New therapies for RLS!! New research finally!

[beartoothgirl406]

I have had RLS for 30 years, but when prescribed pramaprexole, of course, it made the monster worse. I did some research and there are two new therapies coming out.

One is a new drug discovered by professor Dr. Stefan Clemens at Brody school of medicine...he discovered why augmentation happens...the dopaminergic drugs actually stimulate dopamine subtype D!. This is HUGE NEWS! They are about to start the second trials.

He emailed me immediately which was amazing. He told me about a new therapy that may work very well until his drug, Ecopipam, is released by Emalex Biosciences. It is called DeNovo and it is a band you wear on your legs which electrically activate the peroneal nerves bilaterally to produce tonic, sustained muscle activation that is compatible with sleep to suppress symptoms of RLS.

I have been on many chats and have done lots of research, but these two are big breakthroughs in science.

I am on a waiting list for the DeNovo product and have high hopes for Ecopipam. I am 62 and hoping that the drug comes out soon.

I also take Low Dose Naltrexone. I took it years ago and got down to .15 MG of Pramaprexole. for some reason I stopped taking it and of course things got much worse. Last night was my second night taking it. Just with the first dose two days ago, I had ZERO breakthrough in the middle of the. night, and I could sit and watch TV after dinner and not be pacing the floor.

Do yourself a favor and look into both. I'll share an article on Stephan Clemens.

news.ecu.edu/2022/04/07/ecu...

[beartoothgirl406]

noctrixhealth.com

this is the link to the DeNovo device

[ChrisColumbus]

Interesting!

[ChrisColumbus]

Noctrix has been mentioned here before - Hidden 's was the most recent before yours:

healthunlocked.com/rlsuk/po...

[LotteM]

Ecopipam is also mentioned before. Don't remember, but the research was published 2 (-3?)? years ago. Shall have a look and add the link later. But it never hurts to be reminded. I am not as optimistic as you, though. Still no cause or cure.

Here is the link to the earlier (2 yrs ago) post by Joolsg referring to the info about the study and its results at rls.org: healthunlocked.com/rlsuk/po...

[Joolsg]

healthunlocked.com/rlsuk/po...

I've been following Dr S. Clemens trials for a while. If Ecopipam stops augmentation, it will be the Holy Grail of RLS treatment.

The De Novo product is only available in the USA on prescription. I asked the manufacturers if it would be licensed here in the UK, but there are no plans yet.

We have a similar device, a lot cheaper, called Therapulse, which a few members, including Elisse Pippins2 have found helpful.

LDN is only available on private prescription in the UK, but several previous members reported that it helped.

Let us know what you think of the De Novo.

[beartoothgirl406 in reply to Joolsg]

LDN really works and is worth getting a script. Years ago I was hardly taking any pramaprexole. The only downside is I get sick if I have a cocktail. Not a big drinker so it doesn't really matter...

[Joolsg in reply to beartoothgirl406]

Have you tried to get off Pramipexole?I know it's tough, but the severe RLS would disappear if you can get off it. You wouldn't need to go through the withdrawal every so often by halving the dose, then restarting.

Many of us have been through withdrawal and found meds that cover our RLS. I take low dose Buprenorphine, others take pregabalin. A lucky few are med free after iron infusions.

[beartoothgirl406 in reply to Joolsg]

thank you for that info! My iron is at good levels per my functional medicine doctor. Unfortunately I inherited it from my dad...so how do you exactly get off of it? I'm sure the schedule is different for everyone. You're right because it only happened if I wanted to stay up late to watch a movie, then the meds and now it's terrible. So you half it for awhile, then go to whole dosage, then keep at a half longer and longer?

[Joolsg in reply to beartoothgirl406]

The schedule is the same for all of us. First, get your actual serum ferrritin and serum iron numbers. Your doctor will tell you they are fine/normal but for RLS patients, they have to be way higher.

Next, start reducing pramipexole by dropping one half of a 0.088mcg pill every 2 weeks. The RLS will flare up so you may need a low dose opioid to help settle symptoms.

Start pregabalin or gabapentin about 4 weeks before your last dose.

Just read all Suejohnson replies and she sets out the schedule for reducing pramipexole and starting gabapentin/pregabalin.

As you're in Montana, you may find it difficult to find an expert in RLS. Join rls.org and they have local help groups. Dr Andy Berkowski in Ohio is excellent,

[beartoothgirl406 in reply to Joolsg]

Opioids scare me. Really? Is it necessary. Can I become addicted? Are those two medications necessary or just help with withdrawal symptoms? I will definitely do the iron and look at Dr. Berkowski. If it works why isn't everyone doing it? Thanks for steering me in the right direction.

[Simkin in reply to beartoothgirl406]

Hi Beartooth Girl. A very appropriate name for someone who lives in Montana!Although we visited Yellowstone in May & didn't see one bear!!

Re opioids. I am now in my 70s & have tried everything under the sun & the only thing that works for me is buprenorphine. A very low dose.

Plus therapulse, as mentioned, brings huge relief.

[Nanpat in reply to Simkin]

hi, just wondering what dose you take and how long you’ve been taking?

