Trial for Oral Drug

Just a quick update that I went to meet with the MS Nurse today for the first time and she spent 2 hours with me allowing me to talk about my recent dx, treatment options and the drug trial that I have been invited to take part in.

To cut a long story short I have decided to do it and they have currently recruited 4 people and want 6 and my Consultant felt that I was an ideal candidate. I sense that there is a lot of wariness on the forum about oral drugs, reading some recent posts but I feel confident that I will be very carefully monitored throughout the trial and will receive excellent support and care.

In view of the fact that as far as I am aware only one other person on the forum has been on an oral drug trial, I am wondering what would be the most helpful way to share my journey with everyone. I am happy to post and let you know what each visit involves, and it may be that I do not make it onto the trial if the initial screening throws something up. I just know that I found it really interesting and helpful speaking to someone else about doing a drug trial and I will be able to give first hand experience which I am happy to share.

Let me know your thoughts as I think this could be of interest to a lot of people and the drug is very similar to fingolimod (not sure if I have spelt that right but never mind!) which I believe will be licensed soon (under a different name). I was not sure if there is a way of putting all my posts about drug trial together do that it produces a journal/diary at the end of the whole trial.

I wil also be eligible to carry on with oral drug (or start it if I am on the placebo for the trial) at the end of the 5 months.

Love Sarah x

PS I halved my dose of amitriptyline to 10mg and feel so much better and not nearly so tired in the day with brain fog and I feel happy! Have a great weekend you guys :)

[Audrey_M]

Sarah:

Darn! Between the time that I started writing this and proofed it, Lu posted first and hit on my key points. I am giving myself solace by telling myself that great minds think alike!

Jens suggestion about keeping a journal on your personal page seems to make the most sense. That way there is continuity and it won't get lost in other posts to the forum.

It would be helpful if you know or can find out what percentage of participants in the trial will be getting a placebo and if they will tell you at the completion of the study whether you were getting the drug or a placebo. While you are participating in the trial, probably the most information that you will get from the study is on vital signs and the rest will be anecdotal on your part.

I salute you on your decision to participate in a clinical trial. My dad was an analytical research chemist for a major pharmceutical company and there were several times when I considered clinical trials. Phase III are the safest for participation and what you are doing may not only help you, but could also bring a very important medication to market to help others.

Back in the 1980's, I considered participating in a phase III trial for the birth control implant. My dad read all of the information published for the trial and had no reservations. I had previously had superificial blood clots and could no longer take the pill. I was a preliminary candidate for the trial, however it took them far longer to get the trial up and running so I dropped out.

Several years ago my son particpated in a clinical trial for Concerta, which is used to treat ADHD. We had regular biweekly visits where vital signs were measured, along with other tests and questions. While going through the trial, we did not know if he was on the medication or a placebo. I saw no significant improvement while he was on the medication and cannot remember if I followed up to find out whether he received the drug or a placebo.

Again, I salute you and wish you the best in your journey.

Audrey

[Wobbly]

Hi there.. I'm Dx, but not taking DMD at all, only meds for my symptoms as I'm SPMS and don't really understand that much about oral meds.  

I think doing trials is good to find answers and if your Dr tells you that you are a good candidate well, I would probably try it myself.  But then I'm not in that situation.

Do you feel they will keep track of everything and are you comfortable with that?  

you can post on here anytime to let us know how things are progressing and how you are feeling.  I am curious as too how your appt will go.  

How long is this trial??  are you Dx with RRMS?  how long have you been Dx?

you could add information on your Log for people to see. I can't remember the name of it..
let us know how things go.
take care and glad your feeling better.  
wobbly

[jensequitur]

Gilenia, right?

What they tell everybody is if you're going to try an experimental drug/procedure, do it in a clinical trial, so there will be testing and monitoring.  So you're doing the right thing!

I would keep a journal so people can go to your space and read, and also post to the forum, so that people that aren't keeping track can catch up.

Good luck!  I'll be interested to know what you find out.

[Lulu54]

I agree with Jen - the journal would be a great way to chronicle your experiences.  

Drug trials are very important, and all of us are indebted to the people who are willing to participate in them..... without people like you,  no drugs would ever get approved for human use.

Good luck with this and please keep us informed.  

my best,
Lulu

[Audrey_M]

Sarah:

Darn! Between the time that I started writing this and proofed it, Lu posted first and hit on my key points. I am giving myself solace by telling myself that great minds think alike!

Jens suggestion about keeping a journal on your personal page seems to make the most sense. That way there is continuity and it won't get lost in other posts to the forum.

It would be helpful if you know or can find out what percentage of participants in the trial will be getting a placebo and if they will tell you at the completion of the study whether you were getting the drug or a placebo. While you are participating in the trial, probably the most information that you will get from the study is on vital signs and the rest will be anecdotal on your part.

I salute you on your decision to participate in a clinical trial. My dad was an analytical research chemist for a major pharmceutical company and there were several times when I considered clinical trials. Phase III are the safest for participation and what you are doing may not only help you, but could also bring a very important medication to market to help others.

Back in the 1980's, I considered participating in a phase III trial for the birth control implant. My dad read all of the information published for the trial and had no reservations. I had previously had superificial blood clots and could no longer take the pill. I was a preliminary candidate for the trial, however it took them far longer to get the trial up and running so I dropped out.

Several years ago my son particpated in a clinical trial for Concerta, which is used to treat ADHD. We had regular biweekly visits where vital signs were measured, along with other tests and questions. While going through the trial, we did not know if he was on the medication or a placebo. I saw no significant improvement while he was on the medication and cannot remember if I followed up to find out whether he received the drug or a placebo.

Again, I salute you and wish you the best in your journey.

Audrey

[HVAC]

Good for you!  Good luck to you.

I would do the the Fingolimid trial at Duke if I could. The MS Specialist says my PPMS is not dramatic enough. They want people they can see marked improvement.

I am sure it will be safe and you will be well monitored.

My only comment on them is folks think they are basically the current CRABs in pill form. The CRABs are 30% effective at slowing the Progression of RMMS but very safe. These oral drugs will be 50%, 60% or more affective with that increase in effectiveness comes more suppression of the immune system and more problems. They will not be as bad as Tysabri.

Alex

[Sparkysarah]

Thanks for support and comments and I have started my journal giving some outline info about the drug trial so hope this answers your questions and watch this space for futher information. It will be a few weeks before there is anything else to report.

[Mand125]

Hi Sarah

I look forward to reading your journal updates.

Good luck with the trial, like Lulu says if it weren't for people like you drugs would never get approved.

I am glad that you are not feeling so tired.

Mand