New treatments | Headache NewsBlog

Rimegepant for trigeminal neuralgia: a case report

By: Dr. Mauskop

18-07-2022

Brain disorders, New treatments, Pain, Trigeminal and other neuralgias

A case report presented at the annual meeting of the American Headache Society described a patient with trigeminal neuralgia (TN) whose pain responded well to rimegepant (Nurtec). Rimegepant is a drug approved for the acute and preventive treatment of migraines. This patient did not obtain relief from surgery and several medications. He was taking 300 mg of oxcarbazepine, buprenorphine (narcotic) patch, and up to 120 mg of oxycodone with partial relief. Within 12 hours of starting rimegepant he was pain-free. In the six months of taking rimegepant he experienced very infrequent and mild pain.

There have been several reports indicating that injections of CGRP monoclonal antibodies such as erenumab can relieve the pain of TN. So it is not surprising that an oral CGRP drug helped this patient.

I’ve treated several TN patients with CGRP antibodies. One such patient has been receiving injections of galacanezumab for over 3 years. He requires injections of 240 mg every 3 weeks and also has to take daily medications. This combination has allowed him to be fully functional and to keep his job. I may now try him on an oral CGRP drug.

In addition to rimegepant, there are two other oral CGRP drugs – ubrogepant (Ubrelvy) and atogepant (Qulipta). They are very similar but many patients have a clear preference for one over the others. It may be worth trying them all if the first drug is not fully effective. A major obstacle to using these medications “off label” for TN is their high cost.

CGRP monoclonal antibodies in pregnancy

By: Dr. Mauskop

09-05-2022

Chronic migraine, Headache medications, injections, Migraine, New treatments

Not surprisingly, none of the new migraine drugs have been tested in pregnant women. No new drug for any indication is ever tested for its safety in human pregnancy. They are always tested in pregnant animals, which helps weed out most drugs that are clearly dangerous. It takes decades to learn if a drug is safe. This happens through an accumulation of anecdotal reports and pregnancy registries that are usually run by drug manufacturers.

Erenumab (Aimovig) was the first CGRP monoclonal antibody to be approved for the preventive treatment of migraines four years ago. It was tested in pregnant monkeys who were given 50 times higher doses (by weight) than the FDA-approved dose for humans. Even though some of the medicine crossed the placenta into baby monkeys, they had no developmental problems.

In the current issue of Headache, University of Texas doctors published a report of a woman who continued to inject herself with erenumab throughout the duration of her pregnancy. She tried to stop the drug before planning to get pregnant but her severe migraines recurred. Her baby was born healthy and had normal development by the last evaluation at 6 months of age.

This case report is the first very small but important step in the process of evaluating the safety of erenumab in pregnancy.

In humans, the transfer of antibodies, which are large molecules, across the placenta is very limited before the 16th week of pregnancy and increases after the 22nd week. We still recommend stopping the drug about five months before a pregnancy is planned. If a woman, however, does get pregnant, intentionally or not, the risk of complications is low if erenumab is stopped within the first three months of pregnancy. This also applies to all other monoclonal antibodies in general and specifically other migraine drugs – galcanezumab (Emgality), fremanezumab (Ajovy ), and eptinezumab (Vyepti).

What to do if Emgality, Aimovig, and Ajovy do not last a full month

By: Dr. Mauskop

14-04-2022

Chronic migraine, Migraine, New treatments

Yesterday I saw a 48-year-old man who has been suffering from migraine headaches since his teens. He did not respond to a wide variety of drugs and non-drug therapies, but Emgality has been very effective. The only problem is that the effect lasts three and a half weeks. During the week before the next shot, his migraine headaches become severe and frequent. Sumatriptan helps but his disability as measured by the MIDAS scale is in the moderate range. He is a high-level executive in a large corporation and needs better control of his migraines. He had tried the other two monoclonal antibodies for migraines – Aimovig and Ajovy – and they were less effective.

Fortunately, there is a good solution to his problem. I advised him to take Emgality injections every three and a half weeks. This is a higher frequency than what is recommended by the FDA and some doctors and patients may have concerns about the safety. The one-month interval is based on averages derived from large studies. People, however, are not average. Some metabolize drugs faster or need a higher or a lower dose of a drug. Another reassuring fact about Emgality is that it is approved at a much higher dose for cluster headaches. For migraine, we give a 240 mg loading dose and then, 120 mg monthly. Patients with cluster headaches get monthly injections of 300 mg.

I have patients who have the same problem of the short duration of effect with Aimovig and Ajovy as well.

