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July 14, 2014
08:11 EDTADHDAlcobra completes patient recruitment in Phase III clinical trial of MDX
Alcobra announced that recruitment of patients has been completed in the company's Phase III clinical trial of Metadoxine Extended Release, or MDX, in adult ADHD patients. The study is a 300-patient, randomized, placebo-controlled trial conducted at 18 sites in the United States and 2 in Israel. Patients were randomized to receive either 1400 mg MDX or placebo over 6 weeks following a 2-week screening period. The primary endpoint is the Conners' Adult ADHD Rating Scale, or CAARS-INV, a widely accepted clinical measure of the presence and severity of ADHD symptoms. Secondary endpoints include the computerized TOVA, or Test of Variables of Attention, which was also used in the previous Phase 2 studies, as well as safety assessments and additional exploratory endpoints.
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August 19, 2014
08:05 EDTADHDAlcobra announces enrollment of first patient in Phase IIb clinical trial of MDX
Alcobra announced that the first patient has been enrolled in a Phase IIb Fragile X study of MDX. The FDA granted "Orphan Drug" designation to Metadoxine in the treatment of Fragile X Syndrome in December 2013. The Phase IIb Fragile X trial is a multi-center, randomized, placebo-controlled study and is being conducted in 11 clinical sites, primarily in the U.S. It is designed to investigate MDX for 6 weeks compared with placebo in 60 adolescent and adult subjects with Fragile X Syndrome.
August 14, 2014
10:05 EDTADHDSummer Street chief scientific officer holds an analyst/industry conference call
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August 8, 2014
08:56 EDTADHDAlcobra releases results from MRI study to evaluate effects of MDX
Alcobra released topline results from a pharmacological MRI study designed to evaluate the regions of the brain that are modulated by MDX. The study evaluated brain response to a single administration of Metadoxine in rats. The results showed that Metadoxine produced a significant, dose-dependent decrease in BOLD signal in highly selective regions of the brain including the prefrontal cortex and showed a statistically significant increase in BOLD response in brain regions including the central nucleus of the amygdala and the lateral hypothalamus. In addition, none of the mesolimbic dopamine system brain regions , known to be involved in the reinforcing effects of scheduled drugs, were significantly affected by Metadoxine at any dose level, which is consistent with previously presented data.

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