Retigabine (Trobalt, Potiga) — Petition to the ATA

[Markku]

As I think it was requested, attached are the Retigabine Forms results (as of November 21, 2014) in CSV format.

 

[Dr. Nagler]

As I think it was requested, attached are the Retigabine Forms results (as of November 21, 2014) in CSV format.

Markku, I apologize for not being clearer. (Lots going on in these threads.) I am looking for one or two unambiguous sentences summarizing Tinnitus Talk's anecdotal experience.

Once I have that from you, I will write up a draft of the proposed petition for comments.

I feel I need to add that I will not be signing it; I am just complying with the boards' general desire to get moving on this project.

Dr. Stephen Nagler

 

[NeverLoseHope]

Markku, I apologize for not being clearer. (Lots going on in these threads.) I am looking for one or two unambiguous sentences summarizing Tinnitus Talk's anecdotal experience.

Once I have that from you, I will write up a draft of the proposed petition for comments.

I feel I need to add that I will not be signing it; I am just complying with the boards' general desire to get moving on this project.

Dr. Stephen Nagler

Sorry my post was at the same time as yours. I am taking you at face value and guess you are a real Dr /GP if so you must know the dangers involved? I know people in the states like to sue people. but if you took the risk to endorse this I hope you have good insurance?

 

[Dr. Nagler]

Sorry my post was at the same time as yours. I am taking you at face value and guess you are a real Dr /GP if so you must know the dangers involved? I know people in the states like to sue people. but if you took the risk to endorse this I hope you have good insurance?

I'm not endorsing anything. Indeed, I said I myself would not sign the petition.

Moreover I do not believe a retigabine study will ever be done regardless of how many names appear on the petition. Given the side-effect profile of the drug at the doses needed to possibly mitigate tinnitus, there's not an IRB (Institutional Review Board) in the country that would approve.

Dr. Stephen Nagler

 

[valeri]

I am looking for one or two unambiguous sentences summarizing Tinnitus Talk's anecdotal experience.

unambiguous
ʌnamˈbɪɡjʊəs/
adjective

1. not open to more than one interpretation.
   "instructions should be unambiguous"

How realistic it is to ask for unambiguous sentence when it comes to trobalt being used for tinnitus?
If there is anything unambiguous about trobalt and tinnitus we wouldn't be asking for a further trial/study!
Please correct me if I'm wrong, with English being my second language I may have lost the meaning of the request

 

[Dr. Nagler]

How realistic it is to ask for unambiguous sentence when it comes to trobalt being used for tinnitus?
If there is anything unambiguous about trobalt and tinnitus we wouldn't be asking for a further trial/study!
Please correct me if I'm wrong, with English being my second language I may have lost the meaning of the request

The petition would ideally result in a double-blind randomized prospective study funded by ATA. (I do not think that will ever happen because of the IRB issues I mentioned above.) What I am asking for in order to prepare a draft of such a petition is a clear statement summarizing our anecdotal experience.

Stepping back for just a minute, I hope folks following this discussion are beginning to get an appreciation of the futility of this endeavor and why @Markku has been pessimistic from the start, appropriately so in my opinion.

Dr. Stephen Nagler

 

[valeri]

Why don't we just forget it then?
That's easier and it will keep ATA and all other broads happy.
Meanwhile we can continue to suffer, wallow in our misery and hope for almighty to come up with something for us.
No more comments from me, unless you need few hundred signatures I'm out of this back and forth discussion

With this much pessimism no wonder every other attempt failed!

 

[Dr. Nagler]

Why don't we just forget it then?
That's easier and it will keep ATA and all other broads happy...

ATA will be happy when there's a cure for tinnitus.

