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Houston Headache Clinic conducting phase III trial of Botox for its efficacy to treat migraine
Vivek Narayanan, Chennai | Friday, January 12, 2007, 08:00 Hrs  [IST]

Houston Headache Clinic in the US, an exclusive centre for the treatment of headaches especially chronic migraines, is conducting the phase III trials on the efficacy of two drugs for acute and chronic migraine headache. Various pharmaceutical companies have sponsored the research.

The pharmaceutical companies after finishing the phase 1 trials have approached the Houston Headache Clinic for conducting the second and third phase trials. The drugs that are being tested are Botox, the brand name of botulinum toxin type A, manufactured and marketed by Allergan Inc, Topamax and CGRP antagonists.

While Botox and CGRP has completed the phase II trials successfully and is on the phase III trials, Topomax has already hit the market. Speaking on Botox that was used for therapeutic and cosmetic purposes and has now ventured into the treatment of headaches, Dr Ninan T Mathew, director, Houston Headache Clinic, said, "Botox was primarily used for various neurological disorders. But, now the efficacy of the drug for treating headaches is being tested. We have conducted the trial on nearly 360 people and various other studies were done by other centres."

Patients are injected with Botox in muscles of the eye area, nose area, forehead, sides of the head, and neck every three to four months. Botox has been shown to reduce the need for multiple preventive medications. All these have been revealing suggestions that Botox is a treatment worth going for to get relieved both from the pain and the muscle contraction.

"All the preventive medicines have to be taken on a daily basis like that for blood pressure and similar illness. But on the long run they may have side effects like weight gain and fatigue. But, Botox if injected once the pain is alleviated for nearly 4 to 5 months. Then again when the pain reappears, the medicine has to be injected again," said Dr Ninan.

The advantage of Botox is that it is focal and temporary in action. It works only in the muscle where it is injected and thus, does not have any systemic side effects. Like many medication, the effect of the medicine on the affected area and is not permanent. The effect lasts anywhere from 3 to 18 months. Hence it is imperative for people to get the treatment every time the effect ceases. This is true for both therapeutic and cosmetic treatments.

Commenting on the percentage of people affected with migraine in India, he said that around 18 per cent of women and 6 per cent of men were affected and out of which 4 per cent had chronic migraines. "The prevalence of headaches is more in women as there is some connection with their hormones. That is the reason why they tend to get headaches more often than men, "he said.

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