Should daughter participate in clinical trials for absence medications?

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DadDavid - 26 Oct 2005 02:31 GMT

My 9 year old daughter has just been diagnosed with absence seizures
after an EEG. The local children's hospital has offered to include her
in a NIH clinical trial of the three main drugs for absence seizures.
It's a random, double blind study so we would not know what medication
she is on. I know little about treatment options, though none of the
three seem to be the preferred drug of choice. I'm most concerned
about side effects as (1) we will have to watch for three separate sets
of side effects and (2) depakote's tendency to cause weight gain. The
first neurolgist we saw said she would not recommend depakote due to
its side effects.(My daughter is around 90% on weight charts and 50% on
height.)

I'd appreciate hearing other parents experience about medications,
especially depakote, and if others are participating in this or similar
clinical trials. Although there would be more follow up in the study
and the doctor is well-regarded, I'm not sure the trade-offs are
necessarily worth it. (The treatment alternative is another neurologist
on the hosptial staff, whom we would see less often.)

Finally, because her episodes, though several per day, are minor (i.e.,
fluttering of eyelids for 2 seconds and then return to consciousness),
I've wondered if not giving any meds is a viable choice. Since her
grades are excellent, there does not appear to be any major problem now
and most children in this situation will outgrow the seizures during
teenage years.

Thank you in advance for your help.

David

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G.Ross - 26 Oct 2005 04:54 GMT

> My 9 year old daughter has just been diagnosed with absence seizures
> after an EEG. The local children's hospital has offered to include her
> in a NIH clinical trial of the three main drugs for absence seizures.

** Did they say they were going to try 3 new drugs simultaneously? Normally
when a new drug is ready for human testing it has gone through 2-3? years of
animal and other tests, and *1 Med. is given to half a sample of the test
people, and a 'sugar pill' to the other half.
A 'double blind', means that *half of a group of patients are labelled
e.g. A, and the other half B, then the Real Drug is labelled one of C *or
D, and the Sugar pills the *other of C or D. The people who divided the
group of patients into A and B, don't know which of C or D tablets is the
**Real medications and which is the sugar pill (that makes it double-blind
so they can't give a pill on purpose to a particular set of patients based
on any personal biases). Those overseeing the test can then match the
reactions of how A/D responded to the *Real Drug, versus the other half (for
example) who were in Patient group B/ using a Sugar Pill (C) . /

> It's a random, double blind study so we would not know what medication
> she is on. I know little about treatment options, though none of the
> three seem to be the preferred drug of choice.

*** I don't understand how you'd know that. Since the New med. is one they
have done preliminary tests for the type of szrs. she now has, *or she will
get the 'sugar pill' (above) and have no effect or improvement
(presumably), but not be any worse?
Unless someone else here has experience with how Double Blind tests are
done, if they differed from what I described above, they only test *1 pill
versus a 'placebo' (sugar pill), on a particular test. They don't mix *3
pills among a larger group of patients-- sorting *that out or results vs.
expected symptoms and real pills would be a Major headache to do, I'd
expect.. /

I'm most concerned

> about side effects as (1) we will have to watch for three separate sets
> of side effects and (2) depakote's tendency to cause weight gain. The
> first neurolgist we saw said she would not recommend depakote due to
> its side effects.(My daughter is around 90% on weight charts and 50% on
> height.)

*** Where did the Depakote come from? If they're giving her 'new
wonderdrug' or 'sugar pill', she wouldn't be given depakote unless the Dr.
or ?? prescribed that directly to her. *During the test of the 'new pill',
I'd assume she wouldn't be prescribe *anything else, or how would they know
how the New Wonderdrug worked, and were her symptoms from Depakote or
Lamictal or what?
Unless Dr. Bob is around or Howdy Dave (our statistician), I don't *think
she'd get any other pills during the dbl blind tests you described. She'd
either be taking a 'non-pill (sugar pill)' or the 'new improved test pill'
they're studying, and based on other tests they've done, are at point where
they *think this is a new pill that would work for Young People who have
Absence seizures.
I think normally this type of double blind test might run for 3-6 weeks
maximum. They want it long enough for any negative side effects (rashes,
upset stomachs, insomnia, etc.) to show up **if they were going to** in
those of the 50% who are taking the pills. IF no negatives show up, but
the 'hidden test group' has Improved control that is measurable, versus the
50% who are on their records as taking the 'sugar pill', and those haven't
changed, then we have a new pill which can help a certain group of people
having Absence type seizures.
They would Also be happy if they find a pill that improves things, since
many times it's more difficult to get a pill to work for Kids than for
Adults, since their weight is lower but changing more quickly as they age,
*and their Digestion rate (metabolism) tends to flush some types of pills
more rapidly from digestion or bloodstream than in us 'olde people'...
//

