In short
LU AF28996 DH1 is an investigational medicine being studied in adults with Parkinson’s disease who have motor fluctuations. One Phase 2 trial is currently authorised, with a planned enrollment of 221 participants. The study aims to assess whether the medicine can improve daily good ON time, a measure of how long Parkinson’s symptoms are well controlled.
Key points
- LU AF28996 DH1 is an investigational medicine with no marketing authorisation.
- It is being studied in a Phase 2 trial in adults with Parkinson’s disease who have motor fluctuations.
- The trial is authorised and plans to enroll 221 participants.
- The medicine is given orally, with a placebo used as a comparison arm.
- The main measure is daily good ON time based on Hauser diary entries.
What is LU AF28996 DH1?
LU AF28996 DH1 is an investigational medicine with no marketing authorisation in these records. It is a chemically synthesised substance being developed for the treatment of Parkinson’s disease. The substance is under investigation in a clinical trial setting and is not yet available as a prescribed medicine.
How does LU AF28996 DH1 work?
The exact mechanism of action of LU AF28996 DH1 is not described in the available registry data. The clinical trial record indicates that the medicine is being assessed for its ability to improve motor complications in Parkinson’s disease, specifically by measuring changes in daily good ON time. No further details on the molecular target or pharmacological action are provided in the source data.
Which conditions is LU AF28996 DH1 studied for?
- Parkinson’s disease — a progressive neurological condition that affects movement. The trial focuses on adults who experience motor fluctuations, meaning their symptoms are not consistently controlled throughout the day.
How is LU AF28996 DH1 given?
LU AF28996 DH1 is given orally, according to the trial registry record. The trial includes multiple arms with the active medicine at different doses, as well as a placebo arm for comparison. The specific dose levels are not reported in the registry data.
What do the clinical trials show?
One Phase 2 trial of LU AF28996 DH1 is currently authorised. The trial is interventional and plans to enroll 221 adults with Parkinson’s disease who have motor fluctuations. The primary outcome is the change from baseline to week 19 in daily good ON time, measured using the participant’s Hauser diary entries. Good ON time refers to periods when Parkinson’s symptoms are well controlled and the person can function normally. The trial compares the active medicine against a placebo. As the trial is authorised but not yet completed, no efficacy results are available in the registry record.
What side effects are known?
The available registry data does not include information on side effects of LU AF28996 DH1. As this is an investigational medicine in an early phase of clinical research, the side effect profile is not yet established in the provided sources.