ABOUT THE CLINICAL TRIAL FACILITY

Together with the nurse – Mrs. Maria Zugehoer we have over twenty years of experience in clinical trials in multiple sclerosis and other neurological diseases.

Currently, in multiple sclerosis, we conduct phase III and IV trials aimed at assessing the safety, efficacy and determination of the optimal therapeutic dose of a particular drug used to treat other autoimmune diseases before entering the pharmaceutical market for the treatment of multiple sclerosis or of drugs registered for the treatment of multiple sclerosis after modifying the molecule to improve their effectiveness, dosage regime, safety, or to compare the effectiveness of two already registered drugs.

Each clinical trial is conducted according to strictly defined rules, which is included in the clinical trial protocol.

The principles of the protocol are strictly followed by our team in the conducted trial.

Clinical trials include patients who:

• were not qualified for immunomodulatory treatment offered by the NFZ (National Health Fund),
• completed the treatment offered by the NFZ, but the course of the disease demonstrates its ineffectiveness (the disease is still active),
• are in the course of treatment with first-line drugs and the course of the disease demonstrates its ineffectiveness: relapses, progression of disability or adverse events.

All patients must meet the inclusion and exclusion criteria for the study.

Our current team

Principal investigators

Adriana Chełminiak MD – neurologist
Justyna Hryniewicz, MD – neurologist
Daniel Zielonka, MD, PhD, DSc – neurologist

Subinvestigator

Ada Piotrowska – MD – neurologist

Psychologists

Anna Alejska

Aleksandra Brychcy

Anna Rajewska

Anna Schmidt-Piątek

Primary clinical study coordinator

Anna Kubiak

Clinical study coordinators

Aleksander Szepke

Coordinating nurse

Maria Zugehoer

Nurse

Aneta Nijak

Investigational product administrator

Anna Kubiak

The competences of the team were confirmed during audits carried out in our Facility by sponsors, Contact Research Organization (CRO) and the American Food and Drug Administration (FDA).

Currently, we use first and second line immunomodulatory drugs in our clinical trials.

Patients receiving these medications are carefully monitored during the control visits, which are held every two weeks, every month or every 3 months.

Such visits include: interview, physical examination, neurological examination, extended tests of motor, cognitive, visual functions and also of emotional state (depression rating scale), laboratory tests – blood sampling (biochemistry, hematology, coagulation) and urine (general test).

If needed, specialist consultations are carried out: internist, cardiologist, nephrologist, hepatologist, dermatologist, ophthalmologist, pulmonologist.

All clinical trials procedures are free of charge, as well as travel expenses.

Clinical trials give patients the opportunity to have samely effective and individually selected treatment as in other countries (Rocky Mountain MS Center www.mscenter.org).