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patg
28th August 2011, 01:20 AM
Subject: Re: SM: Partcipants Needed for Normast Study



To all owners with definite diagnosis of SM (any breed confirmed by MRI) in their dogs – these can be dogs who have had the decompression surgery or not, but who are on some form of medicines for S

SM. We are looking for participants to take part in a study to compare the effects of Normast* with another drug (for instance gabapentin).If there is enough interest then Dr Nick Jeffery (ISU Vet School) could go on to the next stage of working out the details of how to make the study happen. This study would be done remotely. Dr Jeffery would coordinate it from a distance so one does not have to travel to Iowa (in the Midwest USA, for those who are overseas). ]Special tablets would be made up so that owners were not aware of what they were giving at each time, but each dog would get both treatments at some stage. The results could be collected by questionnaire
]In order to get the numbers for this study we are attempting to coordinate it from a distance. As part of his agreement to participate I have agreed to collect the emails to assess interest. I would just need the number of dogs you wish to enter into the study. I don’t want any details, whose breeding or any dog’s name. Once I have collected enough dogs for the numbers this would be turned over to Dr Jeffery. My only interest is getting this study underway. At this time this is being considered for the USA due to distances (have asked if Canada is included) if this changes will notify of that.
We have a real opportunity here for the sake of the dog(s with a Doctor willing to participate, please let’s get behind this.
At this time there is no funding this is being done “pro bonoOnce we have enough in way of the number needed of dogs whose owners are interested in participating, then Dr. Jeffery can set about working out the next stage as to how to make the study happen, but in order for him to setup the study we need to have interested participants.
Of course further details would be provided as this moves along, if we can get enough to participate to do the study.

Please feel free to pass this on to anyone and to cross post.

Thank you Jill Scandroli Catesby Cavaliers E-ml me privately at catesbycavs@bellsouth.net (catesbycavs@bellsouth.net[/SIZE][/FONT])
Normast has been used overseas in the Netherlands in a informal study for 70 Cavaliers to date, Normast has demonstrated some to complete relief of SM symptoms in less pain and return to more activity. This study is a attempt to undertake the 1st blind study to demonstrate this medicines effectiveness.

GraciesMom
28th August 2011, 02:05 PM
Have already signed up Gracie. Drives me nuts that gabapentin does not last overnight. Mornings are the worst because of it. Hope this one does the trick.

Kate H
28th August 2011, 02:51 PM
I'd happily sign up Oliver - if I happened to live in the US! Is Nick Jeffery the vet who used to be at Cambridge University Vet School and has done a lot of research into SM?

Kate, Oliver and Aled

PS Debra: I was interested that you wrote 'Drives me nuts that gabapentin does not last overnight.' As gabapentin is given at equal distances between doses, why do you find that it works differently overnight? Oliver has his 3 times a day, so 6am, 2pm and 10pm, and never has a problem overnight. The only time he occasionally needs an extra dose is late afternoon if he's had an active day. I suppose if he went on to four times a day I'd have to stay up until midnight!! Just being nosey!

Karlin
28th August 2011, 04:27 PM
Often when gabapentin doesn't work it is usually because the dose is too small. Or that the dog would do better on Lyrica. If it isn't lasting the night 1) the dose sounds too small, or 2) he dog needs extra painkillers (as is often the case) or 3) try Lyrica which generally gives a good result. :thmbsup:

I think this will be a very useful trial if it happens :) -- with some caveats however.

First off I would NOT -- absolutely no way -- recommend anyone doing it who has a dog that would be seriously uncomfortable if off gabapentin.

Also be aware that this is a very expensive treatment -- at least as much, or up to twice as much, as Lyrica (pregabalin) on the 'recommended' dosage (what they estimate would be for very small cavaliers, like 12-15 lbs. For a more typical size, the dog would need a higher dose, up to twice as much). I'd have to see a heck of a wonder drug to choose to use this over what already works and costs far less -- eg gabapentin. I also am made a bit uneasy that the guy/MD behind the company goes around pain discussion boards promoting these quite costly pills.

Also it is a bit fuzzy of the company to say Normast demonstrated 'some to complete' resolution of 'symptoms' (some which are a bit strange and won't really fit what many of us recognise as symptoms. It was only a two month trial and some of the 'complete' things were pretty minor and some areas seem pretty subjective (I've never linked 'closed eyes' to headaches and evaluating canine signs of a headache has been extremely difficult to do objectively by neurologists). I'd also like to see something last 6 months to a year.

