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Breaking News-Clinical Study on Cluster Headaches

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Hello Everyone,

As some of you may know from our conference last year, Clusterbusters has been in close dialogue with Eli Lilly and Company regarding the following release. Among our priorities, has been to provide them with what we felt was important input from the patient community. We are very pleased to be involved in this and will be providing additional information to our membership as it becomes available.

Eli Lilly and Company has informed Clusterbusters that the company plans to start a research program for episodic and chronic cluster headache. Lilly is excited to start this program and work with Clusterbusters to actively help enroll patients. The company will provide more information, including the locations of participating study sites, to Clusterbusters and on the web at www.clinicaltrials.gov (expected in late March). Lilly expects the program to begin actively enrolling in late April.  At this time, please do not make any changes to your current medical treatment or otherwise to try to qualify for this study.

HereÂ’s some additional information about Lilly from the companyÂ’s website: Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels

Bob

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Latest update. You are hearing it here first.

Subject: More details available on Eli Lilly clinical study

Clusterbusters has been informed by Eli Lilly and Company that additional details regarding their clinical study in patients with episodic cluster headache have now been posted on clinicaltrials.gov. (see below for website).  Please note that investigator sites (doctorÂ’s offices conducting the study) will continue to be added to clinicaltrials.gov as they become approved by ethics committees over the next few months.  You will receive another communication from Clusterbusters (late April), when enrollment for this clinical study begins.  At that time, if you are interested in participating in the study, you will have the option to complete a questionnaire to help determine whether you may qualify for the study.

Additional details on the chronic cluster headache study will be available on clinicaltrials.gov in April.   You will receive another communication from Clusterbusters in June when enrollment for this clinical study begins.  At that time, if you are interested in participating in the study, you will have the option to complete a questionnaire to help determine whether you may qualify for the study.

Please visit the following site for more details:

https://clinicaltrials.gov/ct2/show/NCT02397473?term=LY2951742&rank=3

ClinicalTrials.gov Identifier:

NCT02397473

A Study of LY2951742 in Participants With Episodic Cluster Headache

Bob Wold

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is this study based on busting or a complete new drug

Complete new drug, which has shown great effectiveness for preventing migraines.  A lot of people in the know think this could be a very big breakthrough for CH.  Read more about the drug (LY2951742) here: http://www.arteaus.com/role-of-cgrp-in-migraine.html

Gotta say again that my heart goes out in huge gratitude to those who will participate in this, who will risk (as I'm reading it) 8 weeks in cycle taking an ineffective placebo.  I am assuming/guessing that they'll still be allowed to use oxygen to abort attacks, but I'm also assuming/guessing that any pharma meds (verap, trex) might be prohibited.  Just guessing about all that.  Obviously, we'll learn more as it's underway.

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  Congratulations and well done Bob mate,

Here is an interesting talk by PG,

He talks first about CH and then goes on to chart the progression of this field of research (migraine) from cats (1985) to Lilly's acquisition/reacquisition of Arteaus

"Bedside to Bench and Back: Improving care for headache disorders"

 

He could do with some advice on his wardrobe.

Previously April 22, 2014 -

CGRP-targeted migraine prevention drugs succeed in phase II

clinicalneurologynews

http://www.clinicalneurologynews.com/index.php?id=9985&type=98&tx_ttnews[tt_news]=249161&cHash=da03e20e36

Drugs that hit CGRP may even help other headache types, Dr. Dodick added.

"There is some evidence that CGRP is also important in other serious headache disorders such as chronic migraine, medication overuse headache, and cluster headache – disorders that are currently very difficult to manage."

shocked

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Gotta say again that my heart goes out in huge gratitude to those who will participate in this, who will risk (as I'm reading it) 8 weeks in cycle taking an ineffective placebo.  I am assuming/guessing that they'll still be allowed to use oxygen to abort attacks, but I'm also assuming/guessing that any pharma meds (verap, trex) might be prohibited.  Just guessing about all that.  Obviously, we'll learn more as it's underway. 

