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news.Minster Pharmaceuticals, a drug development company, has announced positive results from its Phase II trial in Denmark of tonabersat in the prevention of migraine with aura.
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According to the company, 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. In line with previous experience, tonabersat was generally well tolerated by patients, the company said.
A total of 31 patients completed the Phase II trial, which was conducted at the Danish Headache Center at Copenhagen’s Glostrup University Hospital. 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.
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.
Paul Sharpe, CEO of Minster Pharmaceuticals, said: “The very positive results from this Phase II trial in migraine with aura reinforce our confidence in the potential of tonabersat. 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 the first quarter of 2009.”