> I'd appreciate hearing other parents experience about medications,
> especially depakote, and if others are participating in this or similar
> clinical trials. Although there would be more follow up in the study
> and the doctor is well-regarded, I'm not sure the trade-offs are
> necessarily worth it. (The treatment alternative is another neurologist
> on the hosptial staff, whom we would see less often.)

** I didn't see this part until I had typed stuff above, so I'm not a parent
of a child with this. I also don't know how they'd coordinate this type of
test (since it could run e.g. 8 weeks or longer (January through early
March?), with her school work, *or if they'd wait as long as next Summer
before they did the tests, when she's not in school. //

> Finally, because her episodes, though several per day, are minor (i.e.,
> fluttering of eyelids for 2 seconds and then return to consciousness),
> I've wondered if not giving any meds is a viable choice. Since her
> grades are excellent, there does not appear to be any major problem now
> and most children in this situation will outgrow the seizures during
> teenage years.

**** That should be something you could discuss with the Doctor planning the
tests. My understanding was that Some types of seizures might be outgrown,
but not 100% of people who have them and not All seizure types.
*I'd expect (with no direct experience) that even if she's not conscious
of the 2 second 'absences', that they'd still affect her ability to learn
in school, or read assignments and schoolwork? Or perhaps she's
unconsciously developed workarounds that can skip over those absences as
they occur.

Keep us posted how you make out no matter what you decide, and how she
progresses. There are a few people around here with kids (although some of
them haven't posted for a while), and several of the Regulars, when they're
here, have had seizures in some form since Childhood. So they might have
experiences or opinions that might reflect how they might have felt about
these types of tests if they had been available when they were younger.
G./

> Thank you in advance for your help.
> David

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DadDavid - 26 Oct 2005 06:01 GMT

My apologies! Your understandable confusion was caused by gross misuse
of terms, which I pulled from the ether of other things I've read in
the last few days. That's what I get for writing from memory without
the disclosure forms (which were at home.) I will clarify. It is not
a clinical trial, but a randomized test of the three most commonly
prescribed RX for absence seizures: Zarontin, Lamictal, and Depakote.
Here is a link explaining the study from the coordinating hospital:
http://www.cincinnatichildrens.org/about/news/release/2004/2-epilepsy-grant.htm
It is described as double-blind, in that neither the doctors or
patients will know what medicine a child receives. If a child has
adverse side effects in the first 16 weeks, she can be weaned off that
medicine and placed on another medicine.

I hope this helps, and I certainly did not mean to limit responses to
parents only.

David W.

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Liz MacDonald - 26 Oct 2005 12:20 GMT

Hi David,
Two data points which may not help your decision any:
I tried Depakote. I put on 15 lbs in about 3 months and it didn't give
me any better control. The weight came back off once I stopped taking it.
I tried Lamictal. It increased my simple partials from 2 or 3 a day up
to a high of 14 a day. My dreams became extremely vivid. I developed
enlarged lymph nodes indicating a reaction to the medication. These
effects all disappeared within a couple days of stopping it.

Liz

> My apologies! Your understandable confusion was caused by gross misuse
> of terms, which I pulled from the ether of other things I've read in
[quoted text clipped - 13 lines]
>
> David W.

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DadDavid - 26 Oct 2005 18:13 GMT

Thanks. I'm struck by how widely these drugs seem to vary in
effectivenes depending upon the individual. Glad to know the weight
came off quickly. As I understand it, the weight gain is due more to
increased appetite than metabolism or other changes. I also have been
told there is a 30% chance of a tonic clonic seizure for my daughter so
doing nothing is not an option.

