Nothing for Progressive

[Russ4210]

When first diagnosed in December 2001, I, like most, was Dx with R&R MS. I began DMD with Beta-B and stayed on it for about 3 years. Then, I read the FDA trial data on Beta and the other DMDs. I wasn’t impressed.

I stop the DMD treatment, because I realized that I was not R&R. Yeah, I had flare ups and my foot drop eventually lessened. But my flare ups were self-induced. I wasn’t taking care of my self, not eating right, sleeping right, working too hard, too long, a ton of stress (self employed will do that) and generally ignoring all the things I should have been doing to manage my MS.

As time went on, it became clear to me that my MS was of the Progressive form. I didn’t have exacerbations. I have some flare ups for sure, but my symptoms generally stayed the same and very slowly progressed.

I am now on SS Disability. My job (business) was very physical and I can no longer work safely. I was taking huge risks with my work. My cognitive abilities really have gotten worse. Heat sensitivity and fatigue (always present) were the last straw. My Ataxia has progressed where I use a Cain sometimes.

My Neurologist always wants me on a DMD. We talked about what I say is unimpressive trial data. He now characterizes my MS as Progressive. All the DMD are for R&R. Nothing for Progressive, or Secondary Progressive are FDA approved. Yet my Neuro wants me on something.

I don’t like spending money and not have improvements. Even if it’s the Insurance Company’s money, I just don’t like blindly spending money.

Now, if the DMDs are working for you, then Hallelujah! I’m happy for you.

I’ve resigned to the notion that there isn’t any therapy for Progressive MS. Some days are better than others, and each year comes with a little less of everything. Sometimes I wish my MS would just get along and do whatever it’s going to do. It least I’d know.

[GandalfRA]

I hope there is a connection with other auto inmune diseases so when they cure another one there will be a link to cure ours.

Good luck.

[JerryD]

Russ,
I was also self-employed before I was dx'd in 2009. I was told to 'get on one of the dmd's right away'. I asked the neurologist, after I did some research, why the paperwork for the meds did not include patients with PPMS. The answer was not good enough to get me on the drugs.
So, do the things you have been doing. Do everything you can to keep yourself healthy. Good luck

[Jules A]

I hate that there isn't anything for progressive forms of MS.

[Nash]

Hi Russ,

I'm from france so maybe my langage will be not really good but i really want to share you something.

> I can't tell you it will treat your MS but about 90% of the people who try that had a good result. It's a diet called seignelet's diet, gluten-free and much more, it's a hard diet and the result are not comming at once (about 1 or 2 years).I put a discussion about that in the ms forum about the food.

> What about BG-12 for progressive MS ? It's work with R&R but maybe it will work for progressive forms as well ? we don't know yet.

Anyway, I really hope better day for all people with MS

[knuckle]

A pilot trial of low-dose naltrexone in primary progressive multiple sclerosis.

http://www.ncbi.nlm.nih.gov/pubmed/18728058

Abstract

A sixth month phase II multicenter-pilot trial with a low dose of the opiate antagonist Naltrexone (LDN) has been carried out in 40 patients with primary progressive multiple sclerosis (PPMS). The primary end points were safety and tolerability. Secondary outcomes were efficacy on spasticity, pain, fatigue, depression, and quality of life. Clinical and biochemical evaluations were serially performed. Protein concentration of beta-endorphins (BE) and mRNA levels and allelic variants of the mu-opiod receptor gene (OPRM1) were analyzed. Five dropouts and two major adverse events occurred. The remaining adverse events did not interfere with daily living. Neurological disability progressed in only one patient. A significant reduction of spasticity was measured at the end of the trial. BE concentration increased during the trial, but no association was found between OPRM1 variants and improvement of spasticity. Our data clearly indicate that LDN is safe and well tolerated in patients with PPMS.

[Nash]

A pilot trial of low-dose naltrexone in primary progressive multiple sclerosis.

http://www.ncbi.nlm.nih.gov/pubmed/18728058

Abstract

A sixth month phase II multicenter-pilot trial with a low dose of the opiate antagonist Naltrexone (LDN) has been carried out in 40 patients with primary progressive multiple sclerosis (PPMS). The primary end points were safety and tolerability. Secondary outcomes were efficacy on spasticity, pain, fatigue, depression, and quality of life. Clinical and biochemical evaluations were serially performed. Protein concentration of beta-endorphins (BE) and mRNA levels and allelic variants of the mu-opiod receptor gene (OPRM1) were analyzed. Five dropouts and two major adverse events occurred. The remaining adverse events did not interfere with daily living. Neurological disability progressed in only one patient. A significant reduction of spasticity was measured at the end of the trial. BE concentration increased during the trial, but no association was found between OPRM1 variants and improvement of spasticity. Our data clearly indicate that LDN is safe and well tolerated in patients with PPMS.