CHfather, I agree... although the previous RCT was conducted on migraineurs... (another hand-me-down intervention)... the efficacy of this monoclonal anti-body was only slightly better than the placebo...

"The mean change from baseline to week 12 in the number of migraine headache days was -4·2 (SD 3·1; 62·5% decrease) in the LY2951742 group compared with -3·0 (SD 3·0; 42·3% decrease) in the placebo group."

See the following link for details: 

http://www.ncbi.nlm.nih.gov/pubmed/25127173

I attended the 2014 American Academy of Neurology Annual Meeting last April in Philadelphia, PA to make a poster presentation on the survey results of 127 CH'ers taking the anti-inflammatory regimen with 10,000 IU/day vitamin D3 to prevent their CH...  See the following link for the abstract.

http://www.neurology.org/content/82/10_Supplement/P1.256

While there at AAN, I had the opportunity to sit in on a pair of RCT's being briefed on the use of monoclonal antibodies with an appetite for CGRP being used as a preventative for migraines by Dr. Peter Goadsby MD and Dr. David Dodick MD who tag-teamed as Principal Investigators on these two studies... 

In short, with a lot of hand waving (and pay no attention to what's behind the curtain) the list of adverse events appeared more significant than the claims of efficacy in these two studies.  I commented over at CH.com last year that it was only a matter of time before they would announce a study using one or both of these same preventatives for CH...

Monoclonal antibodies (MABs) are classified as biologics.  Like prednisone, they cut both ways.  While MABs won't cure a disorder, they can lessen the symptoms and in some cases, halt the progress... but at a price...

Unfortunately, all biologics/MABs (the name of the biologic ends in "mab") carry a long list of side effects that range in order from nasty to down-right onerous including: compromised immune system, life threatening infections like tuberculosis and pneumonia, fungal infections and a growing list of cancers.  Watch the TV ads for Humira (Adalimumab) and you'll get an even longer list of side effects.

I can give you first hand testimony as to MAB side effects...  I was a participant in a study at the National Eye Institute, NIH, where I was given daclizumab.  It is typically given to organ transplant patients to prevent organ rejection.  I took it to treat an autoimmune inflammatory eye disorder...  basically to prevent my retina from rejecting me...

Over the course of the year long treatment with daclizumab, it knocked my immune system to parade rest, I developed squamous cell carcinoma and finally eosinophilic meningitis.  These were among the known side effects of daclizumab listed in the consent form I signed prior to starting this study.  The only reason I participated in this study was at the time, not knowing any better... these side effects appeared to be the lesser of the evils compared to going blind.  I didn't... but for another reason... and it wasn't due to daclizumab...

According to Consumer Reports, MABs are very expensive, with some costing more than $5,000 per week..." 

As a side note, the mechanism of action in the capacity of vitamin D3 and the rest of the cofactors in the anti-inflammatory regimen to prevent CH is thought to be the down-regulation/suppression of CGRP.  With a raw efficacy of 83% of the CH'ers taking this regimen experiencing a significantly reduction the frequency, severity and duration of CH and 60% experiencing a lasting pain free response...  all with no adverse side effects, lots of health benefits and a cost of 35 to 45 cents a day...  I think you can see where I'm going and why I would choose vitamin D3 and the cofactors over a genetically cloned biologic.

I know how important it is to all CH'ers to have studies like this conducted so please don't think I'm throwing cold water on the upcoming study of LY2951742 as a CH preventative...  I hope this study finds it is very effective in preventing CH... 

That said, risk of adverse side effects from MABs are real, and I would caution anyone planning to participate in this study to read the consent form very carefully, then do your own risk/reward assessment before proceeding.  There are alternatives.

As an added side note...

HumiraCost_zpshculkhzc.jpg

http://www.drugs.com/price-guide/humira

The cost of an FDA approved form of LY2951742 will likely fall in the above range...  and I fear it will not be covered under Obamacare...

"In 2001, Abbott Laboratories spent nearly $7 billion on the biggest acquisition in the company's 123-year history, primarily to access one drug, Humira.

