husband's Seizure Medication Quandary

[gcvmom]

husband takes medication for simple partial seizures which cause sensory or autonomic symptoms for him. He's only lost consciousness from this once, about 5 or 6 years ago, but it was while he was driving, and frankly that's enough. We found out why he was having them and he had surgery, but he still has the seizures. He's on his second seizure medication, Trileptal, and the seizures are not 100% under control. It's a relatively minor incovenience, but sometimes it can be upsetting for him when these happen. And this week he's been experiencing episodes of tunnel vision without the usual aura and seizure symptoms.

His neuro said there's room to move him up in dosage, but the doctor doesn't want to increase it because he doesn't think it will help , and he thinks it will just make husband more tired than he already is from the medication.

So he recommended some other drugs, but in the same breath explained why they probably wouldn't be a good fit for husband (and we agreed). Then he starts to tell us about a drug trial for a new seizure medication and leaves us with that as our final thought.

A few weeks have gone by, and today we get this phone call from the neuro's nurse and she's asking husband if he's interested in participating in this drug trial. It's a double-blind study (so to me that means he COULD get a placebo). The drug is not yet on the market. There is no financial compensation, but the hospital would pick up all the visits, labs and follow-up care costs over a 4 to 4.5 month period. They said husband meets the criteria for the study (I'm assuming it's refractory seizures after two or more medication trials). The drug has already been tested in the EU, Japan and Australia (maker is UCB). Side effects he jotted down are sleepiness (already a problem with Trileptal) and headaches.

Just yesterday I'd told him I thought he should look for another neuro to manage his medications, and try to find one who would support at least TRYING to increase his Trileptal to see what happens (he's on 1800mg/day). And then we get this phone call.

I'm a little bit leery about having him go through this when I don't feel like we've given Trileptal a thorough trial. He was originally on Lamictal, which worked really well, but he got a rash and the doctor was really goosey about him risking Stevens Johnson syndrome. Fair enough. Something in my gut feels like this neuro is just trying to shoe-horn husband into the study without really giving his current treatment a fair chance.

Now, since husband is out of work right now, it would sort of be okay if it turned out to be placebo. But if he gets a job in the next few months, that might really be problematic if he starts having seizures again, or if he has a bad reaction to the drug.

SO... here's my question: Do we skip the drug trial and go find a new neuro who will let us try a higher dose of Trileptal? Do we go for the trial in hopes that the new medication will work (and that husband doesn't get a placebo)? Do we try one of the other suggested though not preferred drugs? Do we just keep the status quo and have him put up with occasional mild seizure episodes?

 

[susiestar]

I am torn about studies. I qualify for a lot of them but they always want me to stop all my other medications, even estrogen and thyroid. not happening.

The side effect lists are scary, but they are for most drugs, even OTC one.

Will the new drug be available to him after the study? or will he take the medication, and then have to find a new one after the study is over, even if the medication helped him a LOT?

What if the medication works really really well and when the study ends he has to find a new medication? How will that affect a new job? does he have a LOT of seizures when he is changing medications?

Be aware that running drug trials is a very very lucrative job. If the doctor is part of the team running the trial he will get compensated very well if your husband goes into the study. Even if he is NOT part of the docs running the study he will still get compensation if your husband starts the trial, and more if husband finishes it.

If your instincts say you need to try other things before this, I think that says a LOT. Personally I think the gut of a Mom/Wife who knows a few things about medications (like all Warrior Moms with difficult child's) is vastly more reliable than a doctor or three.

 

[rlsnights]

So, this is the only study listed at Clinical Trials.gov for partial seizures that is from UCB.

http://clinicaltrials.gov/ct2/show/NCT00955357?recr=Open&cond=%22Epilepsies,+Partial"&rank=21

The study description doesn't match your husband's description - it's open label, single group with the medication (Vimpat) used as an add on medication to first AED. Irvine, CA is listed as one of the locations.

The drug maker is UCB. I couldn't find any other study by UCB that was placebo, double blind randomized.

It does appear that the medication is not available after the trial through the maker because the description includes a 3 week taper period. However, this drug is already on the market so ??? It's a schedule V controlled substance but it is available.

Nothing in the posted info about an extension phase although I suppose that might be coming down the pike depending on the results.

Are you familiar with the Crazy medications website? If not here's a link

http://www.crazymeds.us/

You might want to cruise through the info about seizure medications. Says max dose of Trileptal is 2400 in 300 mg increments. Also says it's not as powerful as Tegretol. So there's not a lot of room to go up on the Trileptal from where he's at now. Has he tried playing with dosing - I assume he's doing split doses. Does it makes sense to do 3 times a day or to do more in the morning vs. evening? It has a pretty linear and short half life in two passes with the longest being 9 hours.

