Recruiting
Phase 2

Lu AF28996

Sponsor:

H. Lundbeck A/S

Code:

NCT07514858

Conditions

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Lu AF28996

Placebo

Study Details

Brief summary:

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

Parkinson's Disease

Study ID

NCT07514858

Start date

Jul 28, 2026

Status verified date

Sep, 2026

Completion date

Oct 3, 2028

Anticipated

Primary completion date

Oct 3, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lu AF28996

Participants will receive Lu AF28996 as add-on to concomitant PD medications for up to Week 23.

placebo comparator: Placebo

Participants will receive Lu AF28996 matching placebo as add-on to concomitant PD medications for up to Week 23.

Interventions

Lu AF28996

Lu AF28996 will be administered orally per schedule specified in the arm description.

Placebo

Placebo matching to Lu AF28996 will be administered orally per schedule specified in the arm description.

Primary outcome measure

  • Change From Baseline to Week 19 in Daily Good ON Time Based on the Participant's Hauser Diary Entries [ Time Frame: Baseline, Week 19 ]

Central Contacts and Locations

Central contacts

Email contact via H. Lundbeck A/S

+45 36301311HQ_Medinfo@Lundbeck.com

Locations

Quest Research Institute - Alcanza - HyperCore - PPDS

Recruiting

Farmington Hills, Michigan, United States, 48334-2973

Central Texas Neurology Consultants (CTNC)

Recruiting

Round Rock, Texas, United States, 78681-3579

More Information

Sponsor

H. Lundbeck A/S

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by H. Lundbeck A/S on 2026-09-08.