Clinical Trial for Fibromyalgia and ME/CFS Patients

Ecoclimber

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Big Antiviral Trial Could Usher in New Treatment Era for Fibromyalgia
By Cort Johnson

A New Approach to Fibromyalgia
Infections are a common trigger for fibromyalgia (FM), and fibromyalgia patients are experience many ‘sickness behavior’ symptoms, but we haven’t usually associated FM with viruses or immune system problems.

That’s been changing recently. A immune biomarker has been proposed. Small fiber neuropathy - possibly caused by immune dysregulation – has been found. Dr. Dantini has been treating FM with antivirals for years. The immune system’s starting to get some respect in FM.

Now, in a surprising twist, it’s going to be fibromyalgia rather than chronic fatigue syndrome, that’s getting the big, placebo controlled, double-blinded multi-center antiviral trial.

Eco
Perhaps another patient community may be the ones to validate ME/CFS
 
alex3619

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Half of all CFS patients appear to have fibro, they are commonly comorbid. I am unaware of data showing comordity rates for strictly defined ME.

I have been talking about this study today, though not here on PR. It shows promise, but is still no more than a pilot study. However at potentially 90% success its better than Rituximab at 67% success, and about what Lerner gets with antivirals iirc. Further the drugs are available as generics, which makes cost and insurance coverage easier to deal with.

I am unsure about long term use of antivirals or COX-2 inhibitors though. There are risks. On the other hand if I knew it might kill me but would most likely cure me I would take it anyway.

I have burning feet syndrome, and now I am developing burning body syndrome (not a real name, but like burning feet all over) and this is most commonly attributed to small fiber polyneuropathy.

@Ecoclimber, my version of your signature would be something like "When those who would be good do nothing, evil triumphs."
 
Sushi

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cph13

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@Sushi I just came from my IDisease Dr. She just gave me a script for the celebrex. She was very familiar with this study. I will call Dr. Pridgen. In the meantime, can U further explain what you mean? Thanks a whole lot. U R just ontop of everything. Thanks for the head up.

I am thrilled, my dr. had samples of metanx which is hugely expensive. Much better than keeping track of so many Solgar folate pills. Has anyone tried METANX.

Today, is a good day, a very, very good day. The snow in NYC made me real happy. I even enjoyed the sloppy, messy, traffic. Happy Healing....Hugs C
 
Sushi

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cph13 said:
@Sushi I just came from my IDisease Dr. She just gave me a script for the celebrex. She was very familiar with this study. I will call Dr. Pridgen. In the meantime, can U further explain what you mean? Thanks a whole lot. U R just ontop of everything. Thanks for the head up.

I am thrilled, my dr. had samples of metanx which is hugely expensive. Much better than keeping track of so many Solgar folate pills. Has anyone tried METANX.

Today, is a good day, a very, very good day. The snow in NYC made me real happy. I even enjoyed the sloppy, messy, traffic. Happy Healing....Hugs C
Click to expand...

Hi,
I think it is better to contact Dr. Pridgen directly. His email address is available,I believe, on the thread here about the study. Good to make sure you get the details right from the source if you want to try this. My post was meant just to do that--refer people to the source.

Best,
Sushi
 
cph13

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@Sushi Thank you for the heads up.
Itchy fingers and happy brain makes a dangerous pair.
I've sent an e-mail to my dr. so she can intercede and get this right. Thanks, and sorry if I jumped the gun here. I was just excited as I've always thought this condition is viral and inflammation and wondered why no-one ever used an NSAID. Back in 2003 my DH's oncologist had a study using an NSAID in high doses to starve the tumor. It was v. risky BUT at that point...well, he's in a better place.
I began mobic on my own last week for other reasons. We'll let the drs. handle this one. Happy Healing....Hugs C
 
nandixon

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It looks as though Pridgen has at least nine (9) concurrent patent applications pending (http://www.faqs.org/patents/inventor/william-l-pridgen-tuscaloosa-us-1/), which may all be essentially identical except for the specific combination of antiviral and COX-2 inhibitor used. In what may be the primary application here:

VALACICLOVIR AND DICLOFENAC COMBINATION THERAPY FOR FUNCTIONAL SOMATIC SYNDROMES
http://www.freepatentsonline.com/y2013/0203784.html

near the end of that particular application, there's some detailed study design info for all the combinations of drugs they may be looking at in the clinical trial:

Example B
Human Clinical Trial Protocol (PRID-201)

Title:
A Double-Blinded, Randomized, Placebo-Controlled, Proof of Concept Phase 2a Study Exploring the Safety and Efficacy of an Antiviral Drug (Famciclovir or Valaciclovir)+a COX-2 Inhibitor (Celecoxib, Meloxicam or Diclofenac) in the Treatment of Patients with Fibromyalgia.

Objective:
To explore the safety and efficacy of the combination of an antiviral drug (famciclovir or valaciclovir)+a COX-2 inhibitor (celecoxib, meloxicam or diclofenac) vs. placebo in the treatment of fibromyalgia (FM).

Study Design:
Randomized, double-blind, placebo-controlled, 16-week study to evaluate the safety and efficacy of an antiviral drug (famciclovir or valaciclovir) and a COX-2 inhibitor (celecoxib, meloxicam or diclofenac) combination for the treatment of FM patients. During the first week of treatment, a loading dose of the antiviral drug (famciclovir or valaciclovir) (2× maintenance dose) twice a day (BID) will be employed, followed by 15 weeks of maintenance dose of the antiviral drug (famciclovir or valaciclovir) BID. Depending on the patient population of the study group, use of a loading dose greater than 1000 mg/day is optional. The COX-2 inhibitor (celecoxib, meloxicam or diclofenac) dosage (also BID) will remain constant throughout the 16 weeks of active treatment.

Patients will be randomized to treatment with either combination therapy or placebo.

(Info regarding specific dosages is provided a little later in the patent application after the quote above. Additional info may also be available in the other 8 concurrent patent applications.)

Note: The study (PRID-201) appears to correspond to this clinical trial here:
http://clinicaltrials.gov/show/NCT01850420
 
Ecoclimber

Ecoclimber

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alex3619 said:
http://www.medicaldiscoverynews.com/shows/325-herpes.html

That is a link to comments on phase 1 of the study, phase 2 should have started early this year, though I am unsure about this.
Click to expand...

"Fibromyalgia's constellation of symptoms is very similar to those of chronic fatigue syndrome and Gulf War syndrome, which Oaklander's group also studies. "If someone has more of one symptom than another they might call it one thing, like chronic fatigue, but it's not clear that these are different," Oaklander says."

@Alex. We need to consider how this statement's impact is relevant to the IOM Panel ME/CFS Criteria process.

New research sheds light on mysterious fibromyalgia pain
Karen Weintraub, Special for USA TODAY 7:03 a.m. EST December 15, 2013

This new understanding of fibromyalgia will hopefully lead to better treatments, doctors and researchers say.

Fibromyalgia affects 1% to 5% of Americans, mainly women, but until recently, scientists had no idea what might be causing its severe and mysterious pains. For decades, doctors told patients their agony was imaginary, the result of emotional hysteria, not a physical ailment.

But this year, researchers finally began to get a handle on the condition.

"What's happened is in 2013 there's been this absolute explosion of papers," says neurologist Anne Louise Oaklander at Massachusetts General Hospital in Boston. "The whole view on this has shifted."

Oaklander published two studies this year showing that half or more of the cases of fibromyalgia are really a little-known condition affecting the nerves. People with this small-fiber neuropathy get faulty signals from tiny nerves all over the body, including internal organs, causing an odd constellation of symptoms from pain to sleep and digestive problems that overlap with symptoms of fibromyalgia.