Dr. Stephen Nagler

 

[RCP1]

Unfortunately we are a few years away from a cure. Autifony starts its trials this month and God speed to them. The folks who are or have been taking trobalt have done so at their own risk and weighed up the risk and reward element themselves. With this condition you are essentially alone. We are all in a battle against time to save our lives and sanity. It is no joking matter. Having T is an every man for himself scenario whereby each individual strives to find a therapy or treatment that will allow them to prolong their lives. We all have opinions based on our own situation in terms of what will work best if anything. At this point and for those with distressing T it is not really an option to wait for years while the cure is discovered either by accident or design. We are hanging off the side of a cliff now and we are grappling with whatever tools we can get our hands on to either climb back up or safely glide down. The reality is though that for most of us the solution will be to continue hanging on until our fingers can no longer take the strain. I for one am in admiration for those that take the decision to jump when the below tide seems to swell and maximise their chance of survival while they still have the strength to partially determine their fate.

 

[preslys]

Here are the steps to create a petition

1-Researching Your Cause:

- Verify that a cause for petition falls under your local government's jurisdiction
-Find out how many signatures you need
-Learn how people must sign the petition for it to be valid
-Research your topic so you understand the various positions fully
-Consider which medium for circulating your petition is ideal

2-Writing the Petition:

-Develop a very specific statement that identifies what you want people to support
-Make your petition brief
-Add body paragraphs supporting your first, declarative paragraph

-Read over your summary carefully
-Edit your petition for spelling and grammar errors
-Get someone else to read your petition, preferably a friend or relative who is uninformed about the situation

3 -Creating the Signer's Form

- Create a signer's form on a separate sheet of paper
-Prepare the form using a spreadsheet program
-Photocopy or print multiple copies of your original

4-Promoting Your Petition:

- Use the power of e-mail
- Create an online presence for your petition
-Talk to people in person
-Get media coverage
-Be polite

 

[amandine]

why dont we just create one petition and direct it to the World Health Organisation as it is a global problem?

If we approach govts separately then it will take for ever and each petition will have its own number of signatures.
We need to join together globally which is not impossible these days is it? and get ALL the signatures on ONE petition.
Just my thoughts on this.....

For example: https://www.change.org/p/world-heal...health-act4iraq-and-release-birth-defect-data

and https://secure.avaaz.org/en/petitio...nquiry_about_the_safety_of_medical_mesh/?pv=0

and
https://www.communityrun.org/petitions/worldwide-rsd-crps-awareness-campaign-1

and
http://www.tnnme.com

or this one
https://www.boehringer-ingelheim.co...eases/2012/22_may_2012_1_mission1million.html

The WHO is a political organisation. Look how quickly they got the ebola treatment pushed forward - probably cos govts feared the financial effects if this disease spread globally. Look how much money has now been given to the ebola problem.

Look also how many neurological ailments have no cure and are basically being ignored.

 

[Christian78]

Let me explain. No, there is too much. Let me sum up.

@Johno -- some improvement, improvement sustained after temporary withdrawal from the drug
@SoulStation -- slight improvement, currently withdrawing due to side effects
@Viking -- slight improvement, withdrew due to (pre-existing?) kidney condition
@Christian78 -- significant improvement despite many side effects
@Bogdan -- significant improvement
@Hengist -- withdrew due to side effects
@Mpt -- practically cured, sustained benefit after fully withdrawing from drug
@Zimichael -- super-chronic case; no improvement, withdrew due to supply problems, conflict in scheduling with dental surgery
@Freddie -- decided not to start treatment in hopes of enrolling in Autifony trial
@undecided -- significant improvement, many side effects
@locoyeti -- significant improvement
@Danny Boy -- significant improvement
@NGC891 -- super-chronic case; just started, has not updated
@Philemon -- just started
@Juan Carlos -- just started, slight improvement
@Ricardo -- "cured" (his quotations) but suffered renal failure, withdrew quickly and tinnitus returned within three weeks; no previous history of kidney problems

@Lep -- withdrew due to side effects, tried again months later, no improvement, remained at low dose due to side effects

Except for Lep's saga, that is all from the User Experiences thread.

