Hi all-

LaVonne Goodman has written an important article entitled "Why We Should Bother with ACR16" about participation in clinical research generally and, in particular, the currently enrolling trial of a drug called ACR16 being conducted by a company called Neurosearch and the Huntington Study Group.

You can read the article here: "[hddw-dev.host45.com];

Some people have expressed concern that this is a "new" potential drug and people, even scientists, might not know to much about it or its side effects. Elsewhere LaVonne has written:

"Wouldn't this drug be great?

"Published In 1999 journal of Neurology; There was an HD person who for the previous 2 years could no longer feed herself or drink without spilling. She had moderate chorea (about 40 chorea movements every minute) and suffered falls about twice a week. She volunteered to take an experimental drug: OSU6162. After one dose her chorea decreased from 40 to 2 movements every minute. And she could feed herself and drink without spilling, and she didn't fall for the duration of the study. And all this with minimal transient side effects.

"IT sounds almost too good to be true. But wouldn't a drug like this
be great?

"Well . . right now, a whole 10 years later we finally DO have a chance to try this same kind of drug in the improved 2009 version. This drug is ACR16 now in clinical trial in 17 centers over North America.

"And it's not just for chorea. In an earlier short trial (in Europe) it appeared to broadly improve symptoms: motor (chorea and dystonia), emotional (improved depression and decreased anxiety) and improved measures of cognition. AND had no more side effects than placebo.

"My opinion: We should be running - not walking - to sign up for
this one. If it turns out to be as good as the first one looked, we'll
finally get a very good drug for Huntington's.

Information about how to get involved in this study can be found on the Huntington Study Group website: "[www.huntington-study-group.org];

If you or someone you know might be eligible to participate in this trial - make the call and find out more.

I would also like to learn more about what people on this list think about participating in clinical studies. What issues are important to you? What would you like to know more about before you decide to take the next step and call to see if a trial is right for you? What prevents you from participating? And anything else you care to say about the topic! Please feel free to respond.

Thanks for your help. You can make a big difference.

Robi
CHDI Management/CHDI Foundation

Robi Blumenstein
CHDI Management/CHDI Foundation
robi.blumenstein@chdifoundation.org
www.chdifoundation.org

Robi,

I'm gene positive, CAG 40, with no symptoms at age 62. Just last week I was talking about this with Dr. Walker and Christine O'Neil at Wake Forest. My wife (control) and I are both in the COHORT study and were there for our annual visit.

I would be willing to participate in any study that would allow me to stay with the exercise and supplement routines that I believe are helping keep me symptom free. I'm sure there are many more like me. That might give you some guidance for clinical trial design.

Will Brown
Raleigh, NC

Robi,
As a caregiver I have concerns about taking my PHD off other medications in order to participate in this trial. My PHD has pretty severe depression issues and it's pretty well managed on Cymbalta at the moment. Would my PHD be required to stop other medications?

We are also 3 hours from the nearest COE and that trip in and of itself would be stressful. I'm hoping the facility we go to now will become a COE in the future. How often does the PHD have to visit the COE?

One other concern, what happens when the trial is over? How long is the wait between the final clinical trial and FDA approval of the drug? If the drug works well, I'd be worried about my PHD's depression returning even worse if he was forced to stop this treatment.

It certianly is something to consider and thanks for your information. I will read the link you posted.

Chris

Robi,

My pHD husband has been involved in 3 clinical trials at UCSD. He was involved with the Tetrabenazine clinical trial. Every since then he has continued to be on tetrabenazine and has done well taking it. We know that UCSD is one of the sites for the ACR16 clinical trial. He has volunterred to be on the ACR16 clinical trial , but has been turned down because he is taking pAxil and tetrabenazine these medications are on exclusion list.

As a caregiver I would not want him to stop his current medication, it is to great a risk for him and to me. Also with this clinical trial he may be on the placebo, which would be fine if he could continue his current medications.

My husband and I both feel his involvement with the clinical trials has been beneficial to him and the HD community. Best of luck with the ACR16 recruitment.

Debra



Edited 4 time(s). Last edit at 03/02/2009 10:03AM by Debra.

Robi- My daughter would love to be in any clinical trial. We have tried to get in many of them but are always told that she is too young. She is 26 years old. I think it's a shame that she is denied the chance to participate and the hope that goes with it.

Robi, what's most important for me is me. I have never done a trial yet. I would consider one if i thought it would be of benefit to me, and i knew and understood the possible side effects of the drug. This acr16, i have no idea what it is or what the sife effects could be. I just will not do that to myself, never. When it comes to me and hd, i come first, not what i can do for others. That may sound selfish, but that is the way it has to be. I easly get side effects from dif meds. I need both me and my doctor, if i am put on a med, and i get side effects, to be able to adjust the dose according to my needs. That cannot be done in a trial. I am doing well, my hd has improved so much from my memantine, and i do not want to mess with the unknown. When it comes to me, i have to be in control, i have to know all possible side effects, so i can make an informed decision for me and my health. I just absolutely will not do a trial, unless it shows absolutely that i really really might have good benefit from it, and not a bad reaction to the med. If i was not already on memantine, then i would for sure want to go in the memantine trial, it is a med that has already been proven in alzheimers disease, i can look at the possibe benefits and risks, and make an informed decision. I cannot make an informed decision about acr16, because there is not enought information about it, and i just will not under any circumstances do that to me.



Edited 1 time(s). Last edit at 03/02/2009 07:36PM by Barb.

Howard, i just did some reading, and Allison has to be age 30 or over to go in the trial.

She's always about 3 years too young no matter what the trial is, Barb. Obviously, young people don't matter to the people doing the research. I really feel that way having talked to people in charge of these trials in the past. Not one has ever had the courtesy of getting back to me about making an exception despite promises to do so. Her own neurologist has run trials, suggested she participate, and been unaware of age limitations. I've really lost respect for the humane abilities of the people running these trials. It's obviously only a numbers game to them.

The second link here Howard is where i found the age qualifications. It turns out i wouldn't be able to do this trial too, even if i wanted to, but i don't want to, but i can't do it anyways because i am on a mood stabilizer. Sorry for your frustration Howard.

[hddrugworks.org]

[clinicaltrials.gov]