New Parkinson's pill aims to cut 'OFF' time and ease daily struggles
NCT ID NCT07514858
First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times
Summary
This Phase 2 trial tests whether adding Lu AF28996 to standard Parkinson's medications can extend the time patients feel their movement symptoms are well-controlled (called 'good ON time'). About 150 adults with Parkinson's who still experience motor fluctuations despite optimized treatment will receive either the drug or a placebo. The main goal is to see if the drug increases daily good ON time without troublesome dyskinesia over 19 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lu AF28996
- What this could lead to
- If successful, this could provide a new add-on medication to help Parkinson's patients spend more time with well-controlled movement symptoms and less time in 'OFF' periods.
- What could go wrong
- This is an early Phase 2 trial with only 150 participants, so results may not confirm benefit. The drug may cause side effects or fail to outperform placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Central Texas Neurology Consultants (CTNC)
RECRUITINGRound Rock, Texas, 78681-3579, United States
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Quest Research Institute - Alcanza - HyperCore - PPDS
RECRUITINGFarmington Hills, Michigan, 48334-2973, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Colon tissue may hold clues to telling Parkinson's apart from Look-Alike diseases
- A genetic roadmap for Parkinson's: testing thousands to unlock clues
- Can gentle touch therapy calm Parkinson's tremors?
- Stem cell infusions aim to slow Parkinson's progression
- Can an inhaled levodopa ease Parkinson's OFF episodes? a study asks patients.