Phase
Condition
N/ATreatment
Lu AF28996
Clinical Study ID
Ages 35-85 All Genders
Study Summary
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
Study Description
Connect with a study center
Caen Normandy University
Caen, Basse-Normandie 14033
FranceActive - Recruiting
Curiositas-ad-sanum
Hamburg, 83527
GermanyActive - Recruiting
QPS Netherlands BV
Leeuwarden, 8934 AD
NetherlandsCompleted
Hosp. General Catalunya
Mira-Sol, 08195
SpainActive - Recruiting
CenExel Los Alamitos
Los Alamitos, California 90720
United StatesActive - Recruiting
Velocity
Hallandale Beach, Florida 33009
United StatesActive - Recruiting
Parkinson's Disease Treatment Center of SW FL
Port Charlotte, Florida 33980
United StatesActive - Recruiting
Atlanta Center for Medical Research
Atlanta, Georgia 30331
United StatesCompleted
Hawaii Pacific Neuroscience
Honolulu, Hawaii 96817
United StatesActive - Recruiting
QUEST Research Institute
Farmington Hills, Michigan 48334
United StatesActive - Recruiting
Inland Nortwest Research
Spokane, Washington 99202
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.