Here we go – another stage
Last week on Wednesday I received the mail that Biohaven considers me suitable to participate in the study.
As final start date we had agreed on the 23.07.20. So I am the last of our happy WhatsApp group to start the study, with a delay of 4 months. What was partly due to Corona, but also to Germany and its strict regulations. In addition, Biohaven gave the participating research institutes only 2 weeks time to recruit. When I heard that, I was glad that I finally got in.
Biohaven was the first study that Marta and I found.
Yesterday the University of Düsseldorf called me and invited me to come and meet them and see if I was suitable to participate in one of their studies. A) a follow-up study and B)BIIB101 from Biogen. It would consist of having RNA fragments synthesized via lumbar puncture antisense alpha-synuclein oligonucleotides.
However, it is not allowed to participate in 2 drug studies at the same time.
8:30 a.m. on a Thursday somewhere in Berrendorf/Wüllenrath a small red car is loaded as if it was going on holiday, and the new walker came with it, including the seat part.
The traffic was quiet, Marion too!
After the arrival we started directly, with blood taking, physical examination, EKG, surveys and questionnaires I was very busy. My sister (study companion) also got 2 questionnaires to fill out before she went with my nephew to Haribo, Lindt and Poldis Dönnerladen.
What I was not aware of: the “sponsor” prescribes everything from the ECG electrodes to the order in which the blood samples are to be taken. The employees of the DZNE have to have who knows how many user passports because all equipment is provided by the sponsor. Apart from the MRI! This ensures that everyone can complete the study under the same conditions.
While the two of them enjoyed local “specialties”, I had a lumbar puncture with Dr.G-E and Mrs. E on the agenda. All the information I received seemed so familiar, except that I was standing in front of the bed and not sitting on it. But that was in another life.
The puncture was unpleasant to bad, so I would prefer a local one next time. The lumbar puncture is part of an optional study, where on the one hand the concentration of the drugs in the liquor and on the other hand they also examine the proteins and why they are deposited there of all places.
After a successful puncture, the patient should lie still and drink a lot.
And then came the moment to take the tablets! In lateral position like in the morning at 6.00 o’clock. Somehow I had imagined it to be more spectacular. I don’t know, only that I had to stay there for another 4 hours for observation !
There was information on the net that the drug would be available for 48 weeks after the study. So the right one not the placebo.
Mrs. E. said it would be different from country to country, but there is the possibility that the sponsor would continue for 48 weeks and no one would take the placebo anymore, but all would take the drug. But it depends on the results and the “sponsor”!
Now we have to wait and see!