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Alcobra Ltd. (ADHD) Expects Topline MDX Phase III Clinical Trial Data in Two Weeks
September 19, 2014 4:35 PM EDT
Alcobra Ltd. (Nasdaq: ADHD), an emerging pharmaceutical company focused on the development of new medications to help patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, announced today that all scheduled follow-up visits have been completed for patients enrolled in the company's Phase III clinical trial of Metadoxine Extended Release (MDX) in adult ADHD patients.
"Completion of this Phase III clinical trial is a major milestone in the development of MDX, as we are one step closer to a potential new treatment alternative for Adult ADHD," said Dr. Yaron Daniely, President and Chief Executive Officer of Alcobra. "We currently anticipate completing data verification in this multi-center trial, database lock and topline statistical analysis in approximately two weeks. We look forward to unblinding the data and announcing the results."
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 followed by a 2-week safety follow-up and preceded by a 2-week screening period. The primary endpoint measure is the Conners' Adult ADHD Rating Scale (CAARS-INV), a widely accepted clinical measure of the presence and severity of ADHD symptoms, and the same endpoint utilized in the company's successful Phase IIb study. Secondary endpoints include the computerized TOVA (Test of Variables of Attention), which was also used in the previous Phase II studies, as well as safety assessments and additional exploratory endpoints.
http://www.streetinsider.com/Corporate+News/Alcobra+Ltd.+(ADHD)+Expects+Topline+MDX+Phase+III+Clinical+Trial+Data+in+Two+Weeks/9847867.html
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Alcobra Ltd. (ADHD) Expects Topline MDX Phase III Clinical Trial Data in Two Weeks
September 19, 2014 4:35 PM EDT
Alcobra Ltd. (Nasdaq: ADHD), an emerging pharmaceutical company focused on the development of new medications to help patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, announced today that all scheduled follow-up visits have been completed for patients enrolled in the company's Phase III clinical trial of Metadoxine Extended Release (MDX) in adult ADHD patients.
"Completion of this Phase III clinical trial is a major milestone in the development of MDX, as we are one step closer to a potential new treatment alternative for Adult ADHD," said Dr. Yaron Daniely, President and Chief Executive Officer of Alcobra. "We currently anticipate completing data verification in this multi-center trial, database lock and topline statistical analysis in approximately two weeks. We look forward to unblinding the data and announcing the results."
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 followed by a 2-week safety follow-up and preceded by a 2-week screening period. The primary endpoint measure is the Conners' Adult ADHD Rating Scale (CAARS-INV), a widely accepted clinical measure of the presence and severity of ADHD symptoms, and the same endpoint utilized in the company's successful Phase IIb study. Secondary endpoints include the computerized TOVA (Test of Variables of Attention), which was also used in the previous Phase II studies, as well as safety assessments and additional exploratory endpoints.
http://www.streetinsider.com/Corporate+News/Alcobra+Ltd.+(ADHD)+Expects+Topline+MDX+Phase+III+Clinical+Trial+Data+in+Two+Weeks/9847867.html
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