Hello Everyone.

Any news on when the trial will be completed?

Give me all the news. I need some positive energy.

Regards.

Kip Jones
Ontario, Canada

The U.S. trial still has a handful of people to enroll so once that happens it will take another four months for the trial to be over.

4 months hey? Holy $#%$%#@$#@$#@$#@$. Seems like an eternity.

I am not sure where we stand up here.

I am in talks with the trial doctor through faxing and have not received an update as of yet.

He tells me that if the FDA in the US goes for it, then we are more than likely to follow.

I was told that our doctor may not even be privy to the type of drug she was on and we will know only when the trial is over.

Kip Jones
Ontario, Canada

The US trial, and the canadian one, are not separate trials, it is actually a north american trial, and hope4fully the trial can be completed soon. Canada and the US are not doing the same trial, side by side, but separate. It is one trial. The number of people needed to complete this trial can come from the US or canada, because it is one north american trial.



Edited 1 time(s). Last edit at 04/12/2010 04:02PM by Barb.

You are right, Barb!

lol I used to think they were separate too marsha. So good to have US and canada working together on this, although we don't have as many trial sites as the US has. But together i hope this ends soon.

FYI: The HART doctor at UTSWMC was anticipating an open label (ACR16) follow-on trial. On 5/13/10 the MPH (Master of Public Health) working with me advised the HART doctor that any Medical Doctor would be able to prescribe ACR16 after submitting appropriate paper work.
Maggie, the MPH remembered you and your husband.
I discussed 'Compassion-use' and your ground-breaking work with the FDA and Neurosearch. Bob

NeuroSearch is working on a distributor contract in the U.S now. Then we can apply to the FDA for expanded access.

Was Amit the MPH? How did you do during the trial?

Maggie, Amit was the MPH; Dr O' was the MD. My final visit is next week. Bob

Does this mean that it is in the works for ACR16 to be available to everyone regardless of whether or not you participated in the trial? My husband was just about to start the trial and the psychiatrist (at the Huntington's clinic we are associated with) knew nothing about ACR16 and recommended a med on the exclusion list and we took his advice. My husband had a horrible reaction to that drug and was consequently put on another drug on the excluded list - now I am so frustrated that things went this way... But, if the drug became available to everyone soon it would be so wonderful! Any timeline?

The owner of the drug, NeuroSearch, is working to get ?expanded access? approved for those pHDs who participated in the trial. It will not be available to everyone until after full approval by the FDA. At this time they are working to get a contract signed with a US company so that they can legally send the drug across state lines. If you do a search under my name or ACR16 you will find the last email that I got from NeuroSearch explaining this. At this time they do not know how long it will take.