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Al

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A Randomized Clinical Trial of Lithium Carbonate with Riluzole
Versus Placebo with Riluzole in ALS Shows No Benefit

In February 2008, Dr. Francesco Fornai and colleagues at the University of Pisa, Italy, reported in a pilot study that lithium carbonate at dosages of 300-450 mg daily (titrated to a plasma level of 0.4-0.8 mEq/liter) combined with riluzole showed a large positive effect in people with ALS (Fornai, F., et al., Lithium delays progression of amyotrophic lateral sclerosis. PNAS, 2008.105(6): p. 2052-2057).

To further investigate lithium carbonate as a possible treatment for ALS, a randomized, blinded, multicenter trial of lithium carbonate with riluzole versus placebo with riluzole was conducted in people with ALS in the U.S. and Canada. The study used similar dosing to the Italian study. The study was conducted by the Northeast ALS (NEALS) and Canadian ALS (CALS) Consortia and was sponsored by the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health, The ALS Association and the ALS Society of Canada. This unique collaboration between investigators and funding organizations resulted in a novel study design and expeditious execution of the trial to efficiently answer a critically important clinical question. Study leaders included Drs. Swati Aggarwal, Lorne Zinman, Jeremy Shefner and Merit Cudkowicz.

An interim analysis was conducted after enrollment of the 84th subject and presented to the NINDS Data and Safety Monitoring Board in September 2009. Based on the interim analysis the trial was stopped for futility. This study did not show the same beneficial effect of lithium carbonate on the progression of ALS as the prior pilot study conducted in Italy.

Although the results are disappointing, it was very important for the ALS community to quickly and efficiently determine if the large benefit first observed for lithium could be replicated in a well controlled trial. With the ongoing assistance and commitment of patient volunteers, researchers can now focus on other promising therapeutics for patients with ALS.



In the past decade, The ALS Association has awarded $48 million to fund research to find the causes and a cure for ALS. Learn more about The Association’s research and grant programs along with the groundbreaking TREAT ALS initiative at ALS Research News - The ALS Association.

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Reprinted with the permission of the ALS Association from the ALSA Research Update.
 
I knew that before they ever started the trial. Unfortunately they were a way behind the rest of the world. I was in a study 1 year before they ever started and the results were that it did not work. What a waste of money and time. To bad they were not paying attention.
 
This was not a good drug for Glen .Glad we stopped it early.
 
I'm glad we never di it!
 
Wanda-

I understand; I'm sorry.
We go on from here.
 
Too bad, but not a surprise. I'm actually still on Lithium. I just never stopped, as it isn't causing me any problems. Clinging to threads of hope.

Does anyone know if there are any Lithium trials still going on? If not, I guess I'll taper off the Lithium. I think there's some interaction with Synthroid, so I need to do so carefully so I don't throw my thyroid out of whack.

Thanks,
Tom
 
Lithium is deadly for a persons thyroid. Be careful.
 
can this topic be moved to the research/drug study catagory? then we could all promise never to discuss Lithium again :) new people could find the thread & not waste any time with it either. I try to keep hope but this isnt it.
 
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lithium affects thyroid , so if you stop lithium check thyroid levels 6=8 weeks after as you may need to lower thyroid med . i would check it if you feel any thyroid symptoms comming on
 
No surprise about lithium. Serious concerns over the Italian study emerged not longer after they published their reports. The Italian researchers should be ashamed of themselves.
 
Thanks Joel and tmamess for the replies about the thyroid. Yeah I never had a thyroid problem until I started Lithium. Coincidence? Probably not.

Thanks Danijela for the link to the UK trial. I'll check it out.

-Tom
 
incidentally, the UK have very few clinical trials for MND... but lithium was one of them. good to see the powers that be backed a dud horse! :? although i suppose they've ALL bee duds, so there's no point complaining. here's hoping KNS brings some better results.

Massive, massive waste of time. What a disappointment.
 
tmasters- even if you did have a thyroid problem the lithium did affect it so, you just would of had to up thyroid med'sso, keep an eye on it over the nexy year after stopping lithium.....take care
 
I have been on lithium since 2/08. it hasnt done me any harm...yet. my progression hasn't drastically changed since then. maybe its a coincidence but i don't question it. i will stay on it
Erin
 
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