A major obstacle to the more frequent use of these drugs is the fact that insurance companies will only pay for 12 shots a year. These drugs cost about $600 to $700 a dose, so the cost is a major factor for many people. The way I get around it is by providing patients with free samples. Because we have three similar competing drugs, we get samples of all three. If you are having a similar problem, ask your doctor for a free sample. Some academic centers and large hospitals do not allow doctors to receive samples but most doctors in private practice can get them.

Attend RetreatMigraine, online or in person

By: Dr. Mauskop

17-03-2022

Headaches, Migraine, New treatments, Psychology of headaches

I am honored to speak (in person) at this patient advocacy event. My topic will be, When treatments stop working, what’s next?

Here is some information and a link:

RetreatMigraine 2022: April 1-3 at Hilton Charlotte University Place
RetreatMigraine is a conference specially designed by and for adults living with migraine disease. The multi-day event brings together patients, care partners and migraine experts to support and strengthen our community. In 2022 RetreatMigraine will be a hybrid event. In-person capacity is for 300+ attendees and virtual capacity is unlimited. The conference offers interactive sessions that provide disease and treatment education, advocacy training and complementary therapy experiences.
This conference is organized by CHAMP – Coalition for Headache and Migraine Patients.

Combining peripheral electrical stimulation with relaxation training to treat migraine headaches

By: Dr. Mauskop

17-02-2022

Alternative Therapies, Migraine, New treatments, Psychology of headaches

Nerivio, an electrical stimulation device was cleared by the FDA to treat acute migraine attacks in adults almost three years ago. It was recently also cleared to treat migraines in adolescents. A new study sponsored by Theranica, the manufacturer of Nerivio shows that combining this device with relaxation and education improves its efficacy.

Remote electrical neuromodulation (REN) is the official term for passing an electrical current through the arm in order to treat migraine headaches. Theoretically, other painful conditions can be also treated by electrical stimulation applied outside of the area of pain. Currently, however, there is only only one such device, Nerivio, and it is used to treat migraine headaches.

I’ve prescribed this device (and it still needs a prescription) to hundreds of patients. About half of them find it effective and continue using it. Some of my patients have remarked that not only their migraine improves, but they also feel more relaxed. I was a bit surprised because they are supposed to crank up the current to the point just below where it becomes painful. But even if you don’t feel relaxed, it makes sense for all patients to try to relax during this treatment which typically takes 45 minutes.

Theranica sponsored a trial that combined electrical stimulation with what they call Guided Intervention of Education and Relaxation (GIER). This consisted of a 25-minute video played on the user’s smartphone during the treatment. It trains patients in three relaxation techniques: diaphragmatic breathing, progressive muscle relaxation, and guided imagery. It also provides pain education about migraine biology and electrical stimulation.

The results of this trial were just published in the journal Pain Medicine. The lead author, Dr. Dawn Buse is a psychologist and one of the leading headache researchers.

The results in the group that used only Nerivio were consistent with those found in previous controlled trials – 57% of patients had consistent pain relief in more than 50% of their attacks, 20% had complete elimination of pain, 53% had improvement in function, and 18% were able to return to normal functioning within 2 hours after treatment.

Patients who combined Nerivio with GIER did better. 79% had pain relief, 71% had improved functioning, and 38% returned to normal functioning.

Nerivio is used through an app that is downloaded into a smartphone. This gives the company a perfect opportunity to easily enhance the efficacy of its product.

Intranasal ketamine for cluster headaches

By: Dr. Mauskop

20-01-2022

Alternative Therapies, Cluster headaches, Headache medications, New treatments

Cluster headaches are considered to cause the worst pain imaginable. We have a variety of medications – both acute and preventive – that help relieve the pain of cluster headaches. For some, none of these treatments work and we do need additional medications. Ketamine could be one such drug.

Ketamine has been in use for over 50 years. Its main indication is intravenous anesthesia. Recently, the FDA approved ketamine nasal spray for depression. It is also being widely used intravenously and by mouth for depression, chronic pain, and migraine headaches. A group of researchers at the Danish Headache Center in Glostrup, Denmark tested the efficacy of ketamine nasal spray for the acute treatment of cluster headaches.

Anja Petersen and her colleagues selected 20 cluster patients whose attacks did not respond sufficiently well to sumatriptan or oxygen – the two most effective acute therapies for cluster headaches. Patients treated a single cluster attack with 15 mg of intranasal ketamine. They could repeat this dose every 6 minutes, for up to 5 times. Four patients took another medication after 15 minutes. Of the 16 remaining ones, 11 had a drop in pain severity by an average of four points, to four or lower on a one to 10 scale. Half of the patients preferred ketamine to oxygen and/or sumatriptan injection. No patient had any serious side effects from ketamine during the trial.

Ketamine nasal spray that is approved for depression is a more potent version of ketamine called esketamine (Spravato). It is a patented and branded product and it is very expensive. Ketamine itself, however, is a cheap drug. A compounding pharmacy can prepare a nasal spray for as little as $60 for a month supply. Most insurers do not cover compounded drugs, so you’d have to pay for it.