Since then, the North Chicago-based drug giant has raked in more than $24 billion in sales from Humira, a pricey medicine derived from human cells and used to treat a variety of autoimmune diseases. This year, Humira is forecast to have its biggest year ever, with some analysts projecting more than $7 billion in sales."

http://articles.chicagotribune.com/2011-05-24/business/ct-biz-0525-humira-biogenerics-20110524_1_way-for-genetic-engineering-biotech-drugs-abbott-s-humira

Take care,

V/R, Batch

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Well Batch, two shots would wipe out your part D Medicare and put you in the hole!!!!!

Reminds me of all the new Hep C adds. They want you to call, there is help for your Hep C. Yes, and the cheapest course of this new treatment (there are actually two) is $84,000.00. My understanding is that you can get the treatment in the East - Egypt or one of those nations, for $12,000.00 Talk about a rip off.  >:(

I really hope something works, but from your statement, I doubt that this will be it.

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Batch,

Thanks for your comments. Let me say a few things.

First of all, let me tell you that I feel your frustration regarding getting people to listen about D3.

You've had it easy though. You've tried to get people to listen about a vitamin. Try getting the same doors slammed on you while trying to explain that a schedule one drug (psilocybin, LSD) is safer and more efficacious than anything on the market. ;-)

I can assure you and I'm sure you understand from my own stance and that of Clusterbusters, that we have always had the same skepticism and issues with Big Pharma.

I've taken a beating over the years for pointing out the costs involved and the side effects of cluster medications. Every time I quote the deaths involved in the early Imitrex days and since, I get hate mail. Not from Big Pharma but from people that use them safely and a couple of groups that think that only pharmaceutical options should be discussed and suggested for use.

That said, I hope that people understand that we wouldn't be involved in this study if we didn't think it was an important step forward for people with clusters.

As to the possible future costs, we have no idea if it will get approved but if it does, have no idea what the cost will be. Costs are usually based up the other options people have and other condition specific issues.

I had a prescription for Migranal filled this year. 8 bottles that are supposed to be a month supply. The cost? $3500.00 and that was for the GENERIC. A generic for DHE which has been around for decades. (DHE, not the generic)

As to the research, no one has ever made this sort of investment in a phase three cluster study.

They are doing this without it being approved as an orphan drug which would have allowed them to charge prices we see for other orphan drugs, like $38,000.00 a year.

There are other companies doing more research on this class of drugs in migraine. If it is successful and safe enough to be approved, those medications would end up being like every other migraine drug that is handed down to cluster people. Off Label with all the inherent problems that come with that such as insurance coverage refusals.

This study will show efficacy in clusters and not having doctors prescribing them off label and guessing at efficacy and safety in cluster patients.

One of the most important parts of this study is that scientists are actually learning about and researching the mechanisms behind cluster headaches.

Much of the research in clusters before this was directed toward invasive surgery. I much prefer looking at this route to expanding deep brain stimulation.

There is a lot more I could say about this study and will as it progresses. But I do believe Lilly is going about this in the right way. Working with the cluster community and learning about the condition. They could have directed this study toward migraine and then thrown it at us with little or no understanding of the cluster headache mechanisms.

Hopefully work that will one day lead to a cure. This isn't it, but it's a step that no one has been willing to take up until now.

In the meantime, Clusterbusters is continuing our work with psilocybin and that study should also be taking place this year.

We are also about to announce the start up of our genetic study.

Bob

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"doors slammed"

issues with Big Pharma.

we've come a long way

work that will one day lead to a cure.

work with psilocybin and that study should also be taking place this year

our genetic study. 

Well done Bob mate, well done team.

Savouring these great day's

Celebratory accoutrements, comestibles and suitably potent potables standing by.

shocked

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"monoclonal antibodies and the calcitonin receptor system are showing promise"

WhatÂ’s on the horizon for headaches

By: HEIDI SPLETE, Ob.Gyn. News Digital Network

http://www.obgynnews.com/home/article/video-whats-on-the-horizon-for-headaches/6161043b663f24f639bec4d8b2070b49.html

"Dr. Goadsby explained details of several studies that showed dramatic results, and the “tantalizing” implications for patients."

shocked

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Update:

First off, this is the latest release. Posting it here so it's a record in this thread and in case people didn't catch it in the others.