I’ve developed an opioid induced bowel problem from my time on them, Bup was a dream med for me for about 4 mths only.

will be posting shortly asking for help and suggestions as I need to seek other medication

Hope your relief continues

[Simkin in reply to Nanpat]

I have been taking buprenorphine for exactly 4 months.Oh dear, I don't like the sound of a possible bowel problem?

I take sublingual SF 200 mcg.

[Nanpat in reply to Simkin]

Hi, no no don’t worry! I’ve been on it a year and targin before that for many years.

It’s a problem that can apparently develop from long term use of opioids…….Therein lies my problem, what to do know??

Will be asking the regulars here for advice soon

You’ll be fine

[Simkin in reply to Nanpat]

Ok. Tx.

[Joolsg in reply to beartoothgirl406]

Iron does work for many. If it is given as first treatment, before dopamine agonists damage our dopamine receptors. A healthy dopamine system is needed to take up iron in the brain. Dr Buchfuhrer thinks that years on dopamine agonists cause permanent damage to the dopamine receptors.Many doctors still think iron infusions are dangerous and unsafe. In the past they were, but newer formulations have a much better safety profile. Also, most doctors are completely unaware of the link between RLS and low brain iron. That's why everyone isn't doing it.

I suspect that in 10 years, an iron infusion will be routine treatment for RLS.

Opioids have received a really bad press, quite rightly, because of the over prescription for minor pain, particularly in the USA. The addiction crisis is very real.

However, at low dose for RLS, opioids do not cause tolerance or addiction ( unless there is a history of drug abuse). Dr Winkelman's Opioid study is confirming this. Most RLS patients stay on the same, very low dose, for decades.

Pregabalin and gabapentin are epilepsy drugs, but they work for RLS. They are listed as first line drug treatment in the Mayo algorithm.

However, they don't start to work until around 3 weeks after the last dose of dopamine agonists. That's why most people need an opioid to settle the severe dopamine agonist withdrawal symptoms.

If you use the opioid ( codeine, hydrocodeine, tramadol, oxycodone) for a few nights after each dose reduction, they can really help.

Then, when off dopamine agonists, you can see if pregabalin or gabapentin cover your symptoms. If not, your doctor will consider methadone or Buprenorphine.

But raising your serum ferritin above 100, preferably 200, will help reduce augmentation and your RLS symptoms.

[TheDoDahMan in reply to beartoothgirl406]

As regards fear of opioids, the dosages involved in suppressing the RLS symptoms which keep us awake, are so low that tolerance seldom, if ever, occur. I've been prescribed low-dose (10 mg/day) methadone for over 4 years without a need to ever increase the dosage.

I'm 78 and since there seems to be no cure for RLS, will probably be on this prescription for the rest of my life. So what? Fear of opioid abuse has been pumped up by the press so much that even doctors are afraid to prescribe them even when they are legitimately indicated.

At these low dosages there is no feeling of elevated mood, (except for knowledge that you will be able to sleep), thus no desire to abuse the medication in order to feel "high".

If you get to the point where no other meds, including gabapentin, relieve your inability to sleep, don't be afraid to try low-dose opioids - they have saved my life.

[beartoothgirl406 in reply to Joolsg]

Thanks for the info! I have a new outlook on things now. I took 1/ dose last night with the LDN and was surprised my feet bothered me most of the night, but I didn't wake up depressed, If you say that after "detoxing" from Pramaprexole a person will return to the original level of condition. Mine was not bad at all pre-pramaprexole. Could I return to that state without any meds?

[Joolsg in reply to beartoothgirl406]

Most people return to their base line RLS, as it was before they started pramipexole or ropinirole, slightly increased to account for age. RLS does tend to worsen gradually as people age.

I do know three people personally who are med free after getting off dopamine agonists and having an iron infusion. Iron infusions dramatically improve RLS for 60%. 20% show no improvement.

You could very well return to the position you werein before pramipexole.

Ensure you get new full panel, morning, fasting blood tests. Don't take iron supplements for 48 hours beforehand. raising serum ferritin above 100, preferably 200 and even 300, can resolve the majority of RLS.

I recommended Dr Andy Berkowski. He runs clinics in Ohio and Florida. His website is very helpful.

relacshealth.com/

[SueJohnson]

It is expensive $7500 and requires a prescription. I don't know where you live and it would be helpful for you to indicate it on your profile They are not allowed to sell it outside the US and it is currently available only in California, Ohio and Massachusetts.

[beartoothgirl406 in reply to SueJohnson]

Hello, it seems that you are the "go to person" in the RLS world here. Would you mind re-posting your schedule for a beginner here on .25mg pramaprexole to begin the weaning off process? I am also on Low Dose Naltrexone which does help my RLS. I have a functional Medicine Doc that I will go over what you suggest and get a plan in motion. I see light at the end of the RLS tunnel! Many thanks Sue!

