Date: 2015-03-10
Type of information: Results
phase: 2b
Announcement: results
Company: Alcobra (Israel)
Product: Metadoxine Extended Release (MDX), previously known as MG01CI (pyridoxol L-2-pyrrolidone-5-carboxylate)
Action
mechanism: MDX (Metadoxine Extended Release (MG01CI)) is a proprietary investigational new drug candidate being developed by Alcobra for the potential treatment of ADHD and Fragile X Syndrome. MDX is not a stimulant and acts as a monoamine-independent modulator of GABA (gamma-aminobutyric acid) transmission. This novel mechanism of action does not directly affect dopamine or norepinephrine. In studies to date, metadoxine has shown no potential for abuse or addiction. MDX is currently in Phase III development for adults with ADHD and Phase II development for pediatric ADHD. A study of MDX is also ongoing in adolescents and adults with Fragile X Syndrome.
Disease: Attention Deficit Hyperactivity Disorder (ADHD)
Therapeutic area: CNS diseases - Mental diseases - Neurological diseases
Country: israel
Trial
details: The purpose of this study is to evaluate the safety and tolerability of a single administration of Metadoxine Extended Release (MDX) formulation for the treatment of adolescents diagnosed with ADHD that have predominantly inattentive symptoms. The study will also try to evaluate the efficacy of MDX and its level in the blood. (NCT02189772)
Latest
news: * On March 10, 2015, Alcobra, 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 that its Phase II safety and tolerability study of a single administration of MDX in adolescent patients with ADHD achieved its primary endpoint. In the study, MDX showed good tolerability and no safety concerns were identified. The profile of adverse events in the MDX treated group was not different from the placebo comparator group. There were no reported cases of discontinuation from the study due to adverse events. A total of 83 patients enrolled in the Phase II trial, which was a multi-center, randomized, double-blind, placebo controlled, fixed dose study designed to evaluate the safety and tolerability of a single administration of MDX in adolescents (aged 13-17) with predominantly inattentive ADHD. Following a screening period, patients were exposed to either placebo or one of three MDX dose options determined by their weight and followed for several hours that day. Patients returned several days after this treatment visit for a safety follow-up visit. Patients' baseline characteristics were similar between MDX and placebo groups. The most common side effects were headache (8% of patients in the MDX group and 12% in the placebo group), nausea (3% vs. 5%) and fatigue (3% vs. 5%). No clinically significant safety findings in laboratory values, vital sign measurements, ECG parameters, cardiovascular parameters or findings during clinical examination were observed. Analyses of secondary cognitive measures, after a single administration of MDX compared to placebo, did not produce statistically significant findings, yet resulted in an efficacy signal on the Test of Variables of Attention (TOVA) assessments Response Time and Errors of Omission. A separate study evaluating MDX in adolescents and adults with Fragile X Syndrome is currently underway and actively enrolling patients. Results of the Fragile X Study are expected to be reported by the end of 2Q15. The Phase IIb trial is a multi-center, randomized, double-blind, fixed dose study designed to evaluate the safety and tolerability of MDX in up to 82 adolescents (aged 13-17) with predominantly inattentive ADHD (PI-ADHD). The primary endpoint will be safety, tolerability and pharmacokinetics. Secondary endpoints include change in efficacy measures such as TOVA (Test of Variables of Attention), Wechsler Intelligence Scale for Children (WISC-IV) subtests, and working memory and processing speed.
* On September 2, 2014, Alcobra, 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 that the first patient has been enrolled in a Phase IIb study of MDX in adolescents with ADHD. The trial is expected to complete enrollment and report topline data by the end of 2014.
