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

NCT07514858 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 20309A
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

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

  Baseline, Week 19

Secondary Outcomes (27)

• Change From Baseline to Week 19 in Daily OFF Time Based on Participant's Hauser Diary Entries

  Baseline, Week 19

• Change From Baseline to Week 19 in Daily ON Time With Troublesome Dyskinesia Based on Participant's Hauser Diary Entries in Participants Reporting ≥1 Hour of Daily ON Time With Troublesome Dyskinesia at Baseline

  Baseline, Week 19

• Change From Baseline to Week 19 in Participant's Unified Dyskinesia Rating Scale (UDysRS) Total Score in Participants Reporting ≥1 Hour of Daily ON Time With Troublesome Dyskinesia at Baseline

  Baseline, Week 19

• Participant's Achievement at Week 19 of a Reduction in Daily OFF Time, Defined as >1.5 Hour/Day Reduction

  Week 19

• Participant's Achievement at Week 19 of an Increase in Daily Good ON Time >1.5 Hour/Day

  Week 19

Study Arms (2)

Lu AF28996

EXPERIMENTAL

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

Drug: Lu AF28996

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Lu AF28996 DRUG

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

Lu AF28996

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (2)

Quest Research Institute - Alcanza - HyperCore - PPDS

Farmington Hills, Michigan, 48334-2973, United States

RECRUITING

Central Texas Neurology Consultants (CTNC)

Round Rock, Texas, 78681-3579, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Email contact via H. Lundbeck A/S

  H. Lundbeck A/S

  STUDY DIRECTOR

Central Study Contacts

Email contact via H. Lundbeck A/S

CONTACT

+45 36301311; HQ_Medinfo@Lundbeck.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start: July 28, 2026
• Primary Completion (Estimated): October 3, 2028
• Study Completion (Estimated): October 3, 2028
• Last Updated: September 8, 2026

Record last verified: 2026-09

Locations

US (2)