Ceftriaxone Question

kevinw · 11-05-2008, 02:37 PM

Has anyone had any experience with the Ceftriaxone Trial? I was looking into enrolling in January, from my understanding it will last at least "one" year and it is given by IV. But, it appears from my research on the web that this goes back to at least 2006 and I have not found anything that proves to me that it might be effective in protecting motor neurons. Any input or advise would be great.

Thank You,
Kevin

Al · 11-05-2008, 03:20 PM

Last I heard was that this was on hold while they did the lithium trial.

AL.

ilgal · 11-05-2008, 03:24 PM

I was in Ceftriaxone stage I and II from 10/07 til 10/08 at Washington U in St. Louis. They told me with the data from I & II they expect to start phase III soon, but I dropped out. I decided it was too much hassle--twice daily infusions, a lot of time for my husband who now has to do so many other things for me, monthly visits to St. L which is 75 miles away, problems showering, couldn't wear certain clothing because line and dressing show, problems traveling with all the supplies, etc , etc. It wasn't helping me (my funtional rating score went from mid-40's to 26 over that time period and FVC declined), but I may have been getting the placebo. I did my bit for science and I'm done. Good luck to you if you sign on. If you have any specific questions just ask.

Jennifer51 · 11-06-2008, 07:25 AM

The MND assoc UK has just sent me news of the proposed UK lithium trial...cos I have been driving them mad for information, but in any case I think it has been announced in the press now..there will be approx 200 participants from 10 centres around the uk...dont know which yet...and half will get the placebo, computer chosen. It will run in parallel with the north american trial. Duration of the uk trial 18 months.
you must have a diagnosis between 6 months and 3 years, and it is ALS...and they want similar forms...will that rule out bulbar onset...dont know... must have been taking Riluzole for at least 4 weeks....forced ari capacity of 60%, be over 18
no one with gastrostomy, no one with tracheostomy or non invasive ventilation..no one with any medical condition that may pose a risk...(maybe that will let me out of it, as I have suffered with kidney problems since age 16....). No one can participaate if they have had entry to another trial within the entry to the study. Hope this is valuable to others in the uk. They say to talk to your neuro about it if you are interested.

THEN on the news this morning...BBC world news, which I heard in Florida.
STEM CELL....sorry it was 4 am, so I didnt get all of it...I think it was in Japan, they have managed to make a brain, or part of one, from ...was it cord blood?...I think they said stage one, two and 3 of the brain...apparently there are 5 stages.?...so work is coming on there...I have tried to find a link to some REAL information about this but failed.
jennifer51

kevinw · 11-06-2008, 09:11 AM

Thank You for your replies.

Al, you maybe correct in that delay. Because my doctor had told me about the study in the early summer and it was supposed to start in the fall. Then when I questioned it, I was told it was going to start until January (so it seems it keeps getting bumped back for some reason).

Igal, that's what I was thinking it might be like (a lot of work & time). It's going to be a busy year coming with my daughter graduating and picking a college to start in the fall. So it could make things a lot more difficult if they have the study.

Jennifer51, good information on the lithium trial. It really makes it hard to know what (if any) trial I should enter in. I would really hate to go thru a year of hassle if I were only on the placibo and didn't know it.

ilgal · 11-07-2008, 04:19 PM

By the way, when I was in ceftriaxone trial I started taking lithium and they didn't make me quit. I know another woman who did also. Researchers said they didn't know yet if taking lithium would be allowed in Phase III ceftriaone.

rutha · 11-21-2008, 05:21 AM

Hi ilgal - my brother wants to start taking ceftriaxone. Could you tell me the dosage that was used in the ceftriaxone trial. Also, was any other medication given with it such as Atovaquone or Mefloquine? And was any medication given to prevent side effects ( eg colestyramine to prevent gallstone build up)
Thanks a mil, rutha

KinzaDAF · 08-27-2009, 11:22 AM

My father is trying to decide whether to take part in a Ceftriaxone trial. He will be seeing a Dr. at The Ohio State University on September 1st and will be getting more information. From my understanding of things, not only will OSU be doing a tril with this drug, but so will the Cleveland Clinic ( in Ohio ). It sounds like there is a lot of hassle involved with the trial for this drug. My parents are trying to weigh the pros and cons. If he gets the placebo ( and presumably can't take other, helpful medications during the trial?? ), it may be worse to participate than not to ( and be able to take other things that might be helpful ), but if he *does get the Ceftriaxone, maybe it will *help him. What benefit is it exactly, that they hope will *come from this drug?

Debbie

serenade · 08-27-2009, 01:53 PM

Hi Debbie,

I will be involved in the Ceftriaxone trial starting in September. ( It has been a long wait for this trial to start) This is what information that I have. My doctor thinks the Ceftriaxone has promising results in slowing down or halting ALS. There are medications that you are permitted to be on (rilutek is ok)(lithium is not) but you must be on them 30 days prior to receiving Ceftriaxone. You must remain on the medication through out the trial. There is a screening process to be approved for the trial, it takes about 30 days so any medication they do not want you on can flush out over the 30 days. I take no medications for ALS only herbal and some for sleeping and twitches. As one of my doctors stated to me it is not likely to stop the ALS but my participation will have benefit for others with ALS. In the trial you have a 67% chance of Ceftriaxone and 33% chance of the placebo. The medication is given daily by an IV port. I am doing it because I have nothing to lose but maybe something to gain for myself or others.

Good luck with making your decision. Send me a message if you would like me to keep you updated with any information I receive

Judy

t34gib · 08-27-2009, 10:47 PM

I am going for screening at the Mayo Clinic in Jacksonville on September 8th. My doctor also thinks it is promising. I agreewith Judy that any help I can be is worth it even if I get the placebo as it may help someone else down the line. Also, presently I only have bulbar symptoms and I am very mobile so even though it seems like a hassle, it is doable. I think it will become just a part of my routine. Everyone has to make their own decision based on their circumstances.
NancyS

KinzaDAF · 08-28-2009, 11:01 AM

Thank you. Right now, my dad is only taking one medication ( I can't remember what the name is at the moment. ) and that is for controling his emotional ( tearful ) outbursts. I know my parents are wondering about what else, if anything, Dad would be able to take if he decides to participate in the trial, especially since there is always the chance he will be given the placebo.

Debbie

RoadKill · 09-20-2009, 04:34 PM

I would like to know if it is absolutely necessary to have a caregiver do the administering of the drug and flushing of the line or if it is possible to do with one good and one not so good arms/hands.

Has anyone got experience with this (phase II) or this sort of thing?

tdamess · 09-20-2009, 10:06 PM

i don't even know why they have a placebo it is not like you can cure or stop regression of als...all they really need to see if and how many get better.... and what other meds other people take and who don't . and try it on the ones who dont take others. you may need a combo and dont know it or the other way around maybe just the one will do it

Zaphoon · 09-20-2009, 11:55 PM

TDAMESS,

My sentiments exactly! What in the world do they need a placebo for? Why not just get as many in as possible and load up with the new stuff. If it works, great! Heck, we already know the placebo isn't going to work. Right?

Placebos are just mean when it comes to giving them to people with diseases that already have no cure. Give me something that has a chance to work (my logic, anyway...).

Zaphoon

Al · 09-21-2009, 01:27 PM

They won't even let me in the trial to take the chance of getting the placebo. Been dx. too long they say. Gotta like that. Good news bad news sort of thing.

AL.