Arimoclomol Phase IIb Trial Upcoming

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ZenArcher

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I was in clinic yesterday 11/7 and was informed and the beginning paperwork for Arimoclomol Phase IIb is in process at Hershey Medical Center. I was told that the trial would more than likely begin by the first part of the new year at the latest. This is of course dependent on FDA and individual testing center sign-offs.
 

brooksea

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Arimoclomol trial at Emory

At Clinic yesterday, research nurse indicated Arimoclomol trial would probably begin around March at Emory.
 

patricia1

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I was told by my neuro on tuesday of last week that I could be on the list for the trial in Jan 08 I am soooooo excited .Hope I get in the trial of only 20 in my clinic There a criterias like you cant have ALS for more then 5 years and you cant be on a vent are someI hae symptoms 8 years but diagnosed only 3 years so I have my fingers crossed Pat
 

patricia1

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Thats no my understanding. I go to drexal in Pa Ill get back to everyone when I find out more.
 

mamaoftwo

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Am I missing something here. Where is the exciting benefit to a drug that may extend your life expectancy by 5 weeks? There must be more to this?:confused:
 

patricia1

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I START THE DRUG ON THURS i STILL DONT KNOW WHY ITS NOT ALL OVER THE NEWS I HEAR IT IS VERY PROMISING, BUT I DONT HHE ANY REAL RESULTS OF THE TRIAL. I AM IN THIRD PHASE OF IT AT DREXEL IN PA. I AM VERY EXCITED BUT DONT GET MUCH INFO ON IF IT WORKS. PAT
 

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I am hopeing it works, Pat. You deserve a break! Cindy
 

patricia1

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Remember Guys if it works for me it will work for all!:mrgreen: FINGERS CROSSED
 

ZenArcher

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I did some research. I knew that a Phase IIa trial had already been done to test dosage tolerance and wondered is they had measured anything else. I then found that they had let PALS who had completed that trial take the drug for an additional 6 months. Now take into account that this is not from a controlled study and is published by the drug manufacturer so take it for what its worth:

Several markers of disease progression were followed throughout the open-label extension clinical trial, including the ALSFRS-R, vital capacity, total body weight and body mass index (a measure of obesity). In the absence of placebo control, CytRx chose to compare the open-label clinical trial results with the placebo group of a recently-published clinical trial (Cudkowicz, M.E., et. al., Annals of Neurology 2006 volume 60:22-31) that enrolled patients with very similar characteristics. While difficult to draw definitive conclusions without a concurrent placebo control group, there was an apparent trend toward a slower decline in every disease progression marker in the arimoclomol open-label clinical trial compared with the historical placebo control. In the trial, CytRx observed a decrease in the rate of decline of 21% for ALSFRS-R, 8.0% for vital capacity, 23% for total body weight and 20% for body mass index when compared with that historical control.

http://www.bio-medicine.org/medicine-technology/CytRx-Reports-Promising-Data-from-Its-Open-Label-Extension-Clinical-0ATrial-of-Arimoclomol-in-ALS-180-1/
 

patricia1

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Thats not very incouraging Maybe I shouldnt bother Pat
 

ZenArcher

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Based on current estimates that means that it would slow progression approximately 8 - 13 months. That's better than the estimates for Rilutek. I don't know about you but if I can remain self-sufficient for an extra year I'd be happy, every little bit counts. The thing to remember though is that those numbers came from an uncontrolled study and the data was reviewed and published by the manufacturer. The data from this study will be what we really need to see.
 

rgovardh

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Dear All,

I have my elder brother who has been diagnosed for MND in 2005. He lives in India. Can I please know if I can put for this clinical trial ?

Thanks a lot for your help.

Kind Regards
Rama
 

ZenArcher

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The FDA stopped this trial for reasons which have not yet been made public. Additionally as far as I know the trial would be done in the U.S. If I were you I would look into lithium. There is more information available on the web but the links are no longer allowed to be posted here, simply do a search on Google for "lithium ALS".
 

patricia1

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Dear All,

I have my elder brother who has been diagnosed for MND in 2005. He lives in India. Can I please know if I can put for this clinical trial ?

Thanks a lot for your help.

Kind Regards
Rama

I have been getting a run around by my neuro in regard to this trial. I was supposed to have stated in Feb. The thing that makes me wonder is What ever happened to the first trial of 200 people Did they improve and if they did and had no side effects whats the delay. My thoughts is there was no improvements or we would have heard by now.

The same with lithium Who has heard anything real positive except movement in two fingers I am so disappointed . Pat1
 
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