Tomorrow I will begin my participation in a medical study for the coming 19 days, testing a compound meant to treat multiple sclerosis. 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 sclerosis (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 sponsor of this study is Roche (F. Hoffmann-La Roche AG), a private healthcare company. 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
At 06:16, writing this as I'm walking: I have just left my house and will begin the drive to Groningen via public transport shortly.
2024.09.03 | Trip to ICON
--------------
-------------
╔═════[
Hannover]══════
║
╠═
╡06:46 Hannover
╠═
╡09:14 Leer (Ostfriesland) zm
╠═╡IC 2436 249 km
║
╠═════════Leer═════════
║
╠═╡09:30 Leer (Ostfriesland)
╠═╡10:25 Groningen Hoofdstation
╠═
╡Bus 72009 68 km
║
╠═══════Groningen══════
║
╠═╡10:44 Groningen Hoofdstation
╠═╡10:53 Corpus den Hoorn Zuid
╠═╡Bus 10
║
╚═════[
Groningen]════
Stats:
Time Interval Travelled
06:46 - 10:59
Total Time Travelled
04:13 h
Total Distance Travelled
307 km
Live Track my Journey
#NowTräwelling
[1] https://traewelling.de/status/3313315
[2] https://traewelling.de/status/3314373
Notes
06:45
The IC (train) by 
I'm traveling with has just announced, one minute before departure, that it will not be stopping in 8 out of the 11 stops. Leer (where I need to go), is one of the 8 stops my train will simply not go to. I will have to redo the entire plan for today, as the bus going to Groningen from Leer is only going once every two hours.
07:12
Apparently that's not the case?? We're stopping at one of the non-mentioned stops. I cannot comprehend why they would make a three minute announcement about what stops they take or don't take simply to then back down from this plan entirely a minute later. The German public transportation system is a mystery to everyone involved.
07:17
Fully confirmed that's not the case. They just wanted to give everyone on board a heart attack. I certainly didn't hallucinate them saying that they won't stop at Leer, especially because some people got up and left as a result of it.
07:53
Final meal eaten. Today is going to be a good day!
08:33
Just now watched the ZDF Magazin Royale from last week. Did not know they discussed multiple sclerosis there as well! Just to note, the preparation for this study, as well as my involvement, has been going on for multiple months. Would be hilarious if I saw that show and then decided to participate here, as they specifically discussed how behind research on the topic is. However, you cannot join medical studies that easily and quickly (luckily).
First time I've driven to the Netherlands for this study was on the 19th of April, and a lot more happened before then: https://mastodon.de/@ErikUden/112296568004356434
09:16
Just arrived in Leer (East Frisia) and am now waiting at the central bus station for the bus to Groningen! Despite my worries, I have arrived.
10:03
I just drove below the largest pedestrian bridge in Europe! Haha. There was also a nice lake next to it.
10:23
I have just been informed in German with a Dutch accent that we will be driving through a new tunnel for the first time in the history of this bus route!
10:27
Arrived in Groningen. This place has become my second home! Let's hope it stays that way.
10:42
Inside the Bus, now going to the research facility. I should be there about an hour in advance, just how I planned.
11:06
Arrived at the ICON facility at Van Swietenlaan 6, 9728 NZ Groningen, Netherlands. Since my official arrival time was 12:00, I'll have to wait a bit. However, this is much better than being late.
11:24
An assistant came and guided me through everything. My weight was measured, three blood samples were taken, and my wellbeing was checked.
Picture of my last meal before the study. Starting 4 hours before my screening at arrival (12:00), I am not allowed to eat anything, nor drink sugary / caffeine based beverages. For other studies it's sometimes 8 hours or more, so this is pretty mild and I can even have a breakfast the same day.
For the past 6 months I was not allowed to do weed.
For the past 2 weeks I was not allowed to eat poppy seeds.
For the past 48 hours I was not allowed to drink alcohol
In 24 minutes I am no longer allowed to eat anything.
My fast begins soon. I wish a nice breakfast to everyone!
