NCT07514858

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2026-06-30
• Primary completion: 2028-12-30
• Completion: 2028-12-30
• First posted: 2026-04-07
• Last updated: 2026-04-07

Regulatory

• FDA-regulated drug study