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FM drug trials

Seven FM drug trials are recruiting or are about to recruit patients.

What do a vaccine, a cough suppressant, a drug with only numbers for a name, an anesthetic, and the new migraine drugs have in common? They’re all either being tested in an FM clinical trial or are about to be.

FM may not be getting a lot of research but it’s definitely getting interest from some drug manufacturers. Check out the FM drug trials that are currently recruiting or about to recruit patients, and see if you’re interested in being in a trial. With some large, country-wide trials under way, many people in the U.S. will probably have access to one.

Drugs, of course, are only one treatment option. Many more trials using brain stimulation, physical manipulation and other options are under way.  A future blog is expected on those.

Tonix Gets Back in the Game

An updated form of Flexeril (cyclobenzaprine), Tonix’s TNX-102, looked like the second coming for awhile.  The new sublingual format of the drug shot it straight into the body, reducing the dose needed, and most importantly, bypassing Flexeril’s fatal flaw – the build up of a toxic element. It looked like people with FM were going to get treated to a drug which reduced both sleep AND pain.

But then the phase III trial failed to meet its primary endpoint, sending the small drug company’s stock price plunging and wiping out millions in value. In truth, the drug hadn’t done all that badly. It significantly helped with sleep and overall symptom burden – but didn’t, unfortunately, meet its primary endpoint on pain. Its interest in FM apparently over, Tonix reported it would focus on PTSD.

But then Tonix took a second look, re-analysed their data, had a successful PTSD trial, and suddenly was back in the game. The proposed fix was startlingly simple: simply double the drug dose to that which was successfully used in the PTSD trial.

Apparently, they were able to convince their investors to give them one more shot, because three weeks ago, Tonix officially opened a major 39-site 14-week U.S. fibromyalgia trial. If you live near a big metropolitan center, there’s a good chance a trial is going on in your area. This phase III trial is the best shot FM patients have at a new FDA-approved drug in the near future.

People from 18-65 years of age with a diagnosis of FM, and a certain level of pain, can participate in the trial. Contact Mary Aloisio, 619-395-5767, mary.aloisio@tonixpharma.com, if you’re interested.

Getting Vaccinated Against Fibromyalgia Pain?

“Given what’s been published in the medical literature, we believe this vaccine will reverse the immune system abnormalities [of fibromyalgia].” Dr. Bruce Gillis, Epigenetics CEO

A vaccine to stop pain sounds like a pretty far-out idea but the Swedish doctor Carl Gottfries reported that he successfully used a staphyloccus vaccine in chronic fatigue syndrome (ME/CFS) for over 50 years.  The BCG vaccine has been around even longer. Still the only vaccine used to fight tuberculosis, the BCG vaccine has been used for over 100 years. (It’s not used in the U.S. because of the low risk of tuberculosis.)

BCG vaccine fibromyalgia

Could a vaccine tamp down the pain in FM? (Image by Arek Socha from Pixabay)

I was unable to find any studies published on the Bacillus Calmette-Guérin (BCG) vaccine in FM but the vaccine itself has gotten plenty of study.  A 2017 review reported that the vaccine had shown good results in mice asthma, multiple sclerosis and insulin-dependent diabetes studies.

The Los Angeles-based biomedical firm EpicGenetics came upon the vaccine idea after discovering what they believe is the first blood test for FM – the FM/a test – which measures the levels of four chemokines and cytokines that two studies indicated were reduced in FM. (The FM/a blood test will be featured in a future blog).

Vaccines are primarily used to fight off pathogens but they also stimulate the immune system. The BCG vaccine just happens to stimulate the four chemokines and cytokines found reduced in FM – hence the trial.

The 300-person, randomized, triple-blinded, Phase II, Mass. General Hospital BCG vaccine trial started in January of this year and is expected to end up in January 2022. A call went out earlier this year for more men and younger female patients.

This is a phase II safety and efficacy trial. If the trial is successful, larger phase III trials will be needed to get FDA approval.

Contact Denise L Faustman, MD, PhD 617-726-4084 fibromyalgiastudy@partners.org if you’re interested

NYX-2925: The Central Sensitization Desensitizer? (say that three times in row:))

Aptinyx is a small drug company which, like Tonix, had troubles of its own. The company went public behind its $118 million IPO,  then promptly saw its stock price get whacked when its featured product failed to meet its primary endpoint in diabetic neuropathy.

Aptinyx was whistling Dixie with the results of its FM trial, though. Both brain scans and clinical scores improved in the two-week trial of the NMDA modulator.

Will NYX-2925 be able to calm the flames in FM patients’ brains?

By significantly reducing levels of the excitatory neurotransmitter glutamate (glutamate/glutamine (Glx)) in the anterior cingulate and insula in the brain, this unique drug seemed to strike at the very heart of the central sensitization process occurring in FM. The drug also reduced the up-regulated pathways found between brain regions implicated in pain processing in FM.

Longtime FM advocate and researcher Daniel Clauw called the results “compelling” and stated that the drug appeared to be “addressing the type of centralized pain evident in patients with fibromyalgia.”

The company certainly thinks they’re onto something. Their 15-week, 300 person, randomized, double-blinded, placebo-controlled Phase II drug trial was due to begin this November and is slated to last until Feb. 2021. It will be assessing pain intensity, sleep, pain reduction, overall symptom reduction and cognition.

