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CGRP Drug for Chronic Migraine: Very Promising Study Results

cgrp-drug-for-chronic-migraineAmgen’s CGRP drug provided significant relief to participants with chronic migraine, according to new study results presented at an international conference in mid-September. The drug, called erenumab, was tested at two doses, 70 mg and 140 mg. “Both doses of erenumab were associated with significant improvements in health-related quality of life, headache impact, disability, and level of pain interference, compared to placebo,” according to Amgen’s press release announcing the study’s results.

Here’s a brief summary of the study’s details and it’s findings.

In the 12-week study, 667 participants were given monthly injections of either the drug, called erenumab, or a placebo. The breakdown was:

  • 191 participants received 70 mg erenumab
  • 190 participants received 140 mg erenumab
  • 286 were injected with the placebo

All participants had chronic migraine. At the start of the study, they had an average of 18 migraine days per month and 21.1 headache days each month. The following outcomes were assessed during the last four weeks of the study.

  • Reduction in migraine days per month: Those who were given erenumab (at either dose) had an average of 6.6 fewer migraine days a month.
  • 50% or greater reduction in the number of migraine days per month: 40% of participants who received the drug at 70 mg and 41% who got 140 mg had their number of headache days decreased by at least half.
  • Reduction in use of acute migraine drugs (abortives): Participants who received 70 mg of erenumab took abortives on 3.5 fewer days; those who received 140 mg reduced their medication use by 4.1 days.
  • Reduction in headache hours: Participants who received 70 mg of erenumab had 64.8 fewer headache hours in the month; those who received 140 mg of erenumab had 74.5 fewer headache hours.

Side effects

No adverse effect was reported in more than 5% of the participants. Those reported were:

  • Injection site pain: 3.7% in participants who received the active drug at either dose; 1.1% placebo
  • Upper respiratory tract infection: 2.6% at 70 mg; 3.7% at 140 mg; 1.4% placebo
  • Nausea: 2.1% 70 mg; 3.2% 140 mg; 2.5% placebo

This yet is another promising report on the CGRP drugs that are in development for migraine prevention. All studies so far have found a notable reduction in migraine frequency and improvement in health-related quality of life for a significant portion of participants. Minimal side effects have been reported thus far. This was a Phase 2 study. Phase 3 studies, which are underway now, will include more participants and give us more information on side effects.

(Amgen has also issued a press release about the first CGRP drug Phase 3 results I’ve seen. Participants in the study had between four and 14 migraine days a month. Those given erenumab had an average of 2.9 fewer migraine days per month. With such a wide range in migraine frequency, it’s hard to tell how impressive that number is. But even for someone with 14 migraine days a month, the average would mean about 20% fewer migraine days.)

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Migraine Medication Detox, Week Two: Transition Period

migraine medication detox“This too shall pass.” Those words provide immense comfort when my migraine attacks are severe and disabling. They have carried me through many difficult years. As encouraging as this phrase can be, there’s a flipside to it: the difficult, trying times in life pass, but so do the pleasurable ones we never want to end. “This too shall pass” means that everything passes.

When I had migraine attacks last Sunday and Monday after having a remarkable few days, I was too busy panicking to remind myself that they would pass. My mind churned on my most fear-filled thoughts: What if my new treatment isn’t working? What if it’s making me feel worse? What if I will never again feel as good as I did these last few days?

Although I was 100% sure I was overreacting, that did nothing to assuage my fears. My worry settled a bit on Tuesday after I stopped the oxytocin (which was definitely a migraine trigger for me), but I continued to fret.

I didn’t remember that this too shall pass until Wednesday. That’s when I finally realized that detoxing from medication overuse headache and trying new meds mean I’m in a transition period. That should have been obvious, but I was so caught up in excitement—and then the fear—for the future that I wasn’t paying attention to the present. I’d forgotten that progress is not linear.

“Transition period” became a mantra of sorts in the last week. When I start to panic, I remind myself that I could still be detoxing from my meds (especially since I gave in to Amerge last Monday) and that the effects of my new treatment tends to build over months. Even more turbulence comes from experimenting with new treatments (Compazine, oxytocin, and some new-to-me preventives), changes in my meal frequency, and introducing new foods. I still have a ton of variables to work out. “Transition period” is now shorthand to remind myself that it will take time to sort out all these confounding factors.

It’s kind of an odd mantra, but I like its hopefulness. It tells me that I’m on my way to somewhere new, somewhere that could be great. (It could also be awful, but I’m not dwelling on that.) This too shall pass. I have no idea where I’ll be when it does. That’s a little scary, but it’s mostly exciting.