You can see just from that brief summation that it is far from a clear case, but there is certainly something going on. I should add that anybody you see in that list who was able to increase their dosage to > 600mg reported at least a slight improvement (post if I'm wrong, please). I believe even SoulStation had some improvement before deciding that his side effects, combined with Ricardo's experience, made it not worth it.

So, interestingly, we've had two people cured and two people who sustained the benefits of their usage after withdrawing from the drug. Unfortunately, they are not the same people. Mpt was cured and sustained, Johno got some improvement and sustained, and Ricardo was cured and did not sustain. We have discussed already Ricardo's case. He had to withdraw rapidly from Trobalt due to his renal failure, so it seems reasonable to conclude that his brain had not had time to consolidate the homeostatic adaptation that would have allowed him to sustain his benefit. He deserves our sympathy twice over for having been slapped by the front and the back hand of misfortune.

All things considered, here's how I run the numbers.

Total participants: 17
Participants who withdrew before 600mg (dosage considered minimal for epileptics): 3 (Viking, Hengist, and Lep)
Participants who have not yet reported after being >= 600mg for at least one week: 4 (Freddie, NGC891, Philemon, Juan Carlos)

Sub-total excluding the above: 10
Participants in the sub-group reporting no improvement: 1 (Zimichael)
Participants in the sub-group reporting slight improvement: 1 (SoulStation)
Participants in the sub-group reporting some improvement: 1 (Johno)
Participants in the sub-group reporting significant improvement: 5 (Christian78, Bogdan, undecided, locoyeti, Danny Boy)
Participants in the sub-group reporting complete improvement (practically cured): 2 (Mpt, Ricardo)

Total participants in the sub-group reporting some or greater improvement: 8

Participants who retained improvement after withdrawing completely from retigabine: 2 (Mpt, Johno)
Participants experiencing major short-term side effects (continual interference in day-to-day life) that went away after discontinuing retigabine: 6 (Hengist, Lep, Zimichael, SoulStation, Christian78, undecided)
Participants experiencing major long-term side effects (with good reason to attribute to retigabine use): 1 (Ricardo)

And a further summation:

Total participants reporting after taking 600mg for at least 1 week: 10
Total participants of that group reporting benefit: 9
Total participants reporting major long-term side-effects: 1

Hopefully Ricardo will be given a clean bill of health. To me, these are pretty fantastic numbers. They are tricky because the actual stories are so much more complex, but if you want to know how many people experienced noticeable improvement in their tinnitus after increasing to a minimal therapeutic dose, it's 9/10. How many think it was worth the side effects? More like 7/10 (excluding Zimichael who had no improvement, SoulStation due to major short term side effects and Ricardo).

Hope this is useful.

I am not reporting significant but VERY significant results.

 

[rtwombly]

I am not reporting significant but VERY significant results.

This is great to know. We got so much into talking about side effects on the main thread I think many people forgot that the beneficial results are not placebo, and in several cases have been good enough to be (if you don't mind such a dramatic phrase) life-altering.

 

[Martin69]

Let me explain. No, there is too much. Let me sum up.

@Johno -- some improvement, improvement sustained after temporary withdrawal from the drug
@SoulStation -- slight improvement, currently withdrawing due to side effects
@Viking -- slight improvement, withdrew due to (pre-existing?) kidney condition
@Christian78 -- significant improvement despite many side effects
@Bogdan -- significant improvement
@Hengist -- withdrew due to side effects
@Mpt -- practically cured, sustained benefit after fully withdrawing from drug
@Zimichael -- super-chronic case; no improvement, withdrew due to supply problems, conflict in scheduling with dental surgery
@Freddie -- decided not to start treatment in hopes of enrolling in Autifony trial
@undecided -- significant improvement, many side effects
@locoyeti -- significant improvement
@Danny Boy -- significant improvement
@NGC891 -- super-chronic case; just started, has not updated
@Philemon -- just started
@Juan Carlos -- just started, slight improvement
@Ricardo -- "cured" (his quotations) but suffered renal failure, withdrew quickly and tinnitus returned within three weeks; no previous history of kidney problems

@Lep -- withdrew due to side effects, tried again months later, no improvement, remained at low dose due to side effects

Except for Lep's saga, that is all from the User Experiences thread.