And it was not 70 CKCS (not sure where that number came from?) -- it was 12 according to the company's own literature-- a small sample, and only based on owner responses, not a pre and post clinical exam by a neurologist. Given that owner interpretation is well known to be very subjective on pet trials, the results really need to be taken with caution. Hence a rigorous larger trial run by a third party rather than the people in the company that sells the treatment would be very useful! So I hope this happens.

http://www.neuropathie.nu/research-development/syringomyelia-in-cavalier-spaniels-treated-succesfully-with-no.html

My own feeling is that it may be a useful addition to gabapentin rather than a replacement.

anniemac
29th August 2011, 01:48 PM
[removed by admin. If people are interested, Anne, please just send them this long crosspost privately. Most of this info is all contained on the Normast website and I do not want to advertise their product or its claims here -- people can read for themselves the company info, and get Jill's further info directly from you if they wish or email her directly as per the original post.]

anniemac
29th August 2011, 01:50 PM
I'd happily sign up Oliver - if I happened to live in the US! Is Nick Jeffery the vet who used to be at Cambridge University Vet School and has done a lot of research into SM?

Kate, Oliver and Aled

PS Debra: I was interested that you wrote 'Drives me nuts that gabapentin does not last overnight.' As gabapentin is given at equal distances between doses, why do you find that it works differently overnight? Oliver has his 3 times a day, so 6am, 2pm and 10pm, and never has a problem overnight. The only time he occasionally needs an extra dose is late afternoon if he's had an active day. I suppose if he went on to four times a day I'd have to stay up until midnight!! Just being nosey!

Kate,

It is the same Dr. Jeffrey that came from the UK. I just posted some more information.

anniemac
29th August 2011, 01:59 PM
I think the 70 Cavaliers vs. 12 is the amount that are now being treated since the study of 12? It says from the emails Jill has since trying to gain information.

In my opinion whether this proves to help in addition to gabapentin or as a replacement, it still seems something that might be helpful. If Ella was still around, I would participate. Let's hope that enough volunteer so that we can find out if this is something that will benefit many with pain in the future.

GraciesMom
29th August 2011, 07:42 PM
PS Debra: I was interested that you wrote 'Drives me nuts that gabapentin does not last overnight.' As gabapentin is given at equal distances between doses, why do you find that it works differently overnight? Oliver has his 3 times a day, so 6am, 2pm and 10pm, and never has a problem overnight. The only time he occasionally needs an extra dose is late afternoon if he's had an active day. I suppose if he went on to four times a day I'd have to stay up until midnight!! Just being nosey!

From what I understand, each dog is different in terms of how long it lasts. For Gracie, the effect starts wearing off after 7 hours, so if I give her to her at 10 pm, but 6 am is worn off. She does not get up and walk until around 7 am and the new dose has not kicked in. Upping the dose only seemed to make it stronger but still wore off in 7 hours. So maybe we do need to look at another medication like Lyrica. I will check into that Karlin. She does do better if we have also given her a dose of Tramadol just before bed.

Gracie, fortunately, does not get bad symptoms, so it means a bit more scratching in the morning until the morning dose takes effect. If we skip a dose, the same thing. I think we could do the trial without a problem. I did ask our neurologist about it first, which I would recommend to anyone interested in the trial.

Karlin
29th August 2011, 11:48 PM
I am all for a double blind trial (though it cannot really be double blind if based only on owner responses but at least would be a third party trial, a positive) but I cannot imagine a lot of people given the option would go for Normast, at current cost, if it was shown to be a possible replacement for gabapentin etc -- many people already feel Lyrica isn't an option due to cost. As it isn't a prescription medication I wonder if it would be covered by anyone's insurance either.

Interesting the company are now saying the dogs would need to be on 600mg daily of Normast, which costs 26 euro for only 20 600mg pills plus shipping :yikes. That would make it more expensive than Lyrica, which is costed based on millions of dollars of clinical trials-- how can they justify more than a euro a pill? That is also about double the dose they originally said was beneficial in the link I put in above, where they say they saw all these benefits at only 150mg 2x. I wonder what changed?

As I said personally I would not put a dog with any more than mild to very moderate symptoms into a pain trial where it might have to endure two months of inadequate pain medication. Ethically I do not think it right to have someone's dog suffer for a trial. Others may be willing to risk that but I would not ever consider putting Leo into a trial that could leave him with inadequate pain cover for two months of a blind trial.

Kate H
30th August 2011, 11:58 AM
What happened to the trial that the Royal Veterinary College did several years ago to find a more effective pain control for SM? It seemed to just fizzle out and never got reported. Or did I miss it?