I understand the docs concern about SJS but if Lamictal worked really well and he didn't actually develop SJS I might be tempted to ask about adding a small dose of Lamictal to the Trileptal. Just a thought.

Hope you find some answers soon.

 

[DammitJanet]

I so agree with rls.

 

[gcvmom]

Susie, I suppose once the drug is on the market it would be available to him. Which would mean he'd have to go back to Trileptal until it finally is available. He hasn't tapered off seizure medications since starting them about two years ago so I'm not sure how he'd do if he weaned off slowly. He DID go cold turkey one weekend when we accidentally ran out, and that resulted in some pretty bad seizures that left him wiped out for a few days.

There is the potential for his QOL to be really messed up for a while from this. And not just seizure-wise, but also his mood since we KNOW the AED's have helped him (and even he admits it now).

The whole financial aspect of a doctor's motivation for a trial REALLY bugs me, to be honest. I am very suspicious of someone's ability to remain unbiased when they are getting paid to make a specific recommendation for care.

....

Patricia, as always, you are a wellspring of information The study starts next month. I don't know if there's a lag time with the gov't posting study info, but for sure this medication is not on the market yet so I don't think it's Vimpat. I'll read more at the crazy medications site. I also need to check my notes because the doctor was rattling off different drug names last time, many I'd never heard of. I may have jotted it down.

I think the BIGGEST issue for me is the prospect of him getting the placebo, and then having to live with seizures AND a breakdown in his mental health. With what we've been through in the past, it just does not seem worth the risk, especially when we haven't TRIED to increase Trileptal and haven't even considered something like what rls suggests in adding back a small amount of Lamictal to see if that helps. This doctor is just not thinking creatively enough for my liking.

Thanks for the feedback, ladies. It is so very helpful!

 

[rlsnights]

I believe that all double blind studies in patients (as opposed to healthy individuals) have an escape clause for patients that experience a worsening of their condition while in the study. Usually there's an intermediate step where you switch to open label and increase or modify the dosing conditions in some way and then quitting if that still doesn't work. You can thank the AIDS movement activists for that shift in the status quo.

So, yes, it would not be great if he got placebo but generally such a study is focusing on decreasing frequency/degree of sx and doesn't get approved by Human Subjects if there's no option for patients who get worse to be treated.

Plus you can ALWAYS quit the study at any time.

 

[Hound dog]

I've considered using studies..........and never gotten any further in it than that. husband used to work for a drug company, so I understand how important these studies are........but uh, just never have found one that sat well with me.

There are many seizure medications out there for husband to try if the trileptol isn't working well for him. Travis used Carbitrol for years with no sleepiness side effect and it did pretty darn well at controling his seizures. Of course he was on a pretty high dosage as well, especially for a child.

If you don't feel the neuro is listening to you or meeting husband's needs, then maybe it's time for a new opinion.

As I've understoon it from Travis' neuros and even my step dad when he was alive (he had epilepsy and narcolepsy), it's not uncommon to have to try and find a "fit" with the seizure medications.

Hugs

 

[gcvmom]

Patricia, that's good to know. Yeah, I can just imagine telling someone -- oh by the way, if you get the placebo, just be prepared to die. You're right, they can't force him to participate if things go sour.

I just don't think it's worth the aggravation... for ME anyway! He and I need to talk about this some time this weekend. He got the call yesterday and there's been no time to chat uninterrupted. I laid down at 5pm yesterday to take a nap and woke up at 7 this morning... I guess I was tired!

 

[gcvmom]

Lisa, that's exactly how I feel -- the neuro's not listening! I'm leaning towards looking for someone else. We might go back to his neurosurgeon (at a different hospital) and ask for a recommendations.

 

[Lothlorien]

I think you are on the right track gcv. I would be concerned about him having seizures on a placebo. If they are fairly under control, then he's not having them regularly. If he's on the placebo and has a seizure, hits his head and suffers brain damage, then what? No thanks, not for me. I'd be looking into another neuro.

How is he getting back and forth to work, now? He's not driving now, right?

 

[gcvmom]

Loth, he's still unemployed, and he does drive because these are very mild, non-convulsive, non-consciousness-altering events.

After talking to him last night, he says there is no placebo in the study, just a different dosing schedule for each patient. I'm confused, and didn't think studies were conducted this way, but then I didn't talk to the nurse who gave him the info. (And then again, husband often mishears or misunderstands medical jargon, so who knows?)

I told him he needs to find another neuro for a second opinion, and that we should contact his neurosurgeon for a referral at the hospital where he had his surgery (and in my humble opinion, it's a MUCH better facility both in the level of care and the caliber of its staff -- whereas the other, although it's a teaching hospital, just does not impress me).

So I think we're just going to pass on the study and start looking for a new neuro.

I appreciate everyone's candid advice here. It is such a blessing to have you all to share your collective experience and knowledge with us.