As of February, 2017, Dr. Annette Toledano has been recruiting patients for two acute migraine clinical trials and one migraine prevention clinical trial out of her North Miami office. The office is located at: 1785 NE 123rd Street, North Miami, 33181, Telephone: 305-895-6808.
For more information please the visit clinicaltrials.gov:
- 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)
- 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)
- A Single Center, Phase 2B, Randomized, Double Blind, Study to Assess the Efficacy, Safety, and Tolerability of ALLOD-2 vs. Placebo in the Prevention of Episodic Migraine in Adults (ANODYNE-3)
The investigational product (ALLOD-2), is a combination of two re-purposed marketed drugs used for the treatment of migraine due to discovery of biologically and clinically relevant affinity for new targets. Both drug 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 its new and unique mechanism of action.
The investigation will focus on 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 migraine.