In short
NT-0796 is an investigational substance being studied for Parkinson's disease. It is given by mouth as a suspension capsule. One Phase 1 clinical trial, completed in the European Union, evaluated its safety and tolerability in 14 healthy volunteers and patients with Parkinson's disease. The trial primarily measured treatment-emergent adverse events and changes in clinical laboratory values.
NT-0796 is an investigational substance, meaning it is not yet an authorised medicine. It is being studied for Parkinson's disease, a progressive nervous system disorder that affects movement. The available clinical trial data comes from the EU Clinical Trials Information System (CTIS). The substance is classified under nervous system diseases in the registry records. This page explains what is known about NT-0796 from that single completed Phase 1 trial.
Key points
- NT-0796 is an investigational oral drug studied in Parkinson's disease.
- The only registered trial is a Phase 1 study that has been completed.
- The trial enrolled 14 participants, including healthy volunteers and patients with Parkinson's disease.
- The drug was given as a 300 mg oral suspension capsule.
- The main goal was to assess safety and tolerability, including treatment-emergent adverse events.
- The trial also used lidocaine and nadroparin as comparison or auxiliary interventions.
What is NT-0796?
NT-0796 is an investigational drug that has not received marketing authorisation. It is studied in the therapeutic area of nervous system diseases, specifically Parkinson's disease. The substance is given by mouth as a suspension capsule. No other names or development codes for NT-0796 are listed in the trial record. The trial record does not state whether NT-0796 is a chemical or protein-based substance, nor does it provide an ATC code.
How does NT-0796 work?
The available trial record does not describe the mechanism of action of NT-0796. No molecular target, pathway, or pharmacological class is stated in the registry data. Therefore, how NT-0796 might work in the body remains unknown from the provided sources.
Which conditions is it used or studied for?
- Parkinson's disease — a progressive disorder of the nervous system that affects movement, often causing tremors, stiffness, and slowing of movement. NT-0796 was studied in this condition in one Phase 1 trial.
How is NT-0796 given?
NT-0796 is given by mouth as a suspension capsule. In the registered trial, the dose used was 300 mg. No other pharmaceutical forms or routes of administration are reported in the available data.
What do the clinical trials show?
Only one clinical trial of NT-0796 is registered in the provided data. It is a Phase 1 interventional study that has been completed. The trial enrolled 14 participants, including both healthy volunteers and patients with Parkinson's disease. The primary outcomes were the incidence of treatment-emergent adverse events (TEAEs) and changes in clinical laboratory values. The brief summary states that the study evaluated the safety and tolerability of the NT-0796 suspension capsule formulation. The trial also included lidocaine hydrochloride injection and nadroparin injection as other interventions, which served as comparison or auxiliary treatments, not as the studied substance.
Who can take part in these trials?
The completed Phase 1 trial enrolled healthy volunteers and patients with Parkinson's disease. No further inclusion or exclusion criteria are given in the registry record. Because the trial is completed, no new participants are being recruited for this specific study.
What are the trials measuring?
The main measurements in the trial were safety outcomes. These included the incidence of treatment-emergent adverse events, which are any unwanted medical events that appear after treatment starts. The trial also measured changes in clinical laboratory values, such as blood tests. No efficacy endpoints, such as improvement in Parkinson's symptoms, were listed as primary outcomes in this early-phase study.
What side effects are known?
The available registry record does not report specific side effects of NT-0796. The trial measured treatment-emergent adverse events as a primary outcome, but the results are not included in the provided data. Therefore, no known side effects can be described from these sources.