You can see just from that brief summation that it is far from a clear case, but there is certainly something going on. I should add that anybody you see in that list who was able to increase their dosage to > 600mg reported at least a slight improvement (post if I'm wrong, please). I believe even SoulStation had some improvement before deciding that his side effects, combined with Ricardo's experience, made it not worth it.

So, interestingly, we've had two people cured and two people who sustained the benefits of their usage after withdrawing from the drug. Unfortunately, they are not the same people. Mpt was cured and sustained, Johno got some improvement and sustained, and Ricardo was cured and did not sustain. We have discussed already Ricardo's case. He had to withdraw rapidly from Trobalt due to his renal failure, so it seems reasonable to conclude that his brain had not had time to consolidate the homeostatic adaptation that would have allowed him to sustain his benefit. He deserves our sympathy twice over for having been slapped by the front and the back hand of misfortune.

All things considered, here's how I run the numbers.

Total participants: 17
Participants who withdrew before 600mg (dosage considered minimal for epileptics): 3 (Viking, Hengist, and Lep)
Participants who have not yet reported after being >= 600mg for at least one week: 4 (Freddie, NGC891, Philemon, Juan Carlos)

Sub-total excluding the above: 10
Participants in the sub-group reporting no improvement: 1 (Zimichael)
Participants in the sub-group reporting slight improvement: 1 (SoulStation)
Participants in the sub-group reporting some improvement: 1 (Johno)
Participants in the sub-group reporting significant improvement: 5 (Christian78, Bogdan, undecided, locoyeti, Danny Boy)
Participants in the sub-group reporting complete improvement (practically cured): 2 (Mpt, Ricardo)

Total participants in the sub-group reporting some or greater improvement: 8

Participants who retained improvement after withdrawing completely from retigabine: 2 (Mpt, Johno)
Participants experiencing major short-term side effects (continual interference in day-to-day life) that went away after discontinuing retigabine: 6 (Hengist, Lep, Zimichael, SoulStation, Christian78, undecided)
Participants experiencing major long-term side effects (with good reason to attribute to retigabine use): 1 (Ricardo)

And a further summation:

Total participants reporting after taking 600mg for at least 1 week: 10
Total participants of that group reporting benefit: 9
Total participants reporting major long-term side-effects: 1

Hopefully Ricardo will be given a clean bill of health. To me, these are pretty fantastic numbers. They are tricky because the actual stories are so much more complex, but if you want to know how many people experienced noticeable improvement in their tinnitus after increasing to a minimal therapeutic dose, it's 9/10. How many think it was worth the side effects? More like 7/10 (excluding Zimichael who had no improvement, SoulStation due to major short term side effects and Ricardo).

Hope this is useful.

Excellent summary. Keep up the good work.

 

[Dr. Nagler]

We got so much into talking about side effects on the main thread I think many people forgot that the beneficial results are not placebo ...

Just some perspective here ...

A number of individuals on this board are of the firm belief that the effect of Retigabine on tinnitus is pharmacological and not placebo. If we knew that the effect were pharmacological and not placebo (i.e., if the drug were actually tested against a placebo in a properly blinded study), then physicians would willingly prescribe it for their patients off label. That's the whole point of this thread. Or at least I thought it was.

Dr. Stephen Nagler

 

[rtwombly]

Well put, @Dr. Nagler.

 

[beemovie]

Dear Markku,
I apologise for being a pain in the neck or a..
but the following post from Dan got my attention and I think it's worth perusing:

"@valeri , ok you asked me once -what can WE do as T sufferers.
Ok so its a no-brainer that Retigabine does seem to have a positive effect on tinnitus. So why don't we all on TT forum, sign an electronic petition to the ATA demanding a trial with Retigabine for tinnitus, so that it will be no longer OFF-LABEL for us poorsouls. So it will be recognized as a treatment option of last resort after say anti-depressants, but will nothave to beg for it."

