institute
Farmington Hills
Nebraska
Neurology Consultants of Nebraska
Omaha
Washington
Inland Nortwest Research
Spokane
Other Locations
France
Caen Normandy University
Caen
Germany
Curiositas-ad-sanum
Hamburg
Netherlands
QPS Netherlands BV
Leeuwarden
Spain
Hospital Vall d´Hebron
Barcelona
Hosp. General Catalunya
Mira-sol
Virgen Del Roccio
Seville
Time Frame
Start Date: 2020-02-26
Completion Date: 2026-02-04
Participants
Target number of participants: 57
Treatments
Experimental: 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
Related Therapeutic Areas
Sponsors
Leads: H. Lundbeck A/S

This content was sourced from clinicaltrials.gov

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