Overview of all Migraine Clinical Trials

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:

  1. 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)
  2. 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)
  3. 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.