I'm not the best writer or beat around the bush person so here it goes:

Markku as a leader of this board I think that your guidance, with our help of course, is absolutely critical for this idea to see a daylight.
As you know the retigabine thread has a great interest of us tinnitus sufferers and I think it's unacceptable that this drug had never been trialed for tinnitus per se.
Being available on the market is a huge bonus, it just needs to be made available off label for tinnitus.
After some testing of course. No one so far had life threatening or permanent side effects, that's promising.
Even my gp, upon checking his medical info on computer, said that this drug can help tinnitus.
Not sure what other members think about this idea but I would like to hear some opinions or suggestions.
Over 4000 signatures from this board alone is not a small number, I'm sure people are members of other forums or groups, so we are talking many more.
I can get hundreds alone from my friends and the whole dental hospital if needed
I don't think it's too much to ask.
Markku can you please not move this thread from support section, it seems that awareness and funding section doesn't get the same attention.
Fire away TT members!

Doing a medical study on any drug is not a easy task. It can be done but it would be expensive given all the things that would needed. Also, when drugs become available as generic (I not sure if this drug is or not), the original manufacturer generally does not bother spending money on trials themselves.

 

[beemovie]

Would GSK fund further trial since it's their drug?

@Dr. Nagler
Valid point but it goes back to supply issue, I'm sure many more on this board would have tried if it was readily available.

I doubt it. But if they really want to, they could make a new drug by tweaking it and saying it is for tinnitus. They would have to go through the motions to try and get it approved. I think it all comes down to if they can really prove it will work on tinnitus and if it is worth the money for them to bother.

 

[lapidus]

I doubt it. But if they really want to, they could make a new drug by tweaking it and saying it is for tinnitus. They would have to go through the motions to try and get it approved. I think it all comes down to if they can really prove it will work on tinnitus and if it is worth the money for them to bother.

But arent the researchers in Pittsburgh already doing something like that? They are trying to tweak Retigabine so it have lesser side effects and they talked about treating acute T with it.

http://www.dailymail.co.uk/health/a...TINNITUS-reduces-hyperactivity-cells-ear.html

 

[beemovie]

But arent the researchers in Pittsburgh already doing something like that? They are trying to tweak Retigabine so it have lesser side effects and they talked about treating acute T with it.

http://www.dailymail.co.uk/health/a...TINNITUS-reduces-hyperactivity-cells-ear.html

I just looked at the the linked article. It says that "The researchers found that mice that were treated with retigabine immediately after noise exposure did not develop tinnitus". Looks like they were saying it could work to prevent tinnitus from happening. It does look like a step in the right direction. My thoughts are still that any calming of T in the future will end up coming from a pill. But......someone posted on the comments that "These drugs make you feel so ill. They take your memory, make you dopy an sluggish. I wouldn't wish them on anyone"


On another note, are you any relation to Frank J. Lapidus?

 

[MattK]

Forgive me all for not keeping up on this. But isn't Autifony already supposed to be like a more specific retigabine? If so, then why exactly do we need a study on retigabine if we've got Autifony? I haven't done much research, but based on the "bits and pieces" I have read, it sounds like retigabine is supposed to be the inferior version of Autifony.

 

[Telis]

Forgive me all for not keeping up on this. But isn't Autifony already supposed to be like a more specific retigabine? If so, then why exactly do we need a study on retigabine if we've got Autifony? I haven't done much research, but based on the "bits and pieces" I have read, it sounds like retigabine is supposed to be the inferior version of Autifony.

Yeah agree. I posted that earlier in this thread.

 

[Dr. Nagler]

Yeah agree. I posted that earlier in this thread.

