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Testing Lu AF28996 when movement symptoms vary

Researchers study an experimental medicine in adults whose movement symptoms still fluctuate despite adjustments to their usual Parkinson’s treatment.

Testing a treatment or activity · Study reference: NCT07514858

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

Open the official registry record ↗

Who can join?

Ages 40 years to 85 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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
Full study name & original research details

Official study title

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose Trial of Lu AF28996 in Adults With Parkinson's Disease Experiencing Motor Fluctuations

Short title used by the registry

A Trial Investigating Lu AF28996 in Adults With Parkinson's Disease Who Have Motor Fluctuations

Original description

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.

Conditions reported: Parkinson's Disease

Study type
Interventional
Interventions
Lu AF28996; Placebo
Phases
PHASE2
Sponsor
H. Lundbeck A/S
Start date reported by registry
2026-07-28 (actual)

Registry updated: 2026-09-08 · Status last verified by the registry submitter: 2026-09

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Email contact via H. Lundbeck A/S · +45 36301311 · HQ_Medinfo@Lundbeck.com

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Quest Research Institute - Alcanza - HyperCore - PPDS

Farmington Hills, Michigan, United States

Recruiting

Central Texas Neurology Consultants (CTNC)

Round Rock, Texas, United States

Recruiting

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.