particapents of hp184 [Archive]

ValerieD

08-13-2005, 09:18 AM

Midnight

Here's the problem. You might be on the placebo. I couldn't have been. The very first thing that came back, almost right away, was the sensation of hunger, something that had been gone for so long, i had forgotten all about it! By the 3rd month, I had regained 70% skin sensation, and my left side, the weakest from the beginning, began to awaken, and most significantly, my left ankle, which would not move at all, by the end of the study had nearly the same range of motion and strength as my right. Bowel bladder began to change, although that was not conclusive, but I did have much more sensation and awareness in those areas, and i know that now, because it all went away. If I had stayed on the drug, I know I would have kept improving. It's a little like watching your kids grow up. Relatives come and say, "Johnny, how you've grown". When you see them every day, you really don't notice. But you sure do when it all goes away. Taking a shower is such a painful experience, and that went away, but now is back. So many small things, along with the big changes! Maybe you are on the drug and it doesn't work for everyone, or mabe you are on the placebo. Damn these drug trials!

Kathy Ingwersen

08-14-2005, 01:26 AM

Hi Valerie and everyone, have just finished week 15, have had quite significant improvements, previously horribly low blood pressure now normal, neuropathic pain has dissapeared from some areas, improvements in bladder/bowel control, have small movements in both feet and in one ankle, quite large movement in one thigh, also return of normal muscle movement in lower abdomen. Am not looking forward to end of trial and going back to how I was. My understanding is that we all go forward onto stage 3 in about a year and then remain on the drug until it comes on the market - bring it on!

donz

08-14-2005, 05:40 PM

I want on.. How should I go about
t4-complete 3 months post

ValerieD

08-17-2005, 06:24 PM

Kathy

A friend of mine was so outraged about my losing everything he contacted the local news channel here in Boston and they jumped on it, they were here in two days and aired my story first on the 5:30 news the same day. Apparently, because of the Parkinson's disease patients that have recently been on the news, they felt that this was a very similar situation, medication that really helps, and then is taken away. I contacted also Aventis and got the name of the clinical director of the HP184 study to see if I could continue until the drug gets on the market. Channel 5 contacted them as well, and Aventis acknowledged having received my email and said they were seriously considering allowing me to continue. If anyone is interested here is the story they ran.

http://www.thebostonchannel.com/video/4860090/detail.html

They sort of missed the point, thinking that my greatest issues was pain, and not realizing that the astounding improvement in mobility was the real breakthrough! But at least it got air time. My friend has contacted the NY Times and sent them the same link, as they are running a series on drug companies and the ethics surrounding drug studies.

Anyway, for those of you who are fortunate enough to be on the drug, be prepared for when it ends. Although I know you can never be. Every day now is worse than ever before, because I know there is a way to be better. I felt for the first time in 5 years. And now it is gone.

I would love to start a group of people to petition Aventis to make those who qualify for any phase, be able to continue. I know it works.

ValerieD

08-17-2005, 07:49 PM

Well, hi folks, it's me again. And today is what I used to call a "Kevorkian" day, except this time it's the real deal! Before I was in the HP184 trial, I knew where I was, and where I was was better than before. Like another guy on this site somewhere said, "after 9 months I thought I would be back on my bike again, but now 4 years later, never happen!", I always kept the faith that I would beat this thing. But I didn't after nearly 5 years, but I was better than before. I was a "walking" quad. Yeah, right, I could barely walk as fast as a turtle, but at least I was up, and I could exercise my body, although I used the wrong muscles to move my left leg, and that really hurts my back.

And then I'm offered the chance to try a drug that might help. OK! What have I got to lose? My sanity, that's what I had to lose. My God, I can't even begin to describe what the feeling is of being now 3 weeks off the drug. So many little things. So many, going away one at a time. Walking now is so hard, maybe no more difficult than it was before, but before, I never went backwards, I was going forward, slowly, but forward. And now, after having been able to pack 10 years of work into a scant 6 months, I'm back to the miserable state where I started, and the reality that unless I can take a drug like this, I am very unlikely to get any better. Since the end of the study, I have really studied up on what is going on here, and dead nerve cells are never, NEVER, coming back, until such time as the stem cell stuff is allowed and put into practice. The only thing we have is "jumper cables" in the meantime. And at least for me, HP184 was that!

For those of you out there that have some mobility, and have learned to cope with the pain, and those who have come to terms with your "inabilities", I warn you about the fall that will come if you are one of those that HP184 really works on. If you get a lot of stuff back, you will be astounded about all of the things you don't even notice come back, until it all goes away. Each of you, like me, has been going forward, and a giant leap forward with a sudden retreat is more profound and disturbing than you can even imagine. I really thought I was prepared for that eventuality, but I was not, and I don't think anyone in our situation can be.

