on 50 children for ivig study?

[Priscilla]

PANDAS network reports a tentative 50 children for the ivig study, wasn't Swedo's study on about 30? Haven't we heard this was too small a study to be significant? Won't limiting it to 50 children give the naysaysers the same argument? Seems as though you wouldn't have to look to hard to find more than 50. uggh I guess its a start

[kimballot]

The study with 30 kids had 3 different groups (IVIG, PEX, placebo), with about 10 per group. This one only has two groups (IVIG, placebo) with presumable 25 per group, so there will be more than twice as many kids per group. Also, I would assume that the folks developing the protocol used statistical analyses from the last study to determine how many kids are needed in the study. if you are doing an experimental study, Human Subjects review boards don't usually let you do many more than absolutely necessary because they don't want to increase the number of kids being placed at risk (risk of treatment ANd risk of not receiving treatment quickly if you are in the placebo group).

 

Personally, I would love to see 100 or 200 kids in the study.. but I don't think we'd see results for many years. I a just keeping my fingers crossed that we get the results we are all anticipating!

[Iowadawn]

Another neat "feature" (that bolsters the study) is that the placebo kids will be offered the IVIG at the 6 wk or 3 month mark(I don't have the study handy). I am hoping the data will be sooooo abundantly clear that some the results will be known well ahead of the 3 year mark and IVIG will be treatment option, period.

[thereishope]

Well, in the current study they are enrolling 50 kids but it also says this

Study Population: Thirty-two male and female children with severe obsessive-compulsive symptoms related to a new onset or first recurrence of symptoms consistent with the PANDAS subtype of OCD.

 

So, does that mean the study consists of only 32 kids, but enrolling 50 in the event someone has to pull out?

[wornoutmom]

While I am very thrilled this study is happening, my heart sunk when I read it will be 3 YEARS!! Wow - my son will be 18 (and diagnosed for 12 years) before these results are published. Makes me feel so much empathy for all those parents of kids who were disabled (or died) of polio before they came up with the vaccine.... I am very glad that a few will be able to turn to the study though and receive IVIG without cost. I do wonder about the placebo group though. Won't it become obvious to the kids/parents which group they are in when the side effects (fever, migraine, vomiting) of infusion kick in? And how will that knowledge effect reporting of symptoms? And if these kids have strep infection, are they going to be allowed antibiotics? and if so will that effect the results? and after 3 months wait for the placebo group isn't it possible that the symptoms might naturally wane as the infection that brought them there in the first place subsides? and of course, like any study, my heart breaks for these kids and families in the placebo group who's symptoms don't wane, and they wait through all this ###### for 3 more months for IVIG. 3 months is a really long time when you're in exacerbation....

[Worried_Dad]

While I am very thrilled this study is happening, my heart sunk when I read it will be 3 YEARS!!

 

Amen, sister. The sad truth is that most of our kids are the guinea pigs and the pioneers on the PANDAS/PITAND frontier. I'm praying that our children's experiences will smooth the path for future kids... but I've resigned myself to the harsh reality that we're kind of on our own for now.

 

This is definitely progress, and I'm excited to see it happening. But - as Buster posted recently - if we're lucky, then maybe 5+ years from now, mainstream medicine will finally have a clue about how to approach this illness.

[VickyLH]

Well, I just got off the phone with a social worker from NIMH who did an eligibility phone interview regarding my ds11. Unfortunately she said she didn't think he was a candidate because his symptoms had been going on for too long. I really don't understand this, because although we now believe he exhibited PANDAS symptoms on and off when he was ages 5-8, he was never diagnosed or treated for it. His most recent exacerbation has been going on since later November/December. He also was well for a solid 2 years before Strep crept back into our lives and turned it upside down this time. He has never been treated for PANDAS symptoms, other than the 30 day abx he is currently on - no IVIG, no steroids, nothing! I don't get it. She said she will discuss it with the core investigators and if they decide he is eligible she'll contact me in 1-2 weeks, otherwise I won't be hearing back from her. I'm praying that he is eligible because my husband's company is in the midst of bankruptcy and he won't be employed much longer. I work part-time and will eventually switch the family to my insurance (United), but I'm worried that insurance won't cover IVIG and we won't be able to afford it for a while. Please say a prayer for my son so he can get the help he needs.

 

Thanks,

Vicky in NC

Edited January 26, 2011 by VickyLH

[thereishope]

I'm sorry! However, from what I gather, UHC is one insurance that usually covers IVIG.

 

 

Well, I just got off the phone with a social worker from NIMH who did an eligibility phone interview regarding my ds11. Unfortunately she said she didn't think he was a candidate because his symptoms had been going on for too long. I really don't understand this, because although we now believe he exhibited PANDAS symptoms on and off when he was ages 5-8, he was never diagnosed or treated for it. His most recent exacerbation has been going on since later November/December. He also was well for a solid 2 years before Strep crept back into our lives and turned it upside down this time. He has never been treated for PANDAS symptoms, other than the 30 day abx he is currently on - no IVIG, no steroids, nothing! I don't get it. She said she will discuss it with the core investigators and if they decide he is eligible she'll contact me in 1-2 weeks, otherwise I won't be hearing back from her. I'm praying that he is eligible because my husband's company is in the midst of bankruptcy and he won't be employed much longer. I work part-time and will eventually switch the family to my insurance (United), but I'm worried that insurance won't cover IVIG and we won't be able to afford it for a while. Please say a prayer for my son so he can get the help he needs.

 

Thanks,

Vicky in NC

[VickyLH]

I'm sorry! However, from what I gather, UHC is one insurance that usually covers IVIG.

 

 

Well, I just got off the phone with a social worker from NIMH who did an eligibility phone interview regarding my ds11. Unfortunately she said she didn't think he was a candidate because his symptoms had been going on for too long. I really don't understand this, because although we now believe he exhibited PANDAS symptoms on and off when he was ages 5-8, he was never diagnosed or treated for it. His most recent exacerbation has been going on since later November/December. He also was well for a solid 2 years before Strep crept back into our lives and turned it upside down this time. He has never been treated for PANDAS symptoms, other than the 30 day abx he is currently on - no IVIG, no steroids, nothing! I don't get it. She said she will discuss it with the core investigators and if they decide he is eligible she'll contact me in 1-2 weeks, otherwise I won't be hearing back from her. I'm praying that he is eligible because my husband's company is in the midst of bankruptcy and he won't be employed much longer. I work part-time and will eventually switch the family to my insurance (United), but I'm worried that insurance won't cover IVIG and we won't be able to afford it for a while. Please say a prayer for my son so he can get the help he needs.

 

Thanks,

Vicky in NC

Thanks, that's good to know! I need to look into it more, but with the new Health Care reform, are pre-existing conditions a non-issue now?

[thereishope]

I believe they are a non-issue, especially when it comes to children.

 

 

Thanks, that's good to know! I need to look into it more, but with the new Health Care reform, are pre-existing conditions a non-issue now?

[tpotter]

Also, if you're not accepted for the study, I think you should see a good immunologist, like Dr. B., who knows what he's looking for. If he finds an immunological deficiency, you may have a much easier time getting insurance to pay.

 

I will keep you in my prayers.