Day 001 of the Multiple Sklerosis Study
(Compound Day -3) Tuesday on 2024-09-03
Groningen, Netherlands (GMT+1)
I just arrived at the ICON medical research center in Groningen today at around 11:00 AM! As I was an hour too early, I expected to wait longer, however, the staff was very glad about someone arriving early, as not only was I the first to arrive, but also could they prepare all the things for me that later might take longer due to having to do it for more people. At around 11:26 I was given a wristband that can identify me. It shows my name (Erik Uden), PRA Number (0H1W3G), group (1-2b1), and my V number (0056). After that I was shown around, shown my room, shown the beautiful and fun recreation rooms (we have like three separate living rooms with fusball / kicker tables, dart boards, TVs with Netflix etc. on them, and much more).
My blood was taken for three samples, my weight measured, a urine sample was taken too. My mental and physical wellbeing was checked.
At 12:02 I was given a schedule for the coming three weeks, and an emergency wristband was put onto my other arm. I can press it which will alert staff, and if I take it off staff is alerted. So I have to wear it during shower etc.
My schedule for today
12:00 Subject check in
- Urine clinical chemistry
- Body weight
- Blood libal chemistry
- Wellbeing
- Study briefing
12:30 Lunch
14:00 Physician task
- Physical examination (abbreviated)
- Neurological examination
- Brief Psychiatric Rating Scale
- Cannabis Withdrawal Scale
- C-SSRS
15:30 Afternoon snack
17:00 Wellbeing
18:30 Dinner
21:00 Evening snack
I still didn't have the study briefing. I was told it'd gonna happen ~15:30 and was rescheduled.
At around 12:12 I was already done with everything due to being so early, hence I could already go and eat lunch. I did not understand that the Dutch have their main meal in the evening, hence I was a bit disappointed at first. Although the food offered is more than enough, it didn't seem like a full meal. Later, however, I was allowed to choose my dinner for the coming weeks, then I realized when the Dutch have their heavy course.
I had tomato soup, three slices of bread (with cheese, hummus, tomatoes, cucumbers, de ruijter sprinkles, and abrikoos/bosbes fruitbeleg as topping). I drank roiboos tea and milk. There was no limit on how much you could eat, I could've eaten more, but wasn't too hungry. They also have a machine similar to that in Subway to make toast even with cheese etc. on it. That was pretty cool.
During lunch I recall a man loudly proclaiming “spaghetti!” upon seeing the tomato soup. We did not have spaghetti. He did not seem disappointed, however.
I was told that the breakfast is fairly similar with the difference being that you also get Yoghurt.
Around 12:40 I was done with lunch and called my family to inform them that I'm fine and all is going well.
After around 8 minutes, however, I had to abruptly end that conversation in order to participate in a tour of the whole facility, or rather the spaces we're allowed to walk in. I can go in one large circle and don't just have to stay in my part of the clinic. I can even go onto a balcony and breathe fresh air, sometimes there are (guided) tours outside. What is very clear, though, is that we are not allowed to go outside on our own for the entirety of the study. I can have visitors, but for the next 19 days I have to remain on this clinic, hence the many recreation rooms.
I had my physical examination exactly at 14:00. Everything was fine.
Stats of today
Water intake: 3 (glasses)
I've been given the study briefing at 15:12 and a ton of information I'd wish to share. Most importantly that my first lumbar puncture is tomorrow Morning 08:00 AM, and that there is no reserve for this group, so unless we drop out or our blood tests yield bad results, we're all going for this ride.
Regardless, it's 22:35 as I'm writing this. I'm going to bed!
Also to note: my perception of time is completely gone. I feel like I've been here for days already, I just arrived this morning. I did not take any of the compound yet. This is just a general vibe I have in such facilities.
@ErikUden (weich) (aber nicht saftig)
@GreenSkyOverMe Du suchst mich heim in meinem eigenen Zuhause, nur um so einen Disrespekt aufzuweisen. Hier ein Video davon wie ein guter Pfirsich klingen soll:
@GreenSkyOverMe das ist ja nicht auszuhalten!
@ErikUden Sie könnten bei der Studie ja gleich mal mit analysieren, wie es zu Störungen bei den Pfirsichknackigkeitspräferenzen kommt
@GreenSkyOverMe @ErikUden so gehört das. Nur so entfaltet sich der volle Geschmack.