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Thread: CM/SM clinical trial

  1. #1
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    Default CM/SM clinical trial

    The following is on the Cavalier Club website: (from Kate, Oliver and Aled - can't get my signature in after the notice!)

    Clinical Trial
    Comparison of two different treatment options for the management of neuropathic pain in Cavalier King Charles Spaniel dogs with Chiari-like Malformation/Syringomyelia.
    Background Information

    Syringomyelia is common neurological condition of Cavalier King Charles Spaniels (CKCS) that is characterised by the development of fluid filled pockets (syringes) within the spinal cord caused by changes in the flow of the fluid in the brain and the spinal cord due to Chiari-like malformation. Syringomyelia is often presented with episodes of facial rubbing, pain, scratching and / or lameness.

    Currently, many different drugs have been proposed for Chiari-like malformation and syringomyelia but there is no evidence that any of these drugs is actually helping to improve the symptoms.

    Purpose of this Research Trial

    The aim of this multicentre study is to determine the best available medical treatment for dogs affected by Chiari-like malformation/Syringomyelia.

    Which dogs can be enrolled in the trial?

    Only CKCS dogs with MRI confirmed Chiari-like malformation and/ or syringomyelia can be included in the trial. These dogs must show clinical signs of neck/ back pain, air scratching, facial rubbing, screaming/ yelping episodes or wobbliness. Dogs with kidney or gastro-intestinal disease cannot be included.

    Are there any side effects associated with these drugs?

    No serious side effects have been reported with the use of these drugs which have been used in dogs before and no placebo treatment will be used. Some dogs may experience vomiting, diarrhoea, drowsiness or wobbliness. However, your dog should not participate in the trial if it has history of kidney disease or gastrointestinal disease.

    Do I need to pay for anything?

    The cost of the treatment can currently be offered free for CKCS participating at the RVC site and the owner of the dog will not pay for any consultations or re-examinations associated with this trial.

    Right of refusal to participate and withdrawal

    You are free to choose to participate in the study. You may refuse to participate without any loss of benefit. Your dog will receive the same standard care and treatment which is considered best irrespectively of your decision to participate in the study. You may also withdraw at any time from the study.

    Confidentiality

    The information provided by you will remain confidential. Nobody except the veterinarians involved in the care of your dog will have access to it. Your name and identity will also not be disclosed at any time. However the data may be seen by an Ethical Review Committee and may be published in journal and elsewhere without giving your name or disclosing your identity.

    If you want to participate in this trial and hopefully make a difference to dogs suffering from Syringomyelia / Chiari-like malformation, please write an email to ckcstrial@gmail.com or contact one of the centres directly and ask for the person involved in the study.

    Collaborators:
    • Royal Veterinary College, University of London
      www.rvc.ac.uk/QMH/Contact.cfm
      – Ioannis (Johnny) Plessas DVM MRCVS
      Senior Clinical Training Scholar
    • Queen Mother Hospital Royal Veterinary College, University of London
      – Holger Volk DVM PhD DipECVN FHEA MRCVS
      Senior Lecturer in Veterinary Neurology and Neurosurgery
    • Queens Veterinary School Hospital, University of Cambridge
      www.vet.cam.ac.uk/contact/
      – An Vahaesebrouck DVM MRCVS Clinical Neurologist
    • Stone Lion Veterinary Group, London
      www.veterinary-neurologist.co.uk/
      – Clare Rusbridge BVMS PhD DECVN MRCVS
    • College of Veterinary Medicine, Iowa State University
      vetmed.iastate.edu/front-page/contact-us
      – Nick Jeffery BVSc PhD CertSAO DSAS DECVN DECVS FRCVS
      Professor of Veterinary Clinical Studies.

  2. #2
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    If one of the drugs are Zitac and my dogs see Clare then I would be more then happy to take part as two of my dogs are allready on it. I will email Clare.
    Sabby
    Rosie-06/06 - Ebony-01/07 Harley-08/08
    " My sunshine doesn't come from the skies, it comes from the love in my dogs eyes "

  3. #3
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    Hi Sabby:

    You won't be able to know either what the drugs are, I think -- it will likely be a blind test.

