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Xyrem trial in Belgium!?!

Discussion in 'Active Clinical Studies' started by Snow Leopard, May 21, 2012.

  1. Snow Leopard

    Snow Leopard Senior Member

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    So Belgian investigators are doing a double-blind/crossover trial of Xyrem, AKA Sodium Oxybate, AKA Gamma-Hydroxybutyric acid (GHB).

    http://clinicaltrials.gov/ct2/show/NCT01584934

    Now I'm all for experimental trials to investigate repurposing of drugs for other conditions, but GHB?

    While poor sleep can increase the severity of symptoms, drowsiness due to lack of sleep is fundamentally distinct from the fatigue experienced in patients, see studies such as: http://www.ncbi.nlm.nih.gov/pubmed/19021860
  2. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    i would jump at a trial like that, supposedly its a med that increases stage 4 restorative sleep, im sure it would go along way to improving the immune system. Stage 4 sleep also improves growth hormone secretion which can greatly improve pain as well as general recovery from activity, potentially reduce PEM. I think if someone with cfs didnt have sleep problems but was the type who maybe slept all the time, then u would have to think twice if it would really help but if your the wired but tired cfs person then potentially it could really help. Now after saying all this i have heard from some people who said they didnt get that great of a response from it and preferred normal sleep meds, but u dont know unless u have a go i suppose.

    cheers!!!
  3. August59

    August59 Daughters High School Graduation

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    This could have something to do with Jazz Pharmaceuticals (makers of Xyrem) have been bought be a Belgian or Ireland company.

    SDS Pharmacy will confirm this as they have had plenty of calls about Xyrem about this particular condition or situation. I have taken Xyrem on 3 different occasions. The first 2 times went real well and reason for starting and stopping was changing of insurance and amount of co-pays. The 3rd time I took it was approximately 6 months ago and after about 3 weeks I developed anxiety and panic so severe that I did not think I was going to make it. After about 3 days I had to take .5mg of Xanax and within 30 minutes I felt as if I had never took it to start with, but of course that did not last long. I called SDS Pharmacy and they have several accounts of people that are going through a period if severe anxiety (which I was this time and was not the first two times I took it). SDS on the other hand did not have any answer and could not get one out of Jazz Pharmaceuticals. Their answer was to stop taking the med, which I did and in about 6 -7 days the anxiety subsided and I waited about a week and started up slow again. After 3-4 days the anxiety was back and just as bad.

    What I can't figure out is something that has a half life of about 3 hours can cause severe panic and anxiety for 6-7 days. I know a lady that takes it for 3 days on and 3 days off, while taking Ambien on the days off and she does fine, but she cannot take Xyrem any longer than than that without severe anxiety and panic and occasional emergency room.

    Xyrem effects something that severe stress effects as well and last longer than 30 times it's half life. The only thing that I noticed different is that in the mornings when I woke up, I actually jumped straight up in bed before I could even open my eyes good. I'm would think it has an effect on more than just GABA. Some people feel like it cause a dopmine surge, but I have not found any scientific study to confirm this and SDS Pharmacy and Jazz Pharmaceuticals does not seem to want to give an answer if they have one.

    Just a word of caution!
  4. FancyMyBlood

    FancyMyBlood Senior Member

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    I don't know if they've been bought out, but I do know that a Belgian company (UCB) has the rights to distribute Xyrem in Europe. They're a sponsor of this trial btw.
  5. Desdinova

    Desdinova Senior Member

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  6. LaurelW

    LaurelW Senior Member

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    I took Xyrem for a period of six months when nothing else would work for me. It helped a lot. My insurance paid all but $50 of the cost. I tried to take it again about a year ago, had to appeal to my current insurance, which I won, but then discovered that the current cost would put me in the Medicare donut hole in about 2 months. So I've had to take a combination of other drugs instead.

    I understand about being wacko if you take it and don't fall asleep, though. It's a pretty wild ride.
  7. perchance dreamer

    perchance dreamer Senior Member

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    Xyrem helped give me my life back. My insurance covers it so that my copay is $35 a month.

    That said, I did have trouble with Xyrem until I got on methyl donors. Although I had addressed neurotransmitter and hormone imbalances, I think my methylation problem was so severe that it had to be addressed before I could start sleeping better. Some people might have other medical conditions that cause Xyrem not to work as well as it should.

    I also think it's important to titrate VERY slowly on this powerful drug. I started at 5 ML twice nightly and stayed on that dose 2 weeks. Then I went up 1/2 ML at a timefor 2 weeks until I got to the dose best for me, 6 ML twice nightly.

