Lu AF28996 addition for adults with Parkinson's and motor fluctuations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional study evaluating Lu AF28996 versus placebo in adults with Parkinson's disease who continue to experience motor fluctuations despite optimized non-invasive therapy. Eligible participants have established PD with a confirmed diagnosis and a range of disease severity defined by Hoehn and Yahr staging, and report daily OFF-time and disability due to motor fluctuations. Participants will receive Lu AF28996 or placebo in addition to their current PD medications to see if the new treatment extends periods of good motor control and reduces bothersome dyskinesia. The trial excludes prior exposure to Lu AF28996, recent trial participation, and certain pregnancy-related conditions. The study is sponsored by H. Lundbeck A/S with sites in Michigan and Texas.

Why it matters

Who can join: the full rules

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

Where it's running

• Quest Research Institute - Alcanza - HyperCore - PPDS
  Farmington Hills, Michigan, United States Recruiting
• Central Texas Neurology Consultants (CTNC)
  Round Rock, Texas, United States Recruiting

Study contacts

• Study coordinator: Email contact via H. Lundbeck A/S
• Email: HQ_Medinfo@Lundbeck.com
• Phone: +45 36301311

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.