    Just saw there will be no placebo so presumably they give the dog one or the other medication -- though maybe they will swap them partway through?
    Karlin
    Cavaliers: Jaspar Leo Lily Tansy Libby (foster) Mindy (foster)
    In memory: Lucy
    Cavalier SM Infosite:www.smcavaliers.com

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    Now there is a dilemma. I really believe in supporting these studies and Tommy does seem to fit with the criteria.

    I'm just so worried that taking him off the Lyrica will mean he will be in considerable discomfort again.

    I will need to get in touch with Clare & check out. I suppose I can always abandon the trial if he gets worse.
    Margaret C

    Cavaliers......Faith, The Ginger Tank and Woody.
    Japanese Chins.... Dandy, Benny, Bridgette and Hana.
    Remembered with love......... Tommy Tuppence and Fonzi

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    I wonder if Charlie would be a good candidate??

    He has CM only and takes only Zitac and Metacam- I certainly dont think Id put Ruby on it as Id never take her off of Lyrica but with Charlie we are still in trial and error stages??

    Only problem is that Id worry if any of the medication would affect his heart?

    Karen

    Ruby - my stunning soul mate who defies the odds every day
    Charlie- my angel at heart and devil at play


  6. #6
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    If Zitac would be one of the drugs they are using why can't the dogs allready taken the drug stay on the same drug and join the study. Just find other dogs to take the other drug. I woudn't even mind if I keep paying for the Zitac. It's just helping research.

    Margaret - I am sure it doesn't mean they can't take any pain relief like Lyrica or Gabapentin, lets face it they would have to find asymtomatic dogs only for the trial. Clare was telling me that even with symtomatic dogs on Zitac if you rescan every year you will see if the Zitac is helping. That's the way I understood it anyway.
    Sabby
    Rosie-06/06 - Ebony-01/07 Harley-08/08
    " My sunshine doesn't come from the skies, it comes from the love in my dogs eyes "

  7. #7
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    Quote Originally Posted by Karen and Ruby View Post
    I wonder if Charlie would be a good candidate??

    He has CM only and takes only Zitac and Metacam- I certainly dont think Id put Ruby on it as Id never take her off of Lyrica but with Charlie we are still in trial and error stages??

    Only problem is that Id worry if any of the medication would affect his heart?

    Just read it again and it says the dogs taking part have to show signs of pain so they would be on pain relief like Lyrica or Gabapentin. So all they would add is one of the two drugs. My Ebony has got a heart murmer and she is on Zitac.
    Sabby
    Rosie-06/06 - Ebony-01/07 Harley-08/08
    " My sunshine doesn't come from the skies, it comes from the love in my dogs eyes "

  8. #8
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    The reason dogs taking a drug cannot just join the trial and stay on the drug is: 1) because you won't know what the drugs are or trials become too prone to subjective perceptions and 2) the point is a comparison of drugs and dogs need to go off what they are on to some degree.

    Clare Rusbridge has kindly clarified:

    Dogs have to be off all medication for 48 hours before start so the ideal candidates are dogs that are not on any medications yet especially as there is a period where just on Rimadyl. Dogs that are on any drugs which are not part of the trial will have to discontinue them e.g. cimetidine.

    They start on the Rimdayl for a week then the first drug for 2 weeks then just rimadyl for a week then swap to the second drug for 2 weeks (recording the clinical signs before and after each stage). The drugs are blinded as much as possible. At the end of the trial there is an option to choose which drug was the most effective and the dog can continue on that.

    No dogs with gastrointestinal or renal disease, heart disease but not heart failure is OK
    Karlin
    Cavaliers: Jaspar Leo Lily Tansy Libby (foster) Mindy (foster)
    In memory: Lucy
    Cavalier SM Infosite:www.smcavaliers.com

  9. #9
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    All you can do (which I have done) is email one of the contact addresses giving details of your dog's present state and medication and ask if he/she would be a suitable candidate for the trial. If he/she isn't right for it, they will say no; if they say yes, that means they feel the dog can take part without compromising its wellbeing. And if you take part and are not happy with the way things are going, you can withdraw your dog.

    Kate, Oliver and Aled

  10. #10
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    SORRY I got it all wrong.

    I thought they are looking to see if Zitac helps in the progression of SM.

    I wouldn’t put any of mine forward as I just about got their medication right.
    Sabby
    Rosie-06/06 - Ebony-01/07 Harley-08/08
    " My sunshine doesn't come from the skies, it comes from the love in my dogs eyes "

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