Erik Uden 🍑Tomorrow I will begin my participation in a medical study for the coming 19 days, testing a compound meant to treat multiple sklerosis. The specific compound name is RO7268489, which has been tested on 67 people in four previous studies as of yet. Both the FDA and the EMA have not approved this compound for a treatment.
Multiple sklerosis (MS) is caused when a protective coating on nerve cells (called myelin) is damaged in the central nervous system. A majority of approved drugs for the treatment of MS only influence the immune system in a way that relapse rates are reduced. The compound I am testing targets mechanisms in the brain responsible for worsening the disability, hence improving neurological functions.
My study is the fifth of this kind, ever, and is conducted in Groningen (Netherlands) by the ICON plc, a private healthcare intelligence and clinical research organization trading at the Nasdaq. The specific code for the study I'm participating in is PRA-RPUBIU40-0H13WG.
This compound is well tolerated in doses below 2mg, and due to unwanted side effects¹, the medical company sponsoring this study has decided to only continue testing below that dosis. Before this, it was tested until 6mg.
This part of the study is a “Multiple Ascending Dose” study, meaning it's supposed to evaluate safety and tolerability of the compound on the human body, as well as how quickly it gets digested, or how the human body generally responds to it (pharmacokinetics). Three groups of the compound are tested, each divided in two subgroups, one of which truly takes the compound, the other gets the placebo.
Group 1 gets 0.2mg of the compound
Group 2 gets 0.6mg of the compound
Group 3 gets 1.0mg of the compound
I am part of group 2 (b), which has 6 subjects taking the real drug, and two taking a placebo, meaning there's a 25% chance I'm simply drinking a glass of water for three weeks.
The research facility aims to also see the effects of the compound in the body (pharmacodynamics).
In order to do so, they will take cerebrospinal fluid samples through a lumbar puncture three times throughout the study.
If anything happens to me in the coming four years as a result of the effects of this compound or study, I have an insurance of 650,000 € (same amount is paid out to my family in the case of me dying).
Whatever I'll experience throughout the coming weeks is what multiple sklerosis patients will have to listen to as disclaimers whenever they'll take this medicine once it's approved.
I'll document everything I experience, both side effects and my overall thoughts, in this thread. That is for both my own sake, and maybe to document a piece of medical history, if it ever comes that far. Additionally, this may not be something you hear of a lot, hence I wanted to put it out there.
If you have any questions, I'll be happy to answer them!
¹ Side effects include: anxiety attacks & increased heart rate, hyperventilation, motor unsteadiness, severe paranoia, trouble speaking, trouble completing sentences, trouble verbalizing thoughts and a feeling of loss of control (which lasted 3-5 days until full recovery), increased suicidal tendencies
Aral Balkan
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