Learn more about my migraine medication detox:

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Migraine Medication Detox, Week One: Easier Than Expected

migraine medication detoxMy first week of migraine medication detox began with a final dose of Amerge (naratriptan) and two Midrin after breakfast on Sunday, August 21. Despite a rough start, the week’s been surprisingly easy.* I feel better than I have in almost two years! Here’s how the week of detox went.

The treatments to get me through the week were:

  • Compazine 30 minutes before each meal. Although it’s a nausea med, some people get migraine relief from Compazine. (It only made me tired and helped the nausea; it did not give me any migraine relief.)
  • Oxytocin as an acute medication once a day. (Which I discovered is a migraine trigger for me.)
  • A new treatment I’ve been using since June 22. It is a preventive treatment that can also be used acutely. That’s all I can tell you right now, but will share more as soon as I can.

Day 1: Monday was the worst day by far. I was too nauseated and dizzy to eat breakfast until 1 p.m. and that required dosing with Zofran and Compazine. The pain, which felt cold and high on my head, hovered around a 4 and peaked at a 5, which lasted a couple hours. Ice exacerbated the pain. Thanks to Compazine, I slept from 2 p.m. to 7 p.m. I definitely had a migraine attack in the night and didn’t sleep well (probably because of the Compazine-induced nap).

Day 2: I started Tuesday with a decent amount of energy and little pain. I even showered and did housework before eating. The migraine attack that followed breakfast was slight, but definitely present. Between it and the Compazine, I was laid up until I took a nap. Within 30 minutes of waking from my nap, I was perky and functional. I spent three hours working on chores and even did some writing. All with overcast skies! I once again had a migraine attack in my sleep, but it didn’t keep me up. Night sweats and vivid dreams were the only evidence that an attack happened at all.

Day 3: I switched from taking oxytocin at night to taking it after breakfast on Wednesday. It was a remarkably good day. I slowed down for a couple hours after eating, but am unsure if migraine or Compazine was the culprit. I even ran errands in the afternoon. After dinner was the first time I felt like my new treatment actually aborted a migraine attack! It was also the first night in almost a year where I didn’t fall asleep minutes after getting into bed.

Day 4: I woke up feeling fine Thursday and skipped the pre-breakfast Compazine hoping that I would be less sluggish without it. I used my new treatment after eating and it once again appeared to abort the migraine attack. I felt a little slow for maybe an hour afterward, but was able to write all day. My mind got a little fuzzy in the late afternoon, so I decided to rest. Before I did, I cleaned up a mess in the laundry room and put a coat of sealant on the bathroom tile… and discovered I no longer needed to rest. I finally stopped “doing” for the day at 7 p.m.

The other big news of the day: I ate three meals instead of two! I can use my new treatment three times a day, so I wanted to see if it would abort all three eating-triggered attacks. It did!

I then stayed awake the entire night. It wasn’t one of those maybe-I-slept-maybe-I-didn’t kind of nights. I read and did housework all night long. What kept me up? NOT having a migraine attack. I’m one of those fortunate folks who gets sleepy during an attack. After 17 months of nightly attacks, I think my body had gotten used to using migraine as a sleep aid.

Day 5: Despite not sleeping one wink, Friday was another remarkable day. It was house-focused, including signing the paperwork to have the grass removed from our yard and replaced with waterwise plants. (I’m so excited!) And I finally fixed the mess created when shelves in the laundry room fell a few months ago. Nothing to write home about… except that having a day of normal chores is absolutely worth writing home about.

I’m trying to temper my excitement about how much better I feel (Hart is, too). I feel so different, so much better, that I want to believe the ketogenic diet, my new treatment, and getting out of MOH have made a huge, lasting difference. And maybe they have, but I don’t want to go (too far) down that path until I have more data. I don’t want to be (too) crushed if this improvement turns out to be a fluke. Then again, I know my body really, really well. This feels different. (I might hate myself later for writing those words.)

Day 6: I felt great all day Saturday! I woke up at 8 a.m. and organized the house until 11 p.m. I didn’t even check Facebook. I slept well, too.

Days 7 & 8: Both days started well, but migraine attacks crept up through each morning. Both attacks made me so tired I couldn’t avoid napping. Both times, the migraine attack lifted within 30 minutes of waking up. Napping usually gives me some degree of migraine relief, but it only began aborting attacks completely this summer. I’m still surprised when it happens. (I was so afraid of losing another day that I took one Amerge (naratriptan) as soon as I felt symptoms on Monday. My background headache was more painful that day.)