Quad62

08-17-2005, 08:45 PM

Valerie, until you can get hp184, you can try 4-AP available from compounding pharmacies. It is also supposed to help with signal conduction in case of demyelination. Do a search on the forum for 4-AP. Goodluck. :)

ValerieD

08-17-2005, 10:18 PM

Quad62

Oh, I bet that's not your real name! I'm looking into 4-AP. Dr Young responded to an email I sent him to find out the similarities, and although they are different, i'm willing to try it. I think my Dr will proscribe it, and there is a compounding pharmacy in my town. You bet I'm gonna try it! I've also sent emails to ABC, and Oprah. I'm on a roll here. I'm not going to give up. A year ago I was pretty content with what I have, but not now! I know it can be better, and i want it! I'm mad as hell and I'm not going to take it anymore!

Oh by the way, I have a masters in Dance from Boston Conservatory.

I want to dance again!

shoc13

08-30-2005, 04:07 AM

How did you guys get into the trials?

Laurie O'Connell

09-07-2005, 09:29 PM

Hi ValerieD,

I'm glad to hear that you had such a positive experience with Sanofi-Aventis' HP184 test article (TA). However, I am even sorrier to hear about your current situation. Although I'm not personally SCI, my brother Shawn is and I would hate for him to have gone through what you have. With that being said, please understand that clinical studies can only be successful when people like yourself volunteer. I have written many informed consent forms for pharmaceutical companies and they always include a statement to the affect "this study can be terminated at any time without advance notice to you". That is primarily due to the fact that pharma wants to be able to stop a study when the risks out way the benefits to the subjects.

Please understand (and I mean absolutely no disrespect :) that the term "subject" is used rather than "patient". Although these terms are often incorrectly used interchangeably in the clinical research environment, the fact is that not all rights afforded to "patients" are the same as those of "subjects". This includes the right to continue treatment (test article) when involved in a clinical trials. However, even pharmaceutical companies must consider their ethical obligations to "subjects" who are participating in their clinical studies.

To conclude on an upper note, I have worked with both Sanofi and Aventis pharmaceutical companies prior to their merger and will contact either the Sr. Clinical Scientist or Medical Monitor of their Neurology Department by week's end to see if I can assist you in any way. Obviously I can make no promises, but I will definitely do what I can to advocate for you in your desire to continue receiving HP184. If allowed, please be ready to waive away all potential liability issues that may arise in the future (re: potential long term adverse events/side efffects of this test article). I think you have done a great job advocating for yourself and your needs :applaud: . Keep up the great job and good fight!! I shall respond by the weekend. Take care.

Laurie O'Connell

Tash

09-08-2005, 10:00 AM

Hi all

Sorry I don't have time to read the whole thread (new mum here) but has anyone expereinced any skin breakdown, or rash like behaviour that hasn't healed properly while on the trial? Would be interested in all answers.. or see thread "skin care" in the 'Care' forums.

Cheers :)

Laurie O'Connell

09-12-2005, 07:16 PM

Hi Valerie,

I'm sorry it has taken me so long to get back to you (between work and Katrina, I'm both emotionally and physically spent).

Please let me know if you are still interested in obtaining Sanofi-Aventis' HP184. If so, please provide me with the following information:

Your initials (it's what we in the industry call "subject's initials). These always include 3 symbols (e.g., ABC or A-B).
The indication of the study (was it pain??). If not, please specify.
Date you last received HP184 and at what location (Do you know the investigator's name? What was the site's name?)
This information will help in my communication with Sanofi-Aventis. Thanks and take care.

Laurie

ValerieD

09-16-2005, 11:25 AM

Dear Laurie,

I must confess that I have been remiss in checking this site. As you can imagine, it took me a while to get grounded back where I was but I seem to be getting back into the groove. I just saw your entry here and am thrilled that you are interested in helping me. I contacted Aventis and they turned me down, but what could it hurt to try again with your help. You have no idea how exciting this is.

Here is the information you requested.

Initials: VJD
Indication of the study: I hope I understand what you want here, my guess is you want to know what improved? I regained complete normal sensation over my entire body to soft and sharp. Prior to the study, I had, and now have about 10%
I regained normal motor function in my left side, most notably my left ankle which went from trace to 4. I regained full control over my left hand, now limited to three fingers. Nerve pain was significantly reduced and my trunk muscles awakened, although not soon enough before the end of the study to regain lost strength. In all, it seemed that almost every nerve pathway was working.

Last received: July 27th.

Investigator: Kevin O'connor
Site: Spaulding Rehabilitaion Hospital, Boston Massachusetts.

I hope this is the information you were looking for.