David

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DadDavid - 26 Oct 2005 18:13 GMT

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G.Ross - 26 Oct 2005 15:40 GMT

> My apologies! Your understandable confusion was caused by gross misuse
> of terms, which I pulled from the ether of other things I've read in
> the last few days. That's what I get for writing from memory without
> the disclosure forms (which were at home.)\

*G* Not to worry. It's one of the shortcomings of these 'primitive' posts,
capsizing a longer idea into short posts, where longer ones might not help
anyway, without clarification.
One advantage for you? of the study, is that the test appears to be set
to run for *4 years. You should still discuss your misgivings with the
Drs. (as well as here), but at least they'll be Watching her for that length
of time, on a Monthly? or 6-week frequency. (You might want to check
with them that no or few Needles (!! :-o ) or anything gross are needed as
part of the test. That would help your Daughter feel better about taking
part in it - at least it would help *me if I was the subject... )
At least now that you've listed the 3 main meds. they're testing *below
(for childhood use?), there are others around here who've posted about
those and used them. So now *they can comment wrt. their own experiences
with any of those, and if any have used them for treatment of absence szrs.
as well.
My description of Double Blind, and its reasons (so that neither
patient nor Doctor can inadvertently introduce biases as they don't know
which of the meds. was being used during a test), was approximately correct.
I had thought they had a New medication ready to launch, and the last step
on that process is usually a similar double blind test which you might have
had a chance to help with the steps that would enable a *new 'cure'..
*Did they explain why they are testing 3 medications that are already in
'common use' ?? Is it because these are new for treating childhood type
szrs. like absences? or will it find anything NEW that wasn't already in
the literature (of Medics) before? In other words is this the First time
these 3 have been compared in a Double Blind test, or are they just
repeating something that has been done elsewhere and been already documented
?? (My attitude might change if there's medical literature already
covering these, *unless they're looking for whether a longer time period
might help them work better than data they have currently. ) G. Now we
can see what some parents say... /

I will clarify. It is not

> a clinical trial, but a randomized test of the three most commonly
> prescribed RX for absence seizures: Zarontin, Lamictal, and Depakote.
[quoted text clipped - 9 lines]
>
> David W.

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DadDavid - 26 Oct 2005 18:09 GMT

As I understand it, there is not any well developed evidence as to
whether one of these drugs is necessraily better or if one is better
for certain indicators (blood work, severity of seizures, etc.) I've
located tests results from this and other countries confirming that.
Apparently, this medication is prescribed more on trial and error and
the side effects than anything else. The Dr. say there is a 50% chance
of weight gain with Depakote, but it generally has less cognitive side
effects than others. She also assured me that if we are not happy with
the drug she is on, they will take her off. So, I'm now leaning toward
participating, because as Howdy Dave notes, the level of follow up and
making it user friendly (appointment hours, waiting, etc.) will be
markedly better on the study. She will be poked with needles more
because they want to run blood tests to see if they can use that as
tool to decide which is the drug of choice for a given person. We can
always drop out of the study if that is a major problem.

Thanks for all of your and the others' comments. I realize this is
relatively a benign condition, but that does not prevent a parent's
worry.

David
dlwlra@yahoo.com

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> My apologies! Your understandable confusion was caused by gross misuse
> of terms, which I pulled from the ether of other things I've read in
[quoted text clipped - 3 lines]
> prescribed RX for absence seizures: Zarontin, Lamictal, and Depakote.
> Here is a link explaining the study from the coordinating hospital:

http://www.cincinnatichildrens.org/about/news/release/2004/2-epilepsy-grant.htm

> It is described as double-blind, in that neither the doctors or
> patients will know what medicine a child receives. If a child has
[quoted text clipped - 5 lines]
>
> David W.

Howdy David!

There is one thing about this opportunity...

No matter which drug your daughter gets, her seizure control will probably
be observed and documented by the doctor with much more precision that it
would be if the doc just treated her as a standard patient!

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