Parkinson's Disease study: Lu AF28996
Official title A Trial Investigating Lu AF28996 in Adults With Parkinson's Disease Who Have Motor Fluctuations
ClinicalTrials.gov ID: NCT07514858
What this study is testing
What is Lu AF28996?
An investigational oral medicine being studied for Parkinson's disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if Lu AF28996 can increase the time patients feel their movement symptoms are well controlled and reduce unwanted involuntary movements.
- Who it's for
- Adults with Parkinson’s disease who still have motor fluctuations despite taking their usual medications.
- What's involved
- Participants will take Lu AF28996 in addition to their current Parkinson’s drugs and will have regular visits for monitoring and tests.
- Time commitment
- The trial lasts several months, with scheduled clinic visits and assessments throughout the study period.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 85
You may be able to join if
- 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...
- 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...
- The participants report motor fluctuations each day as measured by OFF-time during awake hours. Key
You likely can't join if
- 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...
- 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...
See the full eligibility 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...
- 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
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Farmington Hills, Michigan, United States
- Round Rock, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Farmington Hills, Michigan, United States; Round Rock, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.