Eco
 
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caledonia

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cph13 said:
@Sushi I just came from my IDisease Dr. She just gave me a script for the celebrex. She was very familiar with this study. I will call Dr. Pridgen. In the meantime, can U further explain what you mean? Thanks a whole lot. U R just ontop of everything. Thanks for the head up.

I am thrilled, my dr. had samples of metanx which is hugely expensive. Much better than keeping track of so many Solgar folate pills. Has anyone tried METANX.

Today, is a good day, a very, very good day. The snow in NYC made me real happy. I even enjoyed the sloppy, messy, traffic. Happy Healing....Hugs C
Click to expand...

Metanx contains the following active ingredients (per capsule):

  • L-methylfolate (Metafolin): 3 mg
  • Pyridoxal 5'-phosphate: 35 mg
  • Methylcobalamin: 2 mg
This is a huge amount of methylfolate, and it's more than the methylcobalamin, which will also be lessened to 1-2% of the given dose because it's oral.

So basically this supplement would likely cause methyl trapping and which stops methylation - the opposite of what you want.

I've only run into one person who requires large amounts of folate to get a good response.
 
R

readyforlife

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Is there anyone on this forum signed up for this study? And if you are, could you tell us what dose of Cellabrex and Valtrex you are on. Or if it's not Valtrex maybe its Famvir?
 
R

readyforlife

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Sushi said:
Unfortunely Cort got some of this wrong, including the name of one of the drugs! So don't jump in and try this yourself without contacting Dr. Pridgen.

Sushi
Click to expand...

Hey Sushi, Are you in this study?? Is the antiviral they us Famvir?
 
Sushi

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readyforlife said:
Hey Sushi, Are you in this study?? Is the antiviral they us Famvir?
Click to expand...

Hi ready,

I am not authorized to share Dr. Pridgen's protocol. I suggest that your doctor contact him directly. He is happy to correspond with other doctors. I am not in the study myself but know someone who is.

Sushi

P.S. I just heard that Dr. Pridgen is asking people to wait until the end of phase 3 of the trial (maybe mid- 2014?) to inquire further about this protocol. He is too involved in the trial to field a lot of inquiries at the moment.
 
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nandixon

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In the patent application I cited several posts above, for the Famvir/Celebrex combination, the dosing they indicated they might try for subgroups within the clinical trial (Phase 2a, I think) ranges as follows:

Famvir: 250-1000mg (500-2000mg loading dose 1st week only)
Celebrex: 200-800mg (held constant all 16 weeks)

I think the above amounts are total daily amounts which are given in two divided doses.

Dosing for combinations of other antivirals (e.g., Valtrex) and COX-2 inhibitors (e.g., Celebrex, diclofenac) are given in that same patent application and other ones of the additional eight (8) patent applications of Pridgen mentioned in my first post.

The purpose of the Phase 2 trial is not only to establish efficacy but also to try to optimize dosing for Phase 3 (if it happens), so it may be hard for Pridgen say what amounts are ideal at this point.
 
heapsreal

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Wow 800mg of celebrex is a big dose. 200mg is the normal dose for inflammatory conditions. Interesting.
Are they doing pre and post viral and immune testing etc.
Are they selecting pts with possible active herpes viruses or just those diagnosed with fibro. It would be good if they used pts with low nk function as well. Improves chances more for use as a biomarker.
 
cph13

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800mg dose is NUTS. That dose was used on my DH (as a cancer protocol in 2003). 800mg got him to dialysis. U can read about the old protocol (2003) here:
http://weill.cornell.edu/news/publications/pdf/thescope/2004-03-04.pdf go down to the article about Lung Cancer and Cox2 inhibiter....
and http://childrensnyp.org/mschony/news/hospital/65.html
(sorry I can't read these...still hurts. I chose to have DH use it.....:-{..... at stage 4 what is there???) I won't even take mobic...however, I did ask my dr. about the celebrex. I will LUK if I find out anything when she calls with my bloodwork results. I asked to be switched from famvir to valtrex. Don't know even if that's right. NO ONE KNOWS...Be well heaps...xo C
 
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