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NeuroSearch, the drug company that is sponsoring ACR-16 announced progress on clinical trials for this drug in the U.S. This means that the FDA has accepted phase II clinical trial results from Europe, and given the go-ahead for proceeding directly to phase III in the U.S. If this drug is as good as first studies suggest, foregoing another phase II trial in the U.S. will save years of time getting this drug to people.
Trial Description: Large trials for Huntington's are planned for both the U.S. and Europe with the assistance of the Huntington Study Group (HSG) and the European Huntington's Disease Association (EHDA). Trials will be randomized, double-blinded, and placebo-controlled, testing the drug for six months. Motor function, behavior, depressive symptoms, anxiety and cognitive functions will be studied.
The Drug: ACR-16 is a dopamine stabilizer. It works to "smooth" the many functions of this neurotransmitter chemical in striatum and other areas of the brain. ACR-16 is also being studied in other psychiatric and neurologic diseases.
The Story behind the Drug: Decades of research took place in the labs of Dr. Arvid Carlsson from Sweden that led to to the development of this drug (and his Nobel prize). The first drug of this type, OSU6162 was tried in 1999 on a single Huntington's patient. The results were dramatic. A single dose given intravenously decreased chorea events from almost 40 events/minute to fewer than 2 events per minute [Tedroff 1999]. For the next 10 days the patient was able to independently drink and feed herself without spilling, things she had not been able to do for the previous 2 years. Per communication to SET-HD, Dr Carlsson believes ACR-16 will be better.
If this drug turns out to be as good as suggested, consideration should be given to early access programs for those who do not qualify for clinical trials. This was done for Parkinson's disease when L-dopa was introduced. Why not for Huntington's and ACR-16?
Tedroff J, Ekesbo A, Sonesson C, Waters N, Carlsson A. Long-lasting improvement following (-)-OSU6162 in a patient with Huntington's disease. Neurology 1999 Oct 22;53(7):1605-6. PubMed abstract
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