    I just wanted to add the perspective to this thread that Xyrem does help lots of people. The Narcolepsy board on the Talk About Sleep web site is excellent for reading about people's experiences with Xyrem.
    ggingues likes this.
  8. redo

    redo Senior Member

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    The reason it has such a bad reputation is that when it's abused it's often mixed with a lot of alcohol - which in turn makes people really prone to overdosing into a comatose state. Taken medicinally it's really not that dangerous, and if taken only at certain times of the day at certain doses, the addiction potential is much lower than for benzodiazepines. The addiction potential was among others described by prof. David Nutt, 2010, Lancet. The substance even occurs naturally in the body - it's among other things found in very low amounts in beef. I haven't tried it before, but if my doctor would offer it, I would try to replace my 5 mg ambien with a low dose Xyrem. The ambien doesn't really work that much taken long term anyhow, so it's doesn't have to wipe out the insomnia to be a better alternative.

    I agree it can't be a cure, it doesn't address the core cause, and CFS and fatigue from insomnia are totally different, but if better sleep gives the patients somewhat of a general symptom relief, than that's a good thing by it's own.
    helios and ggingues like this.
  9. August59

    August59 Daughters High School Graduation

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    This is GHB, but the addition of the high sodium content was the only way the FDA would allow it. You will not slip this stuff into anyone's drink without them noticing it. Another thing to keep in mind is the maxium dosage used is equal to about 1/10th of what street users are using plus Xyrem is a clean medicine. GHB on the street is made with paint thinner and some form of potassium or possibly calcium. You can by the kits on the internet.

    The real kicker is up until somewhere around the mid 90's a stronger version of GHB could be bought in just about all health food stores due to bodybuilders and powerlifters used it for growth hormone release. Very, very few of these guys ever got addicted to it because they took it just as directed and didn't know any better.

    Correction: Jazz Pharmaceuticals bought EUSA Pharma Inc which has headquarters in the US, UK, Portugal, France, Canada and Germany
  10. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    august, do u think it was a rapid withdrawal effect that gave u the anxiety. Sleep meds with short half lives have been known to cause similar things but not as strong as u mentioned though.

    I remember reading a few bodybuilding mags in the early 1990s where they sold ghb as a supplement to increase growth hormone etc many said it did help them lose weight and sleep very well. Im sure the price was like $20 a bottle and it came in tablets too. I dont understand how they can get away with selling xyrem for such big prices. If one was game, there are even formulas on how to make your own ghb from cheap house hold products??? Anything reguarded as medical they jack the prices way up.
  11. CFS-FIBRO-LYME

    CFS-FIBRO-LYME

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    I'd stay away from Xyrem. I tried it for sleep years ago and all I got for it was really high blood pressure and quit it after a few days.
  12. ggingues

    ggingues $10 gift code at iHerb GAS343 of $40

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    I think people should not nix this right off. I had a major flare up over 2 years ago and found a good med for sleep, not xyrem, an anti-depressant, and I have been feeling and doing better, year after year!

    GG
  13. helios

    helios

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    Just saw this thread about xyrem trial. I think its great that it is being investigated for CFS and would have loved to have taken part in the trail, though like Desdinova, I'm a little sceptical given it got knocked back for FM. Maybe they figure CFS will get more support or maybe it could be approved in europe. Having low GH/IGF + unrefreshing sleep it is something I would love to try. I agree with HR that its sold at ripoff prices. I dont know how the hell Jazz got given exclusive rights (I believe also a patent) to this drug, which as someone else pointed out occurs naturally.

    For anyone here that has taken part in drug trials, do you have to live in the same city where the trial is, or can you take part living say in another country, using the support of your doctor?
  14. Snow Leopard

    Snow Leopard Senior Member

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    As a general rule, you have to be able to regularly attend the clinic/hospital(s) where the trial is being conducted.
  15. Otis

    Otis SeƱor Mumbler

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    I was able to get an off-label trial of this because I haven't had any slow wave sleep for at least a decade. Unfortunately it didn't work for me because it completely zapped my REM and didn't really give me and Slow Wave Sleep - so it let me worse off - which I didn't know was possible. From my research and online patient conversations Xyrem is either a miracle drug or a complete bust. But it helps enought people that it should be available.

    I completely agree, at least in the US, that it will never be approved. There is literal fear of this compound despite the fact that it is so freaking salty that it can't really be a date-rape drug and if the control of the med stayed the same it would be hard for much abuse to occur. People who need this med aren't likely to sell it for any price. My Rheumatologist (who supported approval) was in the loop on the process and confirmed that the fear making the med more widely available won the day over helping patients. Do no harm my a$$.
  16. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    So Otis, normally do u only get REM sleep with no deep sleep?

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