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MIGRAINE EXPERT DR MARKKU NISSILÄ has managed over 100 clinical trials for migraine, testing treatments from new triptans to the latest CGRP antibodies. Why does Menstrual Migraine remain so resistant to standard treatments, and why are more and more migraine researchers turning towards the science of reproductive hormones?
“Standard prophylactic treatments have no efficacy in Menstrual Migraine” says Dr Markku Nissilä “There is a huge unmet need for a specific, efficacious treatment for this type of migraine.”

Dr Nissilä is Asarina Pharma’s National Country Coordinator for Finland for the Phase IIa trial of Sepranolone for Menstrual Migraine (MM), launched in July 2019 and scheduled to run until 2020.

“For every one man, three women endure migraine” says Nissilä “60% of all female migraineurs suffer from Menstrual Migraine. As Menstrual Migraine remains the most consistently resistant to current treatments, interest in the specific neuro-hormonal mechanisms that trigger this form of migraine is high”.

In a 20 July 2019 interview, CGRP scientist Professor Lars Edvinsson (Lund University), highlighted reproductive hormones as a key area for his own future research, telling Sweden’s Dagens Nyheter newspaper “many women have migraine attacks when they get their period, connected to marked changes in oestrogen and progesterone. In my ongoing research, I want to understand the connection between various hormones and migraines.”

Dr Nissilä managed trials of CGRP antibodies—the most recent new range of migraine treatments—throughout Finland. He was national coordinating investigator for Erenumab and Fremanezumab and conducted trials of CGRP products Galcanezumab.

“My experience was that Menstrual Migraine attacks were the only kind to keep persisting throughout CGRP medication. Neither triptans nor CGRP antibodies are fully effective against Menstrual Migraine yet”.
Migraine specialist Dr Markku Nissilä
“This is the most highly targeted MM Study I have ever been part of. Sepranolone is the most highly targeted prophylactic treatment for MM I’ve seen. I’m confident this is something worth looking into in more detail.”
Migraine specialist Dr Markku Nissilä

Dr Markku Nissilä

Highly targeted TRIAL & treatment

For Dr Nissilä the fact that Sepranolone is such a highly specific treatment is crucial.

With the intensity and frequency of Menstrual Migraine attacks concentrated directly prior to and during menstruation, when concentration of the neurosteroid Allopregnanolone is dropping rapidly, attacks could well be in direct response to this, with Sepranolone, the body’s endogenous regulator of Allopregnanolone, effectively treating this withdrawal—and so the Menstrual Migraine attacks. “When I first read the protocol I was excited” he says “it was like finding the final piece of a puzzle. I realized that this could be the mechanism that triggers Menstrual Migraine, and what makes it so resistant to other treatments.

With over 100 clinical trials in migraine under his belt, as co-founder of one of Northern Europe’s largest medical centres devoted to headache, and as Director of Terveystalo Clinical Research and Biobank, Finland’s largest headache and migraine database, Dr Nissilä is confident that enrolment will go smoothly.

“We have a huge headache database here in Finland, started in 2014, with close to 1 million consented patients overall and tens of thousands of women suffering specifically from Menstrual Migraine. The protocol for the study is extremely clear and the science highly promising. I’ll be excited to see the results when they become available. With 50 million women worldwide living with Menstrual Migraine the demand for this kind of trial and this mode of action is huge.”