What a good news, thanks for sharing that

[Russ4210]

Human Ginny Pigs

When I was reading the various FDA trial data on DMDs for MS, one phrase kept appearing, “Statically Significant results”. My apologies to Statisticians, but Statically Significant is a way to put lipstick on a pig.

Most drugs are for R&R and a major DMD end point is the reduction in exacerbations. Generally speaking, most R&R patients have 2 or 3 exacerbations a year. So when the trial data show a reduction of 30% in exacerbations, that means you have 1 less a year. Now if your exacerbation is blindness or paralysis, then that’s darn well worth it.

Another end point examined is the lessening of lesions. Many trials show a reduction of lesions seen on MRIs. Unfortunately, there is no concrete, absolute evidence or correlation of reduction of lesions and reduction in physical disability. Sure makes sense, though.

Then there is always the following: if you’re on a DMD and get better, it cannot be said the DMD therapy is working. If you’re on a DMD and don’t get better, it cannot be said the DMD therapy did not work. The issue is none of the DMD manufacturers (MS Researchers) have any idea how their DMD work. They only have trial data that show Statically Significant results.

The majority of DMD trial data I’ve read show a reduction of 30% – 45% in “name your exacerbation”. None of the trials have a clued how / why the DMD works, just that is has Statically Significant end points.

Do you ever feel like we’re human Ginny pigs?

Then there are the side effects. It took me about 6 months to tolerate Beta-B. It seems just about every drug has side effects like head aches, flu-like symptoms, sleep disorders, 24hr diarrhea, and oh yeah, death.

They have to start somewhere. It’s a start. For 40 years (since Beta –B), it’s been a start.

Thanks for tolerating my rant. I just had to get this off my chest.

[Russ4210]

Where to buy drugs

I’m on two drugs for my CID (Constant Incontinence Disorder). The cost for one isn’t all that costly, but the other is a major financial hit. I take desmopressin (generic for DDVAP) and it’s expensive, like $1,200 every 3 months. Not as costly as the DMD I was on, Beta-B at $1,500 per month. I read Gilenya is $4,000 per month.

I finally went with a local Canadian Rx broker. They have an excellent reputation and work only with reputable Canadian pharmacies. Through them, my drugs are 40% - 60% less. The cost no longer goes against my yearly deductible, but the difference in cost is too great to ignore. If I’m having a difficult year, I’ll meet my deductible anyway.

I have to carefully plan refills, because it takes 2 – 4 weeks to have them refilled and arrive. I don’t know if any of the DMDs are available through Canada.

Keep this in mind and do some math. It might make financial sense for you too.

[JerryD]

Russ,
You keep going on your rants. I learn a lot from your experience. I have been dx'd PPMS. And I am on my own to find any treatments. The thing 'knuckle' always writes is about LDN and endorphin production. I will never buckle under to the thought that I need to be on a DMD. There will be a 'cure', someday. 'When the Saints come Marchin' in'.

[BigA]

Russ,

I'm RR or PR or something - too soon to tell, so I can't speak for your experience. However, I get that you're intelligent and sceptical.

But when there's no "scientific" cure, you might explore safe, cheap complimentary treatments such as diet, exercise and meditation. There is scientific evidence (not proof) on some of them and you have nothing to lose.

If you want to rant about the sorry state of MS drugs, even for RR, despite all the excitement, then you have my agreement - but still, you might explore.

[Kippy]

NIH Trial for PPMS

Hi.
Just returned from my second visit to the NIH in Bethesda, MD and was told by the head researcher that I am 99% accepted into the trial for Idebenone for PPMS.

The trial has been going on for awhile now, and they've been seeing some differences between the group taking the high doses of Idebenone and those taking the placebo.

The doctor told me that the different thing about the Idebenone from the CoQ10 is that the latter does not go through the blood/brain barrier tissue while the manmade Idebenone (at high doses that they give) does go through the barrier and therefore hopefully affects the cells in the CNS. The purpose of the trial is to see if that theory works.

I won't get on the med or the placebo until next July, since they'll be evaluating me for a year to follow my progression. After that, it's two years of either the Idebenone or the placebo, but if something seems to be helping slow progression, they'll assume it's the Idebenone and give it to everyone in the trial.

At least I think that's what it's about!

[ijustcallit]

I am secondary progressive. I was at my doctor this past week. He is a well known researcher at a large teaching university.

Basically, there are no new meds on the horizon for any progressive forms.

Most research and clinical trials are for RR. It is easier to study. Less dropouts. Always new people coming in.

It really sucks for us progressive types. We are probably too late, even for the stem cell treatments.