A Trial Investigating Lu AF28996 in Adults With Parkinson's Disease Who Have Motor Fluctuations
Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose Trial of Lu AF28996 in Adults With Parkinson's Disease Experiencing Motor Fluctuations
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 40 Years to 85 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests Lu AF28996 added to current Parkinson’s medicines in adults whose movement symptoms are still not well controlled at times. It aims to see if the added drug gives people more time with good movement control and without bothersome unwanted movements.
This trial will evaluate the effects of Lu AF28996 in adults with Parkinson's disease (PD) experiencing motor fluctuations despite optimized non-invasive symptomatic treatment. These are individuals with PD who take medications to control movement symptoms, such as slowness, stiffness, and tremor, but still experience periods of time when their medication does not adequately control their motor symptoms. Some may also experience dyskinesia (other type of involuntary movements) as a side effect of their PD medications. The main goal of the trial is to learn whether adding Lu AF28996 to participants' optimized PD medications will help extending the time they spend with their movement symptoms being well-controlled and without bothersome dyskinesia.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You were diagnosed with Parkinson’s at least 3 years ago, after age 30, and your diagnosis meets the study’s medical standards.
- Your Parkinson’s stage on the study’s rating scale is 3 or lower when medicine is working (ON), and 2 to 4 when it is not working well (OFF).
- For at least 3 months before screening, you have had clear, regular changes in movement control that the study doctor judges cause major problems with daily life.
- You have OFF time each day while awake, when your medicine does not control movement symptoms well.
Who can't join
- You have taken Lu AF28996 before.
- You took part in another clinical trial less than 30 days before screening.
- You are pregnant, breastfeeding, planning to become pregnant, or able to become pregnant but unwilling to use suitable birth control.
- You took an experimental drug within 3 months before screening, or within 5 drug half-lives, whichever is longer. A half-life is the time it takes the body to clear half of a drug.
- Your score on the MoCA thinking and memory test is 24 or lower, after adjusting for education.
- You have another illness that causes Parkinson’s-like symptoms, including symptoms caused by drugs, certain genetic disorders such as Wilson’s disease, brain inflammation, or Parkinson Plus syndromes.
- You have severe, widespread unwanted movements that the study doctor thinks could make taking part unsafe, such as by causing falls or food or liquid to enter your airway.
- Your movement symptoms change widely and without warning, based on the study doctor’s judgment or a score of 3 or higher on the study’s rating of unpredictable movement changes.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Key Inclusion Criteria: * The participant was diagnosed with PD ≥3 years ago, with the diagnosis being established after the age of 30 years and consistent with the Movement Disorders Society (MDS) Clinical Diagnostic Criteria for "clinically established" or "clinically probable" PD. * The participant has a modified Hoehn and Yahr scale (mH\&Y) stage ≤3 in the ON state and ≥2 and ≤4 in the OFF state. * The participant reports well recognizable, consistent motor fluctuations causing significant disability per investigator's judgement over a period of ≥3 months prior to screening. * The participants report motor fluctuations each day as measured by OFF-time during awake hours. Key Exclusion Criteria: * The participant has previously been dosed with Lu AF28996. * The participant has participated in a clinical trial \<30 days prior to screening. * The participant is pregnant, breastfeeding, intends to become pregnant, or is of child-bearing potential and not willing to use adequate contraceptive methods. * The participant has taken any investigational medicinal product (IMP) \<3 months or \<5 half-lives, whichever is longer, prior to screening. * The participant has a Montréal Cognitive Assessment (MoCA) score ≤24 (adjusted for education). * The participant has an atypical, secondary, or drug-induced Parkinsonism (for example, metoclopramide, flunarizine), metabolic identified neurogenetic disorders (for example, Wilson's disease), encephalitis, or Parkinson Plus syndromes or other forms of atypical Parkinsonian syndromes (for example, progressive supranuclear palsy and multiple system atrophy). * The participant has severe, pervasive, disabling dyskinesia which, in the setting of the present trial, may interfere with his/her safe participation in the trial (for example, threat to falling, aspiration, etc.) as judged by the investigator. * The participant has unpredictable motor fluctuations as evidenced by an MDS-UPDRS Part IV Item 4.5 score ≥3 at screening and/or experiences wide, unpredictable fluctuations of PD symptoms per investigator's clinical judgement. Note: Other protocol defined inclusion and exclusion criteria may apply
Study sites (2)
MI
- Quest Research Institute - Alcanza - HyperCore - PPDS · Farmington Hills, MI 48334-2973More trials in Farmington Hills
TX
- Central Texas Neurology Consultants (CTNC) · Round Rock, TX 78681-3579More trials in Round Rock