Single Center, Phase 2B, Randomized, Double-Blind, Placebo, Individual Components, and 2-Dose Comparator-Controlled Study to Assess the Efficacy and Safety of a Single Dose of Oral ALLOD-2 in the Acute Treatment of Moderate-to-Severe Migraine (ANODYNE-1) The estimated Study Completion is February 2018.
Single Center, Phase 2B, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of a Single Dose of Oral ALLOD-2 Versus Oral Sumatriptan in the Acute Treatment of Migraine With Associated Nausea in Adults (ANODYNE-2)
About the Investigational Product
The investigational product (ALLOD-2), is a combination of two re-purposed marketed drugs used for the treatment of migraines due to discovery of biologically and clinically relevant affinity for new targets. Both drugs are being re-purposed at a significantly lower dosage compared to the maximum dose that has already been approved for the marketed indications.
The combination is a First-in-Class drug due to its new and unique mechanism of action.
The investigation will focus on the comparison of migraine-associated nausea, which has been shown none-responsive to any of the other known migraine treatments and is considered an unmet treatment need.
ALLOD-2 reverses neuroinflammation through dual action, inhibition of the release of pro-inflammatory cytokines and inhibition of the COX-2 activation. Efficacy of this product for migraine headache pain and for migraine-associated symptoms, especially nausea, may suggest the product addresses the root cause of migraines.