Lu AF28996 for Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new drug called Lu AF28996 to see if it is safe and well-tolerated in people with Parkinson's disease. The study will check how the body processes the drug and if it causes any side effects. Participants will take the drug at different frequencies during the study.
Will I have to stop taking my current medications?
Participants can continue taking certain Parkinson's medications like levodopa, monoamine oxidase B inhibitors, COMT inhibitors, anticholinergics, and amantadine. However, dopamine agonists must be stopped at least 4 weeks before starting the trial and cannot be used during the study.
Who Is on the Research Team?
Email contact via H. Lundbeck A/S
Principal Investigator
LundbeckClinicalTrials@Lundbeck.com
Are You a Good Fit for This Trial?
This trial is for men and women with Parkinson's Disease who respond well to levodopa, have been on a stable dose for at least 4 weeks, and experience significant motor fluctuations. They should not have other major neurological issues or serious health conditions like liver problems, respiratory diseases, or immune disorders.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Participants receive ascending oral doses of Lu AF28996 once daily for 14 days or twice daily for 24 to 39 days, followed by down-titration
Treatment Part B
Participants receive Lu AF28996 twice daily for 41 days, followed by down-titration
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lu AF28996
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