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Botulinum Toxin Treatment BOTOX Chronic Migraine Study

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Overview of the Botox Treatment for Migraine

Botox® (onabotulinum toxin A) has many uses in the fields of cosmetic, dentistry and medicine. In general medicine there are many conditions which are licensed for treatments with BOTOX® and other brands of neurotoxin. In this article we will specifically review the treatment of chronic migraine.

In July 2010 the Medicines and Healthcare products Regulatory Agency (MHRA) licensed the use of the Botox® for the treatment of chronic migraine in adults.

What is botulinum toxin?

You may have heard the word Botox® referred to many times in cosmetic medicine. However Botulinum toxin also has many uses in therapeutic medicine. These include treatments for dystonia (including writers cramp), post-stroke spasticity, hyperhidrosis and chronic migraine.

Other botulinum toxin preparations are available, both of type A and B. The Dysport® and Xeomin® are also type A the same type as Botox®.  Type B toxins include Neurobloc® and Myobloc®. These brands are not currently licensed for any headache disorders (2017). Some of these products may be submitted and licensed for conditions in the future, therefore you should review the current SPC document for each product to find the up to date information regarding their licensing and uses.

The discovery of the botulinum toxin treatment for headaches

During the 1990s it was reported by a number of individuals that they had an improvement with their headaches when receiving botulinum toxin for other reasons. This launched the clinical trials with botulinum toxin for various types of headache followed. The analysis of the results of the clinical study suggested that only a subgroup of patients with chronic migraine who could benefit, so further trials focused on the chronic migraine were started.

Botox® chronic migraine clinical trials study overview

The study Evaluating Migraine Prophylaxis Therapy (PREEMPT) trials recruited 1384 patients with chronic migraine, and randomised them to treatment with the Botox® brand or placebo.

Study overview: Patient Criteria

  • The patients were suffering on average 20 days of headache each month
  • At least 18 headaches during the period were moderate or severe

Study overview: Patient Treatments

  • The Botox® patients received fixed-site, fixed dose injections every 12 weeks over 56 weeks
  • These injections covered seven specific areas of the head and neck (A to G Fig 1)
  • A total dose of between 155-195 units

Botox Chronic Migraine Treatment Injection 1 Botox Chronic Migraine Treatment Injection 2 Botox Headache Cronic Migraine Injection 3

Fig 1(Courtesy Allergan Inc.)

Study overview: Treatments Outcomes

At six months, after two cycles of treatment, those treated with Botox® had on average eight less days of headache each month. After 12 months, 70% of those treated had <_50% the number of headaches that they had done originally.

Study overview: Treatment Adverse Events

Botox® was well-tolerated, the commonest side effects being neck pain (6.7%), muscular weakness (5.5%), and drooping of the eyelid (3.3%). No serious irreversible side effects were reported during the trials with Botox® for headaches.

How to identify if Botox® is the right treatment for the patients headache

Only patients with chronic migraines are eligible for this type of treatment with Botox®. Chronic migraine is a headache that happens on 15 or more days each month, at least half of which have the symptoms of a chronic migraine. Patients who suffer from other types of headaches are not currently eligible for this treatment (2017).

Who can inject Botox® for chronic migraine?

At present the use of Botox® is restricted to a few specialist headache centres, but as time goes on there should be increasing numbers of trained injectors available. In all cases, however, you should ensure that the person injecting has received appropriate training, both in the diagnosis and management of chronic migraine, and in the delivery of Botox® according to the proven PREEMPT schedule.

Availability of Botox® for treating chronic migraine on the NHS

The National Institute for Health and Care Excellence (NICE) have issued guidance about Botox® on the NHS as a preventive treatment option for adult patients with chronic migraine. This applies to NHS settings in England and Wales. Guidance also now exists for NHS Scotland.

If you suffer from chronic migraine and you would like this botox treatment during one of our courses visit the KT Training cosmetic treatment models web site to register your interest.

References: Allergan BOTOX® for Chronic Migraine Clinical Study, BOTOX® SPC-Allergan Inc.

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