OK. No need to move ahead with the Retigabine petition. You'll get no argument there from me.

Kindly let me know if you wish to revisit this issue at some point in the future.

Best to all -

Dr. Stephen Nagler

 

[dan]

But arent the researchers in Pittsburgh already doing something like that? They are trying to tweak Retigabine so it have lesser side effects and they talked about treating acute T with it.

http://www.dailymail.co.uk/health/a...TINNITUS-reduces-hyperactivity-cells-ear.html

I don't think you get it, with all due respect.
Right now, ......right NOW - we have nothing. Zero, zilch, nada.
What we do have is an APPROVED epilepsy drug (Trobalt) that reduces tinnitus in 80-90% of people.
If they tweak or shmeak the drug (which could take years), then its no longer approved and it has to go through aaaaaaaaallllllllllll the clinical phases.
Autifony, may or may NOT be approved. So what do we have in the end?
A BIG FAT NOTHING.
So let's turn Trobalt's label from just epilepsy, to epilepsy and TINNITUS.

Am I clear or need more clarification.

 

[valeri]

@dan

If that wasn't clear than I don't know how much clearer anyone can make it

 

[lapidus]

I don't think you get it, with all due respect.
Right now, ......right NOW - we have nothing. Zero, zilch, nada.
What we do have is an APPROVED epilepsy drug (Trobalt) that reduces tinnitus in 80-90% of people.
If they tweak or shmeak the drug (which could take years), then its no longer approved and it has to go through aaaaaaaaallllllllllll the clinical phases.
Autifony, may or may NOT be approved. So what do we have in the end?
A BIG FAT NOTHING.
So let's turn Trobalt's label from just epilepsy, to epilepsy and TINNITUS.

Am I clear or need more clarification.

Aah okay, then I get it. I thought the dudes in Pittsburgh actually was doing what you guys wanted someone to do.

 

[MattK]

I don't think you get it, with all due respect.
Right now, ......right NOW - we have nothing. Zero, zilch, nada.
What we do have is an APPROVED epilepsy drug (Trobalt) that reduces tinnitus in 80-90% of people.
If they tweak or shmeak the drug (which could take years), then its no longer approved and it has to go through aaaaaaaaallllllllllll the clinical phases.
Autifony, may or may NOT be approved. So what do we have in the end?
A BIG FAT NOTHING.
So let's turn Trobalt's label from just epilepsy, to epilepsy and TINNITUS.

Am I clear or need more clarification.

Ok, got it. Well, I think the best course of action would be to try to convince a doctor to prescribe it, perhaps by using Dr Nagler's advice. That'd be much faster and probably easier than trying to petition for it to get a double blind test and then rebranded to help tinnitus. And even if petitioning for it to be tested worked, what if it fails?

Basically I think your time would be better spent doctor hopping until you find one that you can convince, rather than going this route.

 

[OnceUponaTime]

Can someone direct me to the Rotigabine study/file online that claims it helps Tinnits so that I may print it and take it to my doctor? Thanx a bunch.

 

[Zimichael]

Can someone direct me to the Rotigabine study/file online that claims it helps Tinnits so that I may print it and take it to my doctor? Thanx a bunch.

Numerous mentions on the Retigabine thread and even a pdf file I think of the best one. It may take some searching but it's all in there.
Note though that this is an "epilepsy" drug and the tinnitus aspects are "inferential". Hence the need to make them less of an inference by trying the stuff with more people willing to give it a go - and hopefully, with more of a 'controlled' element, etc., etc.

If such a "study" does not get off the ground then the sheer weight of numbers may make somewhat of a dent in acceptance that something is indeed going on if the majority of trialees get positive "tinnitus effects". The larger the number (N sample) the more unlikely effects can be discounted purely as "noise" or placebo.
However, as with any drug, do fully familiarize yourself with the risks and cautions.

Best of luck with your doc. Zimichael

 

[MattK]

How have people been getting retigabine? Did they really convince their docs to prescribe it?