Lu AF28996 for Parkinson's Disease
(DARE2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Email contact via H. Lundbeck A/S
Principal Investigator
H. Lundbeck A/S
Are You a Good Fit for This Trial?
This trial is for adults diagnosed with Parkinson's disease at least 3 years ago, who are over age 30 at diagnosis and still have movement problems (motor fluctuations) despite current medications. Participants must experience daily periods when their symptoms aren't well controlled.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Trial Overview
The study tests whether adding a new drug called Lu AF28996 to usual Parkinson’s medications helps control movement symptoms better than a placebo. Participants are randomly assigned to receive either the new drug or an inactive pill.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive Lu AF28996 as add-on to concomitant PD medications for up to Week 23.
Participants will receive Lu AF28996 matching placebo as add-on to concomitant PD medications for up to Week 23.
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lundbeck A/S
Lead Sponsor
Charl van Zyl
H. Lundbeck A/S
Chief Executive Officer since 2023
Degree in Medical Biochemistry from the University of Cape Town, South Africa
Johan Luthman
H. Lundbeck A/S
Chief Medical Officer since 2019
MD from the University of Gothenburg, Sweden
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