Thank you so much

Valerie D

Laurie O'Connell

09-17-2005, 12:30 AM

Hi Valerie,

I just now got back to my home office (it's approximately midnight Saturday am) so let me see what I can do next week. I don't want you to get your hopes up, but as you said (and please excuse my liberty to paraphrase), "what does it hurt to try again".

The information you provided me is all very helpful. The only thing that is preferable (but not necessary) is the indication for the study. What I am looking for is the reason the study was being conducted (was it for pain?, IDK). Any questions, pLease forward me a private email and I shall provide you my contact number.

As I just previously mentioned this information should not prevent me inquiring on your behalf. However, I hope you understand that I can only get so far (because of HIPPA regulations), but your all the information should provide a starting ground. I do not want to provide you with false hope. I may end up finding myself down a dead alley. Anyway it turns out, I promise you I shall give it 110%.

Take care Valerie. Best wishes for a peaceful weekend.

Laurie

ValerieD

09-19-2005, 09:53 AM

Dear Laurie

Now that I understand what you were asking for, the study was looking to improve motor function, skin sensation, reduction of muscle spasms and improved bowel bladder.

bambi

09-21-2005, 11:15 PM

Hi Dogger

So how did the 20 week evaluation go? (If nothing else, you will sure have clocked up some miles on this trial!!).

I'm 3 months in and some slight sensory changes. Nothing functionally significant. The very worrying sedation and tiredness seemed to dissipate after the first 2 months.

What has happened with you?

midnight, Sydney, Australia
Hi there im also from Sydney, Australia and would really want to know about this trial and where. My brother is C7-T1 incomplete

Tash

09-25-2005, 04:15 AM

Hi there im also from Sydney, Australia and would really want to know about this trial and where. My brother is C7-T1 incomplete

Talk to your brothers spinal care doctor or the local spinal unit.

Kathy Ingwersen

10-01-2005, 11:17 PM

Week 21 -something good happened - sort of went into overdrive - huge leap in energy and fitness - I could have swum for ever -don't feel like a quad anymore -haven't had a bladder accident now for 3 months - movement return more in the token range - little of any function but is was good anyhow to see my left foot and ankles move again, and my knee and how about those muscles in my lower abdomen - and now its all about to end - so in this game of snakes and ladders its back to the bottom of the snake for me

dgbharathi

10-08-2005, 11:03 AM

I am under the trial for the past four months. Till date i have not been given any details of notes, results, etc from the hospital. I would like to know what are the details I can obtain from the hospital.

Please kindly provide me the lists that I can ask from the hospital.

dogger

07-10-2006, 09:50 PM

Last year I was in the HP184 trial at PA Hospital , Brisbane , Qld , Australia . The trial has now been unblinded . There were 4 doses , 1) placebo , 2) 100mg , 3) 200mg and 4) 400mg .

I was on 200 mg and got back 8 points of function and 8 points of sensation [both of which I lost after the trial ended] on the ASIA scale . Most significant gains were my triceps , which went from grade 0 [a flicker in one arm] to 3 on both arms . I also felt my bowels and bladder were better behaved while in the trial .

Interestingly , it seems that the 200mg dose had the best results . Of the 6 [from memory] people in the trial at PA , I had the best returns , though one other was pretty much on par with me . I did have some side effects at the start and finish of the trial .

At the start I got a kind of buzzing feeling after taking the pills which wasn't a problem . At the end I fell into a heap for a couple of days [felt very tired] and had a few bowel accidents .

sister1959

08-05-2006, 07:54 PM

I am new to this site and have a sister who I love dearly C5-6. Is this study still going on? Have meds been approved? Where can I find out about studies?

Laurie O'Connell

08-06-2006, 05:39 AM

Hi Sister1959,

I am also not SCI but my closest brother (shoc13 or Shawn) fractured his C6-7 about 1.8 years ago. Feel free to check out his web site as it offers a wealth of information (www.shawnoconnell.com (http://www.shawnoconnell.com)). Care Cure also offers a Research Forum so you should check that out as well. You'll find people are VERY helpful and friendly. Finally, you can check out the web site clinicaltrials.org - but usually this web site (CC) has the most recent and usually accurate information.

I just informed another CC member via a PM last week that I just heard back from the Medical Director of Sanofi-Aventis (the pharmaceutical company that was conducting clinical trials with HP 184). He informed me that a Phase 3 protocol has been written but has been on hold for the past 4-5 months due to additional FDA-requested statistical analyses (and unfortunately they didn't obtain the efficacy data they were hoping for). Thus he strongly doubts that any further development of this compound will be initiated either in the near future or in the long run.

I know this is yet another "Hope for a Cure" failure, but it does pave way (and resources) for future more hopeful therapies/treatments. Just keep the hope and faith (or as my brother says: "Dare to Believe") that the Cure will happen (as it is just out of reach and just around the corner).

