This Phase II study was designed to assess the pharmacokinetics, safety and efficacy of MTR-106 tablets in female patients suffering from migraine without aura. The study population consisted of 40 female patients. The average age of participants was 37 +/- 9 years.
The average duration of migraine attacks was 16.6 +/- 10 hours with a frequency of 2.8 +/- 1.3 attacks per month. The subjects were randomized in a ratio of 4:1 treatment to placebo respectively, constituting four groups of 10 patients each. Treatment arms of MTR-106 or placebo were administered at escalating doses of 25, 50, 75 and 100mg.
Analysis of the data showed that at two hours post-treatment significantly more subjects treated with MTR-106 had pain relief compared to those receiving placebo (71% and 25% respectively; p=0.025), and more patients treated with MTR-106 were pain free compared to those receiving placebo (26% and 13% respectively). Of those treated with MTR-106, 23% had sustained pain free at 24 hours post-treatment.
Adrian Harel, CEO of Meditor, said: “We are meeting with the regulatory authorities to further develop and commercialize the drug.”