A Surprising New CGRP Study

The past few weeks have been very eventful for me. One of the most significant developments was receiving a call from H, who coordinated my two CGRP-antagonist preventative open label studies for Amgen and Teva. I knew that she was keeping an eye out for another clinical trial I could participate in that would not be too restrictive and would also guarantee my receipt of actual medication and not a placebo.

No one to help navigate insurance denials

There is some buzz in the migraine community about erenumab possibly being released far sooner than we'd expected. Due to circumstances which I'll explain later, I currently do not have a neurologist to prescribe it or to help me navigate the inevitable insurance denials and appeals. In fact at one of my last appointments, he stated that he assumed I would be getting erenumab from the clinic where I participated in the study, never mind the fact that I was never an actual patient there. My new neurologist, who is actually my old neurologist (I saw her over twenty years ago when she was a resident at a nearby teaching hospital, and she was wonderful), now practices in Chicago. My appointment with her is not until July.

With my sumatriptan prescription still on hold, I was feeling increasingly desperate and nervous, particularly with my ER also having changed their opioid policy for 2018. H's call came at exactly the right moment.

A new abortive option

What she told me was a huge shock to me, because despite thinking that I had kept up with the latest research I had not been aware that at least one drug company had reformulated the oral CGRP-antagonist medication that had caused some liver toxicity and had to be shelved. I also had thought that the oral versions were preventative in nature, like the sub-cu or IV injections to be given monthly that we've all been discussing. However, H said that the new medication is an abortive, and the results for most have been the same or better (in fact, usually better) than whichever triptan the subject had used previously.

Like the last study I participated in, there would be few restrictions. The supplements I take for prevention could be continued, and she said the Phase 3 trial had just been opened up to those who had participated in previous CGRP studies. The trial period is twelve months, and I asked what would happen if I were in fact able to have erenumab prescribed during that time. She told me that in that case I would have to drop out, but that dropping out at any time for any reason is never a problem.

I told her with mounting excitement that I was ALL IN. She was able to schedule me for the following week, and so within days I was making the long familiar drive, in the pouring rain and fog, to the clinic where the magic happens.

Clinical trial paperwork and screening

It started out similarly to the other two studies. I signed some paperwork and answered questions to eliminate any possibility of depression and suicidal thoughts. Oddly, the first question on the suicide survey was “Have you ever had an accident?” I'm sorry, WHAT? I feel fortunate that H is a personal friend, who can guide me through some of the more odd aspects of this particular drug company's procedure. It is a drug company I had never heard of, as a matter of fact.

I had blood drawn. H told me that the company is excluding anyone with liver enzymes that are even a few points off, maybe due to the previous oral formulation's effect on the liver. I gave a urine sample, had an ECG, and was evaluated by a neurologist who shined his dastardly pen light into my each of my eyes for far too long. Since I haven't heard anything, I'm assuming all of my blood work passed inspection.

electronic diary
My electronic diary

Establishing a baseline

The first month is to establish a baseline of how many migraine days I experience and what I take for them. H programmed the electronic diary, which is actually just an Android phone this time, and told me that the daily questionnaire is very simple. I keep it plugged in, and I can only enter my info at 6:00 pm or later and there is a little whistle alert to remind me. I write the medications I take on a physical paper chart. At the next appointment, I will receive a bottle containing 30 pills. I am supposed to be limited to one each calendar day, even if that means I take one at 11:00 pm and another at 1:00 am. The study is for individuals with 9 to 14 migraine attacks per month. Once I have the study medicine, I am to stop taking sumatriptan (if I have any) or opioid rescue medication. But I will be allowed muscle relaxers, antiemetics (for me that means Zofran and Phenergan), acetaminophen (only two days per week), and NSAIDs (no limit was given but I can't take them anyway).

No reports of rebound or medication overuse headache

The most amazing thing is that no one has reported any signs of rebound (or “medication overuse headache”) from these pills. Conceivably, that means that if there are five migraine days in a row, the CGRP abortive can be taken all five days with no risk of beginning the medication/pain cycle most of us are all too familiar with. Some of H's patients reported fewer migraine attacks over time throughout the study, as though the abortive medicine worked a bit like a preventative, just like the preventative seemed to treat head pain I had at the time of the injection.

Promising results

I did ask H what I should do, or what my options would be, if the study medicine simply didn't work, or work as well as I needed it to. She told me that hadn't happened to anyone. One of her patients had dropped out of the study not because the CGRP pills weren't effective, but because she preferred the Maxalt she normally took (maybe she had the orally disintegrating ones). But no one reported it not relieving their pain and other symptoms; and most even stated that the head pain recurrence rate was much less than they were used to with their triptan medication.

I am personally so excited for all of us! After years and lifetimes of suffering with no preventative medications made specifically for migraine, and so many people in the migraine community unable to tolerate triptans due to heart or blood pressure issues or other side effects, we are approaching a time in the next few years when we will have choices. And they are all good ones. Lasmiditan, a serotonin receptor agonist like the triptan meds but without vasoconstriction; and now also a CGRP antagonist, both abortives, are said to be heading for approval in 2018 and 2019, respectively. And the first CGRP preventative may be released within the next couple of months. It's a whole new world of hope.

And of course, I will keep you updated on my experience with this clinical trial, just as I did with the last one. Stay tuned!

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