About MigraineThe World Health Organization (WHO) estimates a worldwide prevalence of current migraine of 10%, and a lifetime prevalence of 14%. It further classifies individuals who are suffering with migraines as debilitated as a quadriplegic. In the US it is estimated that more than 100,000 migraines occur every day. These attacks on an annual basis, leads to more than 150 million lost workdays and a loss of national productivity measured in tens of billions of dollars. Estimates of the total cost of migraine across Europe place loss at over 25 Billion Euros(1). Migraine is a term used to describe a class of recurrent headaches that are typically unilateral but may occur bilaterally. They may occur with or without recognized warning signs, including either prodromal symptoms or an aura phase. Prodromal symptoms consist of altered mood, irritability, depression or euphoria, fatigue, dizziness and other visceral symptoms preceding the headache by several hours or days. The aura phase, present in 20-30% of migraineurs, is a neurological symptom that generally precedes the migraine attack by 5-60 minutes. Auras can include visual disturbances such as photopsia or scotomas or in less frequent cases somatosensory, auditory or gustatory hallucinations.(2) The pathophysiology of migraine headaches is not clearly understood. Initially migraine headaches were thought to be of vascular origin. Recent evidence suggests the possibility of neurogenic causes. Whether these neurogenic causes are related to vascular change is still under investigation. There is no single standard of care for patients presenting with migraine symptoms, and treating acute migraine is challenging because of substantial nonresponse rates among medication users and difficulty in predicting individual’s responses to a specific agent or dose. Abortive therapy is typically suggested as early as possible after the onset of symptoms. Effective first-line therapies for mild to moderate migraine are nonprescription nonsteroidal anti- inflammatory drugs and combination analgesics containing acetaminophen, aspirin, and caffeine. Triptans, (a class of serotonin receptor agonists) are first-line therapies for moderate to severe migraine, or mild to moderate migraine that has not responded to adequate doses of simple analgesics. However, triptans have to be avoided in patients with vascular disease, uncontrolled hypertension, or hemiplegic migraine. There are restrictions as to how many triptans should be taken within a specific time period. Triptan overuse has also been implicated in increased frequency and severity of headache in some patients, a phenomenon termed medication overuse headache (which can be remediated only by discontinuation of any analgesia during migraine attacks for a period of up to three months). This is NOT a relevant clinical term or issue. The first combination product of a 5-HT1 receptor agonist and an NSAID, Treximet, was approved by the US Food and Drug Administration in April 2008. Efficacy was demonstrated in 2 randomized, double-blind, multicenter, parallel-group trials comparing the combination product to placebo and each individual active component (ie, sumatriptan and naproxen sodium). The percentage of patients remaining pain free without use of other medications through 24 hours postdose was significantly greater (p<0.01) among patients receiving a single dose of Treximet (25% and 23%) compared with placebo (8% and 7%) or either sumatriptan (16% and 14%) or naproxen sodium (10%) alone.(4) However, the percentage of pain free patients is still quite low. Agents that interact with the GABAergic system seem to have a positive effect in reducing migraine attacks. Divalproex sodium (Depakote) and topiramate (Topamax) are most commonly used and are FDA-approved for migraine prophylaxis. Both drugs have class I evidence supporting their effectiveness in decreasing the frequency of migraine attacks. Other anticonvulsants with weaker evidence for effectiveness include gabapentin, lamotrigine, carbamazepine, and zonisamide. Intravenous antiemetics, with or without intravenous dihydroergotamine, are effective therapies in an emergency department setting. Dexamethasone may be a useful adjunct to standard therapy in preventing short-term headache recurrence. Intranasal lidocaine may also have a role in relief of acute migraine. Isometheptene-containing compounds and intranasal dihydroergotamine are also reasonable therapeutic options. Injections of botulinum toxin (BOTOX®) around the scalp, neck, and shoulders has been approved and is broadly used in the United States for the preventative treatment of chronic migraine. Chronic migraine is defined as 15 or more headache days per month. Surgery has also become a potential therapy for patients suffering from migraines. Surgical release of the greater occipital nerve has been demonstrated to be clinically effective in eliminating or reducing chronic migraine symptoms for some patients, but migraine symptoms persist in others after this procedure.(6) Recent studies of implantable occipital nerve stimulation devices have shown promising but mixed results. Other permanent implants directing electrical stimulation to facial and cranial nerves have been tried as well. Several studies, both retrospective and prospective, have been reported showing migraine frequency and severity relief from implanted vagal nerve stimulators typically used for epilepsy patients. Despite significant advancements in the medical management of this challenging disorder, clinical data have revealed a proportion of patients who do not adequately respond to pharmacologic or surgical intervention and remain symptomatic. Approximately 40% of all attacks do not respond fully to current available therapies.(7)
- 1) http://www.who.int/healthinfo/statistics/bod_migraine.pdf
- 2) IHS. The International Classification of Headache Disorders (2004). Cephalalgia Vol 24. Blackwell/Sage. Retrieved 6/27
- 3) De Felice M., Triptan-induced enhancement of neuronal nitric oxide synthase in trigeminal ganglion dural afferents underlies increased responsiveness to potential migraine triggers. Brain (2010 Aug) 133(Pt 8):2475-88
- 4) Brandes JL, Kudrow D, Stark SR, O’Carroll CP, Adelman JU, O’Donnell FJ, et al. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA. Apr 4 2007;297(13):1443-54.
- 5) Gilmore B, Treatment of acute migraine headache. Am Fam Physician (2011 Feb 1) 83(3):271-80
- 6) Janis JE Neurovascular compression of the greater occipital nerve: implications for migraine headaches. Plast Reconstr Surg (2010 Dec) 126(6):1996-2001
- 7) Edwards KR, Norton J, Behnke M. Comparison of intravenous valproate versus intramuscular dihydroergotamine and metoclopramide for acute treatment of migraine headache. Headache. Nov-Dec 2001;41(10):976-80
Cluster headachePresently electroCore , is marketing the gammaCore device for the acute and prophylactic treatment of cluster headache through specialists in:
Cluster HeadacheCluster headache is a rare type of headache that affects about 1 to 2 people in every 1000. It is called ‘cluster’ headache because headaches typically occur in bouts for 6-12 weeks often at the same time of the year. It is one of the most painful conditions an individual can experience. Cluster headaches are described as excruciating and even more debilitating than migraine. Attacks can last from 15 minutes to three hours and can strike up to eight times a day affecting mostly men at a ratio of about 6:11, often affecting smokers. In the United States, only one product has been approved by the FDA for the treatment of acute cluster headaches and no products have been formally approved for the reduction of the number of cluster attacks. Acute treatment is used to try and stop the pain once it has started which can be difficult as the pain can become very intense very quickly. Cluster headaches are normally treated with a combination of oxygen, various drugs as well as surgically invasive neuro-stimulation. Oxygen presents portability issues, however, while high doses of certain medication are contraindicated or may have unacceptable side effects while any invasive surgery can require the use of anesthetics’ and have a range of possible complications. ElectroCore’s gammaCore has regulatory approval in the European Union, South Africa, India, New Zealand, Australia, Colombia, Canada and Malaysia for the acute and/or prophylactic treatment of cluster headache.
- 1) BASH Guidelines for all Healthcare Professionals in the Diagnosis and management of Migraine, Tension-Type Headache, Cluster Headache, Medication-Overuse-Headache.