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

Sponsor
H. Lundbeck A/S
Study ID
NCT07514858
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Apr 7, 2026
Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Dec 30, 2028
Completion
Dec 30, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

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