[SueJohnson in reply to beartoothgirl406]

Joolsg and others have pretty much covered it but I will repeat it. To come off pramipexole, reduce by half of a .125 tablet every 2 weeks or so. You will have increased symptoms. You may need to reduce more slowly or with a smaller amount. Wait until the increased symptoms from each reduction has settled before going to the next one. You will suffer and may need a low dose opioid temporarily to help out with the symptoms especially as you near the end. Some have used kratom or cannabis temporarily to help. But in the long run, you will be glad you came off it. If that is still too much to reduce, you can get an inexpensive jewelry scale that measures down to .01 gram from Amazon ($11 in the US) and shave off a bit of the tablet and measure it. Then reduce by that amount every 2 weeks.

Dopamine agonists like pramipexole are no longer the first line treatment for RLS. Gabapentin or pregabalin is. (Pregabalin is more expensive than gabapentin in the US.) The beginning dose is usually 300 mg gabapentin (75 mg pregabalin). Start it 3 weeks before you are off pramipexole although it won't be fully effective until you are off it for several weeks. After that increase it by 100 mg (25 mg pregabalin) every couple of days until you find the dose that works for you. Take it 1-2 hours before bedtime as the peak plasma level is 2 hours. If you need more than 600 mg take the extra 4 hours before bedtime as it is not as well absorbed above 600 mg. If you need more than 1200 mg, take the extra 6 hours before bedtime. (You don't need to split the doses with pregabalin) Most of the side effects of gabapentin or pregabalin will disappear after a few weeks and the few that don't will usually lessen. Those that remain are usually worth it for the elimination of the RLS symptoms. If you take magnesium even in a multivitamin, take it at least 3 hours before or after taking gabapentin (it is OK with pregabalin) as it will interfere with the absorption of gabapentin and if you take calcium don't take it within 2 hours for the same reason (not sure about pregabalin). According to the Mayo Clinic Updated Algorithm on RLS: "Most RLS patients require 1200 to 1800 mg of gabapentin (200 to 300 mg pregabalin)."

On the ferritin: Normal iron tests do not test for ferritin and normal results do not apply to those of us with RLS. . Ask your doctor if it and your TSAT were tested and if so, what they were. Improving your ferritin to 100 or more helps 60% of people with RLS and in some cases completely eliminates their symptoms. If not ask your doctor for a full iron panel. Stop taking any iron supplements 48 hours before the test, don't eat a heavy meat meal the night before and fast after midnight. Have your test in the morning before 9 am if possible. When you get the results, ask for your ferritin and transferrin saturation (TSAT) numbers. If your ferritin is less than 100 or your transferrin saturation is less than 20 ask for an iron infusion to quickly bring it up as this will help your withdrawal. If you can't get an infusion, let us know and we can advise you further.

Check out the Mayo Clinic Updated Algorithm on RLS which will tell you everything you want to know including about its treatment and refer your doctor to it if needed as many doctors do not know much about RLS or are not uptodate on it as yours obviously isn't or s/he would never have prescribed a dopamine agonist at Https://mayoclinicproceedings.org/a...

And as others have said if you need a low dose opioid don't be afraid of it.

[beartoothgirl406 in reply to SueJohnson]

I am blown away here. I just discovered this blog yesterday and I have so much hope! I printed your comment and will send to my functional medicine doctor and will make a plan. the jewelry scale is a great idea as that was going to be my next question. I am on .25 mg pramaprexole which I halved last night...with symptoms at night, of course. Is that too much for that dosage? But now I don't get depressed as I see the end result! I appreciate you!

[SueJohnson in reply to beartoothgirl406]

I'm not sure what you meant when you said is that too much for that dosage? If you meant did you reduce by too much, then yes. If you meant did your doctor prescribe too much, then no as the maximum dose for RLS is .50.

I'm glad you are no longer depressed but hang in there. It won't be fun and you will suffer but you can do it. And we will all be rooting for you.

[beartoothgirl406 in reply to SueJohnson]

Yes, sorry. I meant was I splitting my .25 in half too aggressive. thanks much!

[beartoothgirl406]

thanks, just added my location as Montana. Does it work?

[beartoothgirl406]

Another. thing I do is when the pramaprexole isn't working and my feet bother me in the early morning hours, I go down in dose for a week or so. I am normally on .25 mg dosage. I split the pill in half and am miserable for a week, then I go back to a whole pill. It seems to confuse the body and it works for awhile. The strange thing is when I am on photo shoots and am getting little or no sleep, augmentation never occurs. I will also get up in the middle of the night and play a brain game on my phone and it stops it in its tracks.

[Jumpey]

Great you're having relief at last.Keep is updated on the trial.

[Merny5]

I am scheduled to receive a device from Notrix Health. I received a call last week and was told that I will be the first in my state to get one so the are working with my insurance company. 🤞🏼I hope that goes well because I believe they are very expensive.

[beartoothgirl406 in reply to Merny5]

please keep me posted. I got on their list last month and I bet Montana will be low on the scale of importance. haha!

[SueJohnson in reply to Merny5]

That's great ! Do let us know how it goes. Which state are you in?

[beartoothgirl406 in reply to SueJohnson]

Montana

[Merny5]

my neurologist got involved and contacted the company as well. Evidently, the device has to be programmed like a CPAP machine. Therefore the medical supply companies need to get on board. Everything takes so much time when we are desperate for relief living one day at a time. Ugh! I will definitely keep you posted.