Bezpieczeństwo i penetracja do CNS mirivadelgatu oraz placebo u pacjentów z chorobą Parkinsona – randomizowane, podwójnie zaślepione, faza 2a

Randomization and start of medication

After joining the study you receive a code that determines whether you will take mirivadelgat or a matching placebo.

The study medication is taken orally as one capsule each day.

If you are assigned to the active Group the capsule contains 300 mg of mirivadelgat; the placebo capsule contains no active substance.

Daily medication intake

You take the assigned capsule once every day for a total of 12 weeks.

The dose is the same each day; no dose adjustments are required.

It is important to take the capsule at roughly the same time each day.

Regular safety checks

Throughout the 12‑week period you attend scheduled visits or phone contacts where the study staff ask about any side effects or health problems.

Any adverse event is recorded and evaluated.

Week 12 assessment

At the end of week 12 you come to the study site for a final visit.

A sample of cerebrospinal fluid (CSF) is taken by lumbar puncture to measure the level of the mirivadelgat metabolite AD‑835 and to analyse biomarkers such as 4‑hne protein adducts.

Blood is also drawn to compare CSF and plasma concentrations.

The study medication is stopped after this visit.

Study completion

After the week 12 visit the trial is considered finished for you.

The study team may keep in contact for a short period to collect any late information, but no further medication is given.