Study 204 was a randomised, double-blind, placebo-controlled, two arm study of a single oral dose of 600 mg of NXN-188 for the treatment of moderate to severe acute migraine headache without aura. In the trial, 86 patients received NXN-188 and 88 patients received placebo.
In the trial, NXN-188 demonstrated efficacy compared to placebo on the additional key measures of pain freedom, sustained pain freedom, and use of rescue medication.
Rescue medication is frequently required with current migraine treatments, but in this study the use of rescue medication following NXN-188 was nearly half that for placebo.
The primary endpoint was pain relief at 2 hours: although NXN-188 did not reach significance at this time point, a statistically prominent response was reported from 4 through 24 hours.
NeurAxon chief medical officer Robert Medve said that they have evaluated total migraine freedom, the complete absence of all pain, nausea, and sensitivity to light and sound, and found that a significant proportion of patients receiving NXN-188 reported that all of their migraine symptoms had abated.
"NXN-188 shows benefits across multiple measures and multiple time points as early as 30 minutes after dosing, and we believe that it has the potential to make a meaningful difference in patients’ lives," Medve said.