Sister1959, I wish you and your sister well. If there is anything you or your sister needs assistance with, just post (as this option alllows for a great number of opinions and experience from a great community) or feel free to forward me a private message. Take care Sisters.

(sorry, but the thumbs up icon was suppose to appear here, not prior to the subject). Oh well.

Laurie

Laurie O'Connell

08-06-2006, 05:23 PM

Hello all.

I am definitely sorry to all of those of you that were awaiting for a SERIOUS response to all of those many much anticipated, much deservered and well-awaiting responses to the these much and as yet much to unanswered-questions which were awaiting anticipated questions........................................

#1. Can't the Moderator mantain the current pulse of the members of ther CC community????? I know it's a difficicult job, so yes, I am offerring to stepin to assist as either a primary or a secondary alliangce.

At this point, I personally need an individivial / people who are willing to make a commitment to ensure that all need to work together in making sure our expenditure is on SCI result and any "associated" contacts (ie. sci-step, Miamai Project, etc) is a worthwhile endeaver.

dogger

08-06-2006, 05:50 PM

Hello all.

I am definitely sorry to all of those of you that were awaiting for a SERIOUS response to many much anticipated, much deservered and well-awaiting responses to the these much and as yet much to unanswered-questions which werew awaiting anticipated questions........................................

#1. Can't the Moderator mantain the current pulse of the members of ther CC community????? I know it's a difficicult job, so yes, I am offerring to step in assist as either a primary or a secondary alliaze.

At this point we all need to work together in making sure our expenditure is on SCI resul and

Laurie , was your question aimed at me ? If it was , sorry but I don't understand what you are asking .
Both myself and the clinical nurse running the trial I was in , are somewhat confused by Aventis'sinformation [or lack of it ] concerning the trial just finished and the liklihood of another trial .

I got definite improvement from HP184 and sincerely hope the trials continue . The clinical nurse got a 3 line preface from Aventis about the trial that basically said nothing when she received the dose rates of participants after the unblinding of the trial . Since then I have got unsubstantiated , third hand reports that there is some problem with the correlation and analysis of the results by Aventis . I have been trying to get further solid information but due to my location and other things like time constraints and lack of contacts I have not been able to find out anything concrete thus far . I'm a sheep and cattle grazier [ farmer ] living in outback Australia . My remoteness , telecommunications and lack of good understanding of how large international pharmaceutical companies operate is a bit of a roadblock .

The trial was run by Aventis's in India and being that I'm in Australia there is some problems with going through the tiers of Aventis's various international offices .

Laurie O'Connell

08-06-2006, 07:16 PM

With must due respect Dogger:

I'm really am trying to best respectfuly format my answer to you and the many of your followers. Please understand that I want to make a couple of sustaining results and recommendations:

#1. It is always helpful to have as many people on the inside of the pharmceutical companies as possible (yes it will payoff - and I make the commitment to be a contact of yours for live - if you so choose)
#2. You really need to maxmixe you contacts (with as many Pharmaceutical Companies as possibile so that each company wants to assist you more).

The whole idea behind this premise is that just like the Pharamceutical Companies never make guarantees about safety or efficacy with any of the product given to you or fellow patients, now you can re-event...now with all of the advantages being recently made in this field.

Just a short thought for now..............coninue to stay safe, love, at peace :)

dogger

08-06-2006, 08:04 PM

Thanks Laurie . I wasn't trying to scorn your efforts or reply in any way . I have used your information in the past while trying to sort this out . Unfortunately at this time I'm trying to have an input into a legislative debate going on in Australia about ESCR and therapeutic cloning which I consider more important due to it being an issue that is currently being decided . I have good contacts into the politics and science involved in ESCR etc [ I have received a call from a national current affairs show while doing this post ] , so I am concentrating on a field where I think I can have some impact .

I have been chasing this up when I have time . There is some really conflicting reports on the status of further HP184 trials . For example France will not allow another HP184 trial [ as reported on CC somewhere . It also seems that Aventis somehow seem to have screwed up their analysis and correlation of results . To be honest , I had some reservations of this trial from day one . Remylienation is important to MS recovery , yet there were [ to my knowledge ] no MS sufferers included in the trial . I also considered some things in the trial could have been done better . For instance I found the surveys we had to complete during the trial to be somewhat vague . They seemed to deal more with qualitive social issues than quantitive scientific gains .

I really want to see HP184 trials continue because I saw improvements . However I also have to try and make a living while pursuing these various issues . I own and run a 20,000 acre property singlehandedly as a C5/6 quad , so I my time to chase up SCI issues is somewhat limited .

Thanks again and I really do appreciate the information and insight that you give on pharmceutical companies due to your involvement with them . I am not brushing this under the carpet , I will try to get back onto it as soon as time allows . I continue to read your input with interest and will contact you if I have specific inquiries .