People with FM between the ages of 18 and 65, with a certain level of pain, and who meet other criteria are eligible to take part in the trial. Contact Sarah Torri at 847-871-0377 or clinicalstudies@aptinyx.com, if interested. The trial is taking place at 25 sites across the U.S.

The New Migraine Drugs Take Aim at Fibromyalgia

The new monoclonal antibody antibody drugs designed to put a hurt on calcitonin gene-related peptides (CGRP) are revolutionizing migraine treatment. With two anti-CGRP studies under way in fibromyalgia, we’ll see if they can do the same for FM.

The Migraine Drug Explosion Begins: Could Fibromyalgia and ME/CFS Benefit?

There’s certainly reason to believe they may be able to. Migraine may be the most common disease associated with FM, and CGRP, a potent vasodilator, enhances the transmission of pain signals. These anti-CGRP drugs are used in migraine to reduce the activation of the trigeminal nerve in the head, neck, sinuses and jaw but CGRP is believed to regulate pain levels throughout the body.

Given the strong overlap between migraine and fibromyalgia, it’s no surprise that a couple of anti-CGRP drug makers have their sights set on FM. Check out one person with severe migraines and fibromyalgia describe how an anti-CGRP drug helped with both conditions.

New Anti-CGRP Migraine Drugs Disappear Both Migraine AND Fibromyalgia For Liz

The Teva Trial

Teva, the drug manufacturer, is going long in its Phase II FM fremanezumab trial. The 35-week, 240 person, randomized, double-blinded, placebo-controlled trial is taking place in 30 sites across the U.S.

Starting in May 2019, it’s expected to last until August 2021. Pain, quality of life, sleep, fatigue, overall health, physical functioning, and mood will be assessed.

Contact Teva U.S. Medical Information at 1-888-483-8279 or email them at USMedInfo@tevapharm.com, if you’re interested.

The Fibromyalgia and Small Fiber Neuropathy Trial

If you happen to have small fiber neuropathy and FM, you may be able to participate in the “Anti-CGRP for Inflammation and Pain Modulation in Small Fiber Neuropathy/Fibromyalgia” trial featuring Galcanezumab.

The trial is starting in December and ending June 2021. To find out about this 20-person North Carolina trial contact: Kelsey Ling, 919-684-2713, kelsey.ling@duke.edu

Suppressing Neuroinflammation (with a cough suppressant)

Jarred Younger is leaving no stone unturned in his efforts to knock down the neuroinflammation his work suggests is doing people with FM and ME/CFS in.  Better known as a cough suppressant, dextromethorphan is an NMDA receptor agonist with quite a track record as a neuroprotector. It’s been shown to protect neurons from glutamate excitotoxicity, hypoxia and ischemia (all of which may be occurring in FM) and it inhibits microglial activation to boot.

Younger’s small, 15-person non-randomized  dextromethorphan trial at the University of Alabama at Birmingham began in June of 2018, and is expected to end in June 2020.

The Canadian Ketamine Trial

Finally, if you’re in Toronto you might want to check an IV Lidocaine and Ketamine trial for neuropathic pain. Ketamine, an anesthetic with both pain and depression-reducing properties, is one of the most interesting compounds going.  I know of one person with ME/CFS who was able to reduce his opioid drug intake markedly once he got on ketamine.

The 70-person “Ambulatory Infusions of Lidocaine and Ketamine for Management of Chronic Pain” trial is starting at the end of this year and ending at the end of next year.

Contact: Ramin Safakish, MD. FRCPC, 647-478-8462, Ramin.Safakish@AllevioClinic.com or Shadi Babazadeh, MD, 647-478-8462 ext. 90, shadi.Babazadeh@AllevioClinic.com

The NIH HEAL Initiative Begins

The NIH’s 945 million dollar Heal Initiative to combat the opioid epidemic and develop better pain drugs finally got underway with hundreds of awards given out last September. From brain stimulation to ion channel inhibitors to epigenetic modifications, many different treatment approaches are being assessed. Only one FM trial (assessing TENS units) is included but the initiative will hopefully tell us much about how chronic pain occurs and how to combat it. The NIH reportedly hopes 15 new ways to combat pain will come out of the initiative.

  • Treatment Takeaway – Seven drugs are currently or are about to begin treatment trials in fibromyalgia. One drug trial currently recruiting patients is a phase III trial; i.e. it’s in last stages of FDA approval. The rest are in Phase II or in earlier phase trials. Other drugs and treatment trials are underway as well. With brain stimulation, physical manipulation, nutrition and other trials underway a variety of options are being explored. 

Health Rising’s End of the Year Fundraising Drive Update

Thanks to the 97 people who have contributed almost $6,800 dollars to keep Health Rising going next year. We are about 15% of the way to meeting our goal.

HR strives to be comprehensive. That’s why when we decided to check out FM drug trials getting underway we didn’t do a blog on a drug trial in FM – we included all of them. Plus, we provided information on where they are, when they started, how long they last, and how to get in touch with them. If that’s the kind of comprehensive information you want, please consider supporting Health Rising. We are almost entirely donation driven.

 

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