Day 9: I spent this morning preoccupied with Sunday and Monday’s migraine attacks and obsessing over whether an attack was coming on. As I sifted through potential triggers, I kept worrying that my new treatment is backfiring. Although that is unlikely (I’ve been using it for two months with no problem), it’s my biggest fear, so it’s what my mind settled on. Other possibilities are that oxytocin is a trigger, I’ve developed reactions to some foods I thought were OK, or that merely touching cleaning product bottles now triggers attacks. I went with the oxytocin hypothesis and skipped my dose this morning. I’m going strong at 3 p.m., so I’m guessing oxytocin was the culprit.

Future weeks: Medication overuse headache symptoms can last six months after the final dose. Given how easy my migraine medication detox has been and that I’ve only been using excessive amounts of medications for 16 months, I doubt I’ll have symptoms that long. Still, I’m hopeful that the next few weeks or months could bring even more improvement. Maybe I’ll one day be able to eat without having a migraine attack at all.

*My experience does not represent the typical migraine medication detox. It has been easy because of the preventives I was on before I started (and possibly because I was only in MOH for a year). The drugs I used as a bridge were ineffective—Compazine only made me sleepy and oxytocin made my migraine attacks worse. In the six months before starting the detox, my pain rarely got above a 4 and my most disabling symptoms were fatigue and cognitive dysfunction.

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Migraine Medication Detox: Getting Started

migraine medication detoxI’ve been taking an Amerge (naratriptan) and two Midrin twice a day since April 2015. The medications allow me to function, but have the potential to increase the frequency, severity, or duration of my migraine attacks through medication overuse headache (MOH), which is also called rebound headache. My headache specialist is aware of my medication use. We discuss its potential impact at every appointment and he reiterates that the odds of it being a problem for me are quite low. Although my history showed MOH was unlikely to be a concern for me, I was still concerned. With my doctor’s consent, I persisted taking the drugs because they were the only way I could function.

Since eating anything is my migraine trigger and no preventive medications have been able to address that issue, I feel stuck. Going off the medication is not going to stop eating from being a migraine trigger. But my last visit with my headache specialist got me thinking about the two treatments I’ve been trying this year. One is the ketogenic diet and the other I can’t tell you about yet. Both have helped a small amount, but neither has had a huge impact. They have helped enough that I don’t want to stop either one, but I’m having trouble quantifying the extent of each one. What if MOH is somehow keeping me from realizing the full benefit of either or both treatments?

What if…? When a question like that lodges itself in my mind, I have to learn the answer. My migraine medication detox began last night.

My doctor offered to admit me to the hospital to keep me comfortable through detox. I declined because I don’t think I need it. Instead, I will take Compazine (prochlorperazine) 30 minutes before meals and use an oxytocin nasal spray after the migraine attacks begin. Compazine is known as a nausea drug, but it can also help reduce migraine symptoms. Oxytocin is being studied as a potential acute migraine treatment and could also have preventive effects. If my migraine attacks take a sharp turn for the worse, I’ll add DHE or Migranal to the lineup (assuming they aren’t out of stock). I have the option of starting another preventive at the same time, but think I’m going to wait in an attempt to control variables.

If you’re reading this to learn how to do a migraine medication detox with as little pain as possible, please be aware that my treatment may not be an applicable template. For most people with MOH, going off the medications would result in horrendous pain. My symptoms and situation are different than most. Thanks to my current preventive treatments and dietary restrictions, my pain rarely gets above a 3 on a 0-10 scale. I expect that it won’t exceed a 6 even while detoxing. Fatigue and cognitive dysfunction have been more disabling than the pain for me for the last few years. Those symptoms will be bad, but as long as I can feed myself and plan to limit my work for a couple weeks, detox shouldn’t be too bad for me.

I very much want to discover that MOH has crept up on me and is keeping two somewhat effective treatments from reaching their full potential. But I’m not holding my breath. I suspect I’ll go through migraine medication detox and discover that I still have a migraine attack every time I eat. While the acute medications may be increasing my susceptibility to migraine attacks outside of eating, they are also managing the attacks I get twice a day no matter what. My best hope is that the ketogenic diet and the other treatment are far more effective than I think because MOH is hiding their efficacy. Or maybe oxytocin will provide great relief. Whatever happens, I’ll have at least one more data point to help determine what my next course of action will be.

(Pardon any typos. Editing is beyond me right now.)

