FDA Grants $1M to Test Memantine in ALS

The US Food and Drug Administration (FDA) just awarded $14 million in funding to support efforts to develop therapeutics for 15 rare diseases. One of the awardees was Dr. Todd Levine from the PNA Center for Neurological Research in Phoenix, Arizona. Dr. Levine was awarded $990,000 distributed over the course of three years to support his Phase IIb clinical trial of memantine, an N-methyl-D-aspartate (NMDA) receptor antagonist with the potential to block glutamate mediated excitotoxicity (currently on the market for Alzheimer’s Disease), for the treatment of ALS. Memantine has had a long history of being tested in ALS. In 2005 a group from The Burnham Institute in La Jolla, California reported a 7% increase in survival in memantine treated SOD1 mice. In 2010, a group at the Institute of Molecular Medicine at the University of Lisbon in Lisbon, Portugal reported their results of a Phase II/III study of memantine. The study found memantine to be safe and well-tolerated in people living with ALS. Unfortunately, the researchers were unable to comment about the effect of memantine on survival. Another Phase II study sponsored by the University of Alberta in Canada examined the effect of memantine on functional outcomes (no outcome reported). Finally, a third Phase II study (run by Dr. Levine himself) tested both the tolerability and safety of memantine in ALS. The study also looked to see if drug treatment could be correlated to changes in a CSF biomarker. Unfortunately, because the study was open label, no conclusion could be made regarding the efficacy of the drug. Although many clinical studies have been conducted, we still don’t have a clear answer about the efficacy of memantine in ALS. Let’s hope Dr. Levine’s next study will be appropriately powered (and blinded) so that we can finally have an answer to this unsolved question.

The US Food and Drug Administration (FDA) just awarded $14 million in funding to support efforts to develop therapeutics for 15 rare diseases. One of the awardees was Dr. Todd Levine from the PNA Center for Neurological Research in Phoenix, Arizona. Dr. Levine was awarded $990,000 distributed over the course of three years to support his Phase IIb clinical trial of memantine, an N-methyl-D-aspartate (NMDA) receptor antagonist with the potential to block glutamate mediated excitotoxicity (currently on the market for Alzheimer’s Disease), for the treatment of ALS. Memantine has had a long history of being tested in ALS. In 2005 a group from The Burnham Institute in La Jolla, California reported a 7% increase in survival in memantine treated SOD1 mice. In 2010, a group at the Institute of Molecular Medicine at the University of Lisbon in Lisbon, Portugal reported their results of a Phase II/III study of memantine. The study found memantine to be safe and well-tolerated in people living with ALS. Unfortunately, the researchers were unable to comment about the effect of memantine on survival. Another Phase II study sponsored by the University of Alberta in Canada examined the effect of memantine on functional outcomes (no outcome reported). Finally, a third Phase II study (run by Dr. Levine himself) tested both the tolerability and safety of memantine in ALS. The study also looked to see if drug treatment could be correlated to changes in a CSF biomarker. Unfortunately, because the study was open label, no conclusion could be made regarding the efficacy of the drug. Although many clinical studies have been conducted, we still don’t have a clear answer about the efficacy of memantine in ALS. Let’s hope Dr. Levine’s next study will be appropriately powered (and blinded) so that we can finally have an answer to this unsolved question.

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