–Last patient visit scheduled for November 26, 2013
–Data expected to be announced during the week of December 16, 2013
TEL AVIV, Israel I November 5, 2013 I Alcobra Ltd. (ADHD), an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug candidate, MG01CI (Metadoxine extended-release), to treat cognitive dysfunctions, such as ADHD and Fragile X Syndrome, announced today that it has successfully enrolled the 36th and final patient in a placebo-controlled Phase II clinical study designed to compare the efficacy of varied dosage levels of MG01CI to treat and improve cognitive dysfunctions in adult subjects with Predominantly Inattentive Attention Deficit/Hyperactivity Disorder (PI-ADHD). The last patient visit is scheduled for November 26, 2013 and the data is expected to be announced during the week of December 16, 2013.
“This study is an important extension of our efforts to better understand the clinical benefits of MG01CI beyond treating patients exhibiting core ADHD clinical symptoms,” commented Dr. Yaron Daniely, President and Chief Executive Officer of Alcobra Ltd. “In addition to ADHD, our goal is to take advantage of the favorable safety and efficacy profile of MG01CI to potentially treat other major cognitive disorders such as Fragile X Syndrome.”
The data from the study is expected to confirm and consolidate previous observations about MG01CI, including: the significant effect size seen in PI-ADHD patients; the benefits on executive functions (beyond core deficits of ADHD) such as spatial and working memory, visual information processing, reaction time and inhibitory control; and the rapid onset of the drug (as compared to other non-stimulants ADHD drugs that take several weeks).
The study is evaluating 700mg and 1,400mg doses, which were found to be most effective in previous Alcobra studies.
The study is registered on ClinicalTrials.gov, number NCT01685281.
About Alcobra Ltd.
Alcobra Ltd. is an emerging biopharmaceutical company primarily focused on the development and commercialization of a proprietary drug candidate, MG01CI, to treat cognitive dysfunctions including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome. MG01CI has completed Phase II studies to treat ADHD. The Company was founded in 2008 and is headquartered in Tel Aviv, Israel. For more information please visit the Company’s website, www.alcobra-pharma.com, the content of which is not incorporated herein by reference.
SOURCE: Alcobra
Post Views: 429
–Last patient visit scheduled for November 26, 2013
–Data expected to be announced during the week of December 16, 2013
TEL AVIV, Israel I November 5, 2013 I Alcobra Ltd. (ADHD), an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug candidate, MG01CI (Metadoxine extended-release), to treat cognitive dysfunctions, such as ADHD and Fragile X Syndrome, announced today that it has successfully enrolled the 36th and final patient in a placebo-controlled Phase II clinical study designed to compare the efficacy of varied dosage levels of MG01CI to treat and improve cognitive dysfunctions in adult subjects with Predominantly Inattentive Attention Deficit/Hyperactivity Disorder (PI-ADHD). The last patient visit is scheduled for November 26, 2013 and the data is expected to be announced during the week of December 16, 2013.
“This study is an important extension of our efforts to better understand the clinical benefits of MG01CI beyond treating patients exhibiting core ADHD clinical symptoms,” commented Dr. Yaron Daniely, President and Chief Executive Officer of Alcobra Ltd. “In addition to ADHD, our goal is to take advantage of the favorable safety and efficacy profile of MG01CI to potentially treat other major cognitive disorders such as Fragile X Syndrome.”
The data from the study is expected to confirm and consolidate previous observations about MG01CI, including: the significant effect size seen in PI-ADHD patients; the benefits on executive functions (beyond core deficits of ADHD) such as spatial and working memory, visual information processing, reaction time and inhibitory control; and the rapid onset of the drug (as compared to other non-stimulants ADHD drugs that take several weeks).
The study is evaluating 700mg and 1,400mg doses, which were found to be most effective in previous Alcobra studies.
The study is registered on ClinicalTrials.gov, number NCT01685281.
About Alcobra Ltd.
Alcobra Ltd. is an emerging biopharmaceutical company primarily focused on the development and commercialization of a proprietary drug candidate, MG01CI, to treat cognitive dysfunctions including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome. MG01CI has completed Phase II studies to treat ADHD. The Company was founded in 2008 and is headquartered in Tel Aviv, Israel. For more information please visit the Company’s website, www.alcobra-pharma.com, the content of which is not incorporated herein by reference.
SOURCE: Alcobra
Post Views: 429