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Your Guide to Getting a Spring TMS

getting-a-spring-tmsA non-drug treatment with few reported side effects that works as both an acute treatment for migraine attacks and a migraine preventive. That describes the Spring TMS, which received FDA approval in 2014 and is slowly becoming available throughout the country. Compared to other technologies, Spring TMS’s rollout has lacked much fanfare, but it’s a pretty exciting treatment with a long history of research to support its use.

Transcranial magnetic stimulation (that’s what TMS stands for) uses a very short magnetic field to send a brief energy pulse through the skull into brain tissue. The pulse causes very mild electrical currents in the brain that are believed to stop a migraine attack by interrupting the abnormal electrical activity in the brain caused by migraine.

My experience with Spring TMS might make you wary. I believe the worsening of my migraine attacks while using it was coincidental, not caused by the device itself. I still advocate for trying it because the research on Spring TMS is quite strong. I also advocate for talking to your doctor about what to do if your head pain worsens while using the device.

Here’s what you need to know for getting a Spring TMS, from which doctors can prescribe it and learning how to use it to its cost and how the rental program works. It contains an exact transcript of the questions an eNeura executive answered for me in April.

Kerrie: Can any doctor prescribe Spring TMS? If not, how can a patient choose a doctor to prescribe it?

eNeura: The device is currently available by prescription in specialist headache centers around the US. If you want to see which doctors near you can prescribe the Spring TMS email customercare@eNeura.com or call 1(408) 245-6400, and press 1 to speak with a Customer Care representative. Doctors who are interested in prescribing the device can also email or call eNeura customer care.

How much does it cost?

Spring TMS is available by prescription under a rental program. The cost is comparable to other prescribed migraine treatments. The company offers a $300 discount off the first 3 months for new patients. A new 3 month prescription is $450 ($150 per month) plus a one time $50 shipping charge. Total charges for the first three-month period come to $500.

[The above pricing only applies for the first three months of use. Here’s updated pricing information from eNeura’s customer service department, current as of Aug. 24, 2016: We rent the device in 3-month increments.  At list price, the cost per month is $250. A patient who selects the 12-month option will average $175 per month for SpringTMS. We also offer new patients a $300 discount on their first prescription, which would bring the cost per month down from $250 to $150 for that first prescription.]

Does insurance cover SpringTMS? 

As a new migraine treatment, insurance coverage for Spring TMS varies and will likely require documentation of medical necessity from the prescribing physician. eNeura has retained an insurance reimbursement consulting service for patients wishing to pursue insurance coverage. eNeura Customer care will help you get started. Call 1(408) 245-6400, and press 1 to speak with a Customer Care representative.

Do you bill insurance? If not, have patients been successful applying for reimbursement from insurance companies?

eNeura does not bill insurance companies, but patient’s can submit invoices to their insurance company for potential reimbursement.

How does the rental program work?/How does a patient renew a prescription?

eNeura: Near the end of the three-month period, the patient’s doctor can send a renewal prescription to eNeura. eNeura, in turn, emails an invoice for the renewal period. Once that’s paid they will mail a new SIM card to replace the original SIM card in the machine. If the prescription is not renewed and the new data card is not inserted in the Spring TMS unit, it stops working. 

Is special training required to learn how to use the device?

It is easy to use and is fully automated to guide the patient through treatment in a step-by-step fashion. While there is no special training required, eNeura offers an individualized program to support you as you begin using the Spring TMS.

A Clinical Education Consultant will contact you when your Spring TMS arrives to help you get started and answer your questions. During your first 3-4 months of use, your nurse will continue to support you in your treatment plan, answer your questions, review your diary and report your progress to your doctor. 

Is the unit shipped directly to the patient or does it go through the doctor?

Prescribing doctors send the three-month prescription to eNeura. Once the prescription is received, eNeura prepares the device and ships it directly to the patient’s home.

If a patient stops using the device, how do they return it?

When a patient receives their SpringTMS in the mail they are instructed to keep the original packaging. If a patient stops using the device, it needs to be shipped back to eNeura. Contact eNeura Customer Care to obtain a prepaid return shipping label. There is no charge for returning the device.

What else would you like patients to know about SpringTMS?

Many migraine patients are looking for non-drug treatment options. For them medications either don’t work… may be contraindicated or just not well tolerated. SpringTMS offers a safe clinically proven treatment option without medication side effects.

Longtime reader Timothy Bauer checked in with eNeura on July 20 after reading my article on Migraine.com. He was told that doctors who have not already been trained in prescribing the device may have to wait several months for training. The company gave him the names of doctors in his area who have already been trained.