Positive Results Announced From Migraine With Aura Trial
Minster Pharmaceuticals plc (AIM: MPM), the drug development company specializing in neurological and psychiatric disorders, is pleased to announce positive results from its Phase II trial in Denmark of tonabersat in the prevention of migraine with aura. The median number of aura attacks was reduced by 68% (p=0.01) in patients receiving tonabersat when compared with placebo. This result in the primary endpoint of the study is both clinically and statistically highly significant.
A further primary endpoint showed a reduction in the number of migraine headache days. This reduction did not reach statistical significance, probably owing to the small number of patients participating in the trial and, it is thought, because some of the patients suffered a type of migraine aura that is not followed by headache.
The results also showed statistically significant effects on some of the secondary endpoints including the number of attacks of migraine headache and the number of auras followed by any headache. All secondary endpoints were numerically in favor of tonabersat compared with placebo.
Migraine with aura affects around 30 percent of migraine sufferers and is a type of migraine in which the headache is preceded by symptoms such as visual disturbances and abnormalities of speech and hearing. These aura symptoms are generally recognized as being difficult to treat with existing medications.
A total of 31 patients completed the Phase II trial, which was conducted at the Danish Headache Center at Copenhagen's Glostrup University Hospital. The principal investigator in the trial was Professor Jes Olesen, the Danish Headache Center's Director and one of the world's leading authorities on headache.
Under the trial's cross-over design, patients took either tonabersat or placebo once a day for a three-month period after which the treatment regimen was reversed such that those initially on tonabersat received placebo and vice versa. The tonabersat dosage was 20mg a day for the first two weeks, increasing to 40mg a day for the subsequent 10 weeks.
In line with previous experience, tonabersat was generally well tolerated by patients.
It is expected that the detailed results of the trial will be published by Professor Olesen's group in a peer-reviewed article in a leading international journal.
Tonabersat is the leading compound in an exciting new class of selective drugs known as neuronal gap junction blockers, which offer the potential to prevent the onset of migraine as a preferred alternative to acute treatment.
Minster is currently conducting the 500 patient TEMPUS trial of tonabersat in prevention of migraine in the US and Canada. This Phase IIb trial is fully enrolled and results are expected in the first quarter of 2009.
"This is the first time for more than 30 years that a drug designed specifically for migraine prevention shows significant efficacy. There is a huge need for better preventives, so these trial results are very encouraging. It is clear that tonabersat has very real potential in the preventive treatment of migraine," said Professor Jes Olesen, the principal investigator in the trial and Director of the Danish Headache Center.
"The very positive results from this Phase II trial in migraine with aura reinforce our confidence in the potential of tonabersat. These results represent a significant advance in our overall program, which we are well funded to deliver, to establish tonabersat as the treatment of choice for prevention of migraine attacks. We look forward to the results of the TEMPUS trial of tonabersat in the wider migraine population, which is on track to report out in Q1 2009," said Paul Sharpe, Minster Pharmaceuticals' Chief Executive Officer.