Subject: Eli Lilly NOW Enrolling Episodic Cluster Headache study

Eli Lilly has recently informed Clusterbusters that they are now enrolling patients with Episodic Cluster Headache into their clinical study. Many of you likely reviewed the details on clinicaltrials.gov.  For more information and to pre-screen for this study, please click on the link below or dial the toll free number.

If you pre-qualify for the episodic cluster headache study based on the initial questionnaire, your information will be provided to a physician and you will be contacted for further evaluation.

This study is enrolling now. Get started here.

For more information, visit www.ClusterTrials.com or call us toll-free at 1-855-375-7139.

Secondly, I wanted to answer a few questions and make a couple of comments.

We enrolled our first patient already and he will begin participating next week. I can say we because it's a Clusterbuster Clusterhead.

The Chronic study is set to begin recruiting patients in the beginning of June. Clusterbusters will let everyone know when it goes live on clinicaltrials dot gov

If you have been pre-approved already but were told that there was not a study location near you, that may change and you will be contacted. If you check the listing of site locations listed on clinicaltrials dot gov and scroll far right, you can check to see if the closest site near to you has started actively receiving patients. Some sites have not yet come online but will very shortly. You may have one close by and been told there wasn't a site for you. They are also opening up the travel radius for us.

If you're not yet 18 years of age, but will be within the year, wait until you turn 18 and go through the pre-approval process to see if there are still any spots open.

If you are interested but have questions about your previous use of psychedelics, you're best bet is to go through the approval process and if pre-approved, you'll be able to get all your answers from the Clinical study site doctors/investigators. Don't fret, they are working with Clusterbusters afterall, so.....

Botox will not necessarily exclude you. I would suggest going thru the process and if approved, you can speak with the doctors.

If approved and end up getting a placebo, you will not be left to suffer without meds. Your doctor will explain the process and what all is allowed.

Best not to assume anything.

Eli Lilly spent a great deal of time with cluster patients as well as accepting recommendations from clusterbusters. They are actively dealing with us constantly and were doing so from the beginning of the study design to make sure that there was a balance between what was best for the study and what was best for the patients.

As to treating symptoms and not the cause, this is true in many ways. However, One of the ways to finding a cure is to determine what symptoms are being caused by the condition, where they originate from, and what treatment eliminates those symptoms. This is the only way to work backwards to the root problem. So far we don't have many clues as to what really works consistently to treat the symptoms. This is one reason why research into psychedelics is still important. it helps build the roadmap towards a cure.

If it turns out that CGRPs are an effective and safe treatment, then they need to be tracked back to whatever is sending these molecules on their way to causing such pain.

Therefore, I feel this is a huge step forward to finding a cure if successful. The fact alone, that this is the first time ever that clusters have been studied to this extent, means it's probably the biggest step toward a cure we have had in 350 years.

We will be taking another big step forward this year when we open up our genetic study. Once we identify the gene(s) involved, we will actually have some dots to connect.

Bob

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Hi,

 

I have been approved to participate in this study, but am having some serious reservations about doing so. I'm not sure what I am hoping to gain from posting here, but a sounding board would be most appreciated.

 

I think my biggest reservation is being unable to use LSA or MM to abort the cycle that is about to start any day now. Being a licensed health care professional, I am not exactly at liberty to disclose that to the MD, but I would like to know if it is an absolute exclusion criteria. I am allowed to use O2 and Zomig to abort, and had little luck with either RC seeds or MM in the winter cycle, so maybe I am making more out of htis than need be.

 

I have never been in a clinical study before and am a bit nervous about having an unknown substance injected into me. If there are side effects, I'm stuck with them until the drug wears off.

 

Any advice, suggestions, or thoughts?

 

Thanks

 

 

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