Date: 2011-09-07
Type of information: Results
phase: 2
Announcement: results
Company: Teva Pharmaceutical Industries (Israel) Alcobra (Israel)
Product: MG01CI (extended release formulation of Metadoxine (pyridoxol L-2-pyrrolidone-5-carboxylate)
Action mechanism:
Disease: attention deficit hyperactivity disorder (ADHD)
Therapeutic area: CNS diseases - Neurological diseases
Country: Israel
Trial
details: One hundred and twenty subjects in two Israeli centers (Geha MHC and Rambam), enrolled into the randomized, double-blind, placebo-controlled, parallel-group study in adult subjects with ADHD. Eligible subjects were randomly assigned in a 1:1 ratio to one of two treatment groups, 1400 mg MG01CI and Placebo. Patients enrolled in the study displayed similar demographic and ADHD symptoms characteristics as previously published studies, and randomization yielded comparable subject groups. The study consisted of three periods: a screening period of up to two weeks, a six-week double-blind treatment period, and a two-week safety follow-up period. Subjects were evaluated at baseline, and again following one, two, four and six weeks using validated, standard evaluation tools such as the CAARS-INV scale, the AAQoL scale, the Clinical Global Impression (CGI) scale, and the T.O.V.A.® test. Safety evaluations included adverse events and concomitant medication recording, routine laboratory assessments, vital signs, physical and neurological exams, the Columbia-Suicide Severity Rating Scale (C-SSRS) and 12-lead electrocardiogram (ECG) measures.
Latest
news: Teva Pharmaceutical Industries Ltd. and Alcