Clinical Trials Resource Center


August 16, 2010

Trigemina reported positive results from a phase IIa trial TI-001 (intranasal oxytocin) for the treatment of chronic daily headache. This double blind placebo controlled trial enrolled 40 subjects who were suffering from at least 15 days of headache pain per month. All subjects were refractory to available medications. Based on numeric pain scales, 50% of the TI-001 treated arm reported at least a 50% reduction in pain at four hours compared to 11% of the placebo treated arm. In addition, 27% of the TI-001 treated arm reported zero pain at four hours versus none of the placebo treated arm. Secondary symptoms including nausea, photophobia, and phonophobia were also improved in the TI-001 group compared to the placebo group.

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