Kate, Oliver and Aled

Karlin
30th August 2011, 01:21 PM
As far as I know, the trial happened. But it can take a very long time for results to be published, and in the meantime, they generally are not formally reported. Reporting results in advance of peer-reviewed publication/the formal wrapup and write up of a clinical trial would be very unprofessional for a large drug company and could also open them up to regulatory violations and lawsuits. I will see if I can find out what the current situation is with that RVC trial.

GraciesMom
30th August 2011, 02:43 PM
The early results seemed very positive. Gracie is fortunate that she does have mild symptoms and our neuro thinks the early indications on this are positive. Maybe it is expensive drug at this time, but we have to start somewhere to test the options and some of us are in the position to do so. If your dog is very uncomfortable not being on any meds, then definitely do not do it. It is not likely to be available for dogs for a while but would like to be part of research if we can.

Karlin
30th August 2011, 03:59 PM
Debra -- Anyone can buy this stuff right now and it isn't a drug per se. The study is not a clinical trial of an experimental drug either–it is an over-the-counter (but very expensive) product anyone can buy. All you have to do is use the website in the Netherlands and they will ship to you. The only reason a separate trial is being suggested, is to get some independent results as the company are making claims based on their own trial but there's no independent verification. If anyone feels their own results are compelling, people can use a credit card and buy from them right now.

Trying to get clarification about a product or pointing out that it is more expensive than the most expensive currently available prescription medication does not mean people do not support a trial. :sl*p: I have already clearly stated that I do support a trial for a whole range of reasons, and I would like to see more research on products and potential medications that fall into the same general area - cannabinoids. Some of us have been trying to see if a trial could be done on some of the cannabis derived products that are beginning to emerge as well. Initially, I had thought that this product was one of those, but only on clarification did I realize that it was the product associated with the study done last year that I read about at the time. I had thought that original in-house study had already been posted up here on the board ages ago as it was circulated around some of the discussion lists back then, but apparently not as I cannot find it in the archives.

anniemac
30th August 2011, 04:20 PM
Karlin is correct about being able to get it now. I found a link to it online some time ago about the dogs in the Netherlands. I think there are several articles and some humans are using it. I sent the information to someone that I thought it would benefit previously. I think the breeder would have shipped some if needed (Ella was already deceased). At the time it was something like 12 Cavaliers but it looked promising. I don't know what goes into the study but I think that is why they want to see if there are enough participants before putting much effort into it.

As posted, you can get more information by email provided.

GraciesMom
30th August 2011, 04:25 PM
I am not an expert., as you can tell. I would still like to know if something that might be available to us down the road may or may not work better than gabapentin. They may learn something from this study that could be used to configure a different medication down the road, even if not in Gracie's lifetime. I do not plan to order it from the Netherlands, but maybe some participants like it so much and have the money that they would. Because it it pricey now does not mean it always will be. Just my own personal choice to participate since Gracie has mild symptoms. If another drug with good results was being studied and we were eligible, I might consider that too. They have not released the specifics on the study yet and I may bow out when I get that information.

Kate H
30th August 2011, 06:02 PM
I asked about the RVC trial, Karlin, because I can remember going to a health meeting, I think spring 2 years ago, and the RVC people said that they would have news for us in the autumn, so as nothing seems to have been said 18 months later, I wondered if there was a glitch. If anything has been made public, I think it would have been reported on the Cavalier Club website, because they were encouraging people to take part in the trial. I suspect the RVC were negotiating with a pharmeceutical company or something to develop the drug or do more trials, and perhaps that fell through. If there is anything new in the pipeline, I hope it won't take the 17 years to produce that is apparently the everage for new human drugs!

Kate, Oliver and Aled

mommytoClaire
30th August 2011, 11:08 PM
Debra, I think it's noble that you'd like to participate even if all it's to do is help future pet owners with pain resulting from SM/CM. Of course, the specifics may change your mind.

It does seem that most products when first introduced are higher In price but as demand increases, the price goes down.

Here is a question for those more in the know......is this product sold more as a 'herbal' type med (meaning, you are able to order it on your own directly) because it's manufactured in the Netherlands? And I am assuming it wouldn't be covered under insurance because it's not a 'prescribed' drug by the Veternarian community?

Just learning as I go along.

patg
31st August 2011, 05:26 PM
Just to calrify the number of dogs involved it was 12 dogs to begin with but after 2 months of good results with those 12 additional dogs were added to where the total dogs was 70 after 6 months. That is where those numbers came from.