Marijuana increases the risk of car accidents

By: Dr. Mauskop

13-01-2022

Alternative Therapies, Brain disorders, Migraine, New treatments, Pain

I’ve been prescribing medical marijuana (MM) since 2016 when it became legal in New York. We still lack controlled clinical trials of MM for the treatment of migraines. Most of my patients who find MM useful report that it relieves nausea or anxiety, helps them go to sleep and sometimes relieves pain. Others find that taking it daily prevents migraines. CBD alone can be also helpful, but most patients need a combination of CBD and THC as well in order to obtain a therapeutic effect.

Like any other drug, MM can have side effects. One of them is cognitive impairment. A study just published in the New England Journal of Medicine describes the effect of recreational marijuana legalization in Canada on injuries to car drivers. The researchers studied drivers treated after a motor vehicle collision in four British Columbia trauma centers from 2013 through 2022. They discovered that after legalization, the number of moderately injured drivers with a THC level above the legal limit doubled. The largest increase was seen in older and male drivers.

This is relevant to the users of MM as well. From now on, I will caution my patients not to drive after taking any THC-containing products. Just like with alcohol, you don’t need to have a blood level above the legal limit to slow your reflexes.

Repetitive transcranial magnetic stimulation relieves migraines

By: Dr. Mauskop

18-12-2021

Alternative Therapies, Headaches, Migraine, neurostimulation, New treatments

Magnetic stimulation with a single pulse has been shown to be effective in aborting a migraine attack with the eNeura Spring TMS device.
Repetitive magnetic stimulation (rTMS) of the brain has been shown to relieve depression. A pilot study just published in the journal Brain Stimulation examined the effectiveness of repetitive magnetic brain stimulation for the prevention of migraine attacks.

German and Moldovan researchers conducted a double-blind, randomized controlled study in patients with episodic migraine. They compared real and sham stimulation in 60 patients. Participants received six treatment sessions over two weeks. The primary outcome measure was the number of patients whose migraine days dropped by 50% or more. The frequency and intensity of migraine attacks over a 12-week period were also assessed.

Real rTMS produced at least a 50% reduction in migraine days in 42%. This number was 26% in the sham group. The mean migraine days per month decreased from 7.6 to 4.3 days in the real rTMS group and from 6.2 to 4.3 days in the sham rTMS group. The reduction in migraine attack frequency was also higher in the real rTMS compared to the sham group. No serious adverse events were observed.

There are a couple of practical issues with this treatment approach. The rTMS equipment is already being used for depression, which in theory should make it easy to adapt for migraines. However, this treatment is time-consuming and expensive and is not likely to be covered by insurance. Another problem, which we also encountered in our study of transcranial direct current stimulation, is that there are many variables to consider. Placement of electrodes, the strength of stimulation, frequency, and duration of treatments are some of these variables.

Dr. Mauskop to speak on refractory migraines in Zurich, Switzerland

By: Dr. Mauskop

14-10-2021

Chronic migraine, Headaches, Migraine, New treatments

I am honored to participate in a symposium on headache management,
“THE CHALLENGE OF MIGRAINE AND CLUSTER HEADACHES”. The title of my presentation is The challenge of migraine: new perspectives in refractory cases

This interactive neurological conference will be held in-person on Thursday, November 4, 2021 at the Zurich Marriott Hotel, Zurich, Switzerland

A new, better DHE nasal spray is approved for acute migraines

By: Dr. Mauskop

06-09-2021

Chronic migraine, Headache medications, Headaches, Migraine, New treatments

Trudhesa is a new formulation of dihydroergotamine (DHE) nasal spray just approved by the FDA. It appears to be more effective than the original DHE nasal spray (Migranal) that was introduced in 1997.

Ergotamine, the first migraine-specific drug was developed in 1926. It is still available in tablet form but is not widely used because it causes nausea, constriction of blood vessels, and other side effects. DHE, approved in 1946, was the first synthetic migraine drug. It was derived from ergotamine in an attempt to reduce side effects. DHE is not effective when taken by mouth and was originally approved for intravenous use. It is still being used now – 75 years later – intravenously, intramuscularly, and subcutaneously. DHE injection is a very effective medicine, often used when no other migraine drug provides relief. It does cause nausea and vomiting in a significant number of patients. This is why it is often given along with an anti-nausea drug such as ondansetron (Zofran), prochlorperazine (Compazine), or metoclopramide (Reglan).

The original DHE nasal spray has been a relative disappointment. It is not very effective, although there are some patients for whom it works well. Despite being on the market for over 20 years, it is still very expensive – $100 a dose. The manufacturer of Trudhesa, which is a better product than Migranal, is promising to make their product more affordable. Nasal delivery of DHE causes less nausea than an injection.

Trudhesa is more effective despite delivering a smaller dose of DHE than Migranal. This is because Trudhesa is delivered as a fine mist into the upper reaches of the nasal cavity. It will become available in about two months. I will prescribe it to patients for whom oral medications are ineffective.

Nurtec is the first drug approved for acute and preventive treatment of migraines.

By: Dr. Mauskop

27-05-2021

Chronic migraine, Headache medications, Migraine, New treatments

Biohaven, the manufacturer of rimegepant (Nurtec ODT) just received FDA approval to market this drug for the prevention of migraines. Rimegepant was approved in January of 2020 for the acute treatment of migraine headaches. It is the first drug to be approved for both acute and preventive therapy of migraines.

Rimegepant is one of six drugs that block the action of calcitonin gene-related peptide (CGRP). CGRP has many important functions in the body but the release of excessive amounts of it in the brain can trigger a migraine. Four of the CGRP migraine drugs are given by injection and they are used only for the prevention of migraine attacks. Rimegepant and ubrogepant (Ubrelvy) are taken by mouth as needed, whenever a migraine strikes. These are truly novel drugs that have dramatically improved the lives of many migraine sufferers.

Rimegepant stays in the body longer – it has a half-life of 10-12 hours, while ubrogepant’s half-life is 7-8 hours. Another difference is that rimegepant dissolves in your mouth (ODT after Nurtec stands for orally disintegrating tablet), while ubrogepant is a solid tablet that is swallowed.

In clinical trials, rimegepant was noticed to provide relief of migraine that persisted for up to 48 hours. Because of this sustained effect, the researchers decided to test this drug for the prevention of migraine attacks by giving it every other day. And rimegepant passed this test. The official FDA-approved label says that for the prevention of migraines, one tablet of rimegepant should be taken every other day. For the acute treatment of migraines, the directions say to take 1 tablet a day, as needed.

The insurers typically pay for 8 tablets a month, although a few of my patients have been able to get 16. Now, with its approval for the prevention, patients will be able to get 16 tablets a month. It is possible that some patients may be able to get an additional 8 tablets for acute therapy. For most, however, 16 tablets a month should be sufficient.

The safety profile of rimegepant (as well as ubrogepant) is truly remarkable. The new rimegepant label states that “The most common side effects of NURTEC ODT were nausea (2.7%) and stomach pain/ indigestion (2.4%).” It also states that these are not the only possible side effects but their frequency is very low. Just like with any drugs, an allergic reaction is also possible.

Melatonin for migraines

By: Dr. Mauskop

11-09-2020

Alternative Therapies, Migraine, New treatments

Melatonin is a hormone produced by the pineal gland located in the brain. The release of melatonin helps us fall asleep. Melatonin supplements have been used to treat insomnia. The results of clinical trials, however, are contradictory. This may be because a wide variety of doses have been used. One study suggests that 3 mg of melatonin – a common dose sold in stores – is less effective than 0.3 mg. I usually recommend 0.3 mg (300 mcg) for both insomnia and jet lag.

Melatonin has been tested for the prevention and acute treatment of migraines.

Melatonin was not effective in a study by Norwegian doctors. They gave 2 mg of extended-release melatonin every night for 8 weeks to 46 migraine sufferers. All 46 received also received 8 weeks of placebo in a double-blind crossover trial. Migraine frequency did improve from an average of 4.2 a month to 2.8 in both the melatonin and the placebo groups.

Another blinded trial was done in Brazil by Dr. Mario Peres and his colleagues. It compared 3 mg of immediate-release melatonin with a placebo and with 25 mg of amitriptyline. The study involved 196 patients. The number of headache days dropped by 2.7 days in the melatonin group, 2.18 for amitriptyline, and 1.18 for placebo. Melatonin significantly reduced headache frequency compared to placebo. Amitriptyline did not. Not surprisingly, melatonin was much better tolerated than amitriptyline. Considering its safety and very low cost, it is worth considering a trial of 3 mg of melatonin for the prevention of migraine headaches.

It is possible that, unlike with insomnia, a higher dose is more effective for the prevention of migraines. And, the immediate-release form could be more effective than the sustained-release one.

Melatonin may be effective as an acute treatment for pediatric migraine, according to a study just published by Dr. Amy Gelfand and her colleagues at UCSF. This was an 84-patient trial, although only 46 children completed it. Both low and high doses of melatonin were associated with pain reduction. Higher dose and napping after treatment predicted greater benefit. The benefit was likely an indirect one – melatonin helped children fall asleep and sleep, often in children but also in some adults, can relieve a migraine attack.