Researchers from the Jefferson Headache Center have completed a multi-center, phase 3 clinical trial demonstrating that Levadex, an orally-inhaled migraine therapy, provides “significant relief” from migraine symptoms.
Researchers from the Jefferson Headache Center at Thomas Jefferson University Hospital have completed a multi-center, phase 3 clinical trial demonstrating that Levadex, an orally-inhaled migraine therapy, provides “significant relief” from migraine symptoms.
During the course of the FREEDOM-301 trial, patients with moderate or severe migraine attacks who received Levadex experienced pain relief within 30 minutes of taking the drug, relief that was sustained for 48 hours after the initial dose. Levadex also provided nausea relief and light and sound sensitivity compared to placebo treatments.
The phase 3 trial was “designed to evaluate the safety and efficacy of Levadex as a potential treatment for acute migraine,” according to the researchers. Primary efficacy measures of the trial were pain relief and freedom from phonophobia, photophobia, and nausea within two hours of taking the drug. Patients who participated in this segment of the trial “were evaluated for the treatment of a single moderate or severe migraine attack and then were given the option to continue in an open label, long-term safety study.” The trial “is targeting 300 patients for six months and 150 patients for 12 months” and includes over 500 patients who “are continuing in this arm of the trial.”
According to the researchers, Levadex is designed “to be differentiated from existing migraine treatments.” Results of the ongoing study have thus far shown that the drug “has the potential to provide both fast onset of action and sustained pain relief and other migraine symptom relief in an easy-to-use and non-invasive at-home therapy.” In addition, Levadex has not had some of the side affects that are often seen as a result of other common migraine medications.
“The major advantage of LEVADEX is that it has the efficacy of intravenous DHE (dihydroergotamine) with a side-effect profile similar to placebo and better than oral triptans,” said Stephen Silberstein, MD, FACP, a clinical study investigator, director of the Jefferson Headache Center, and professor in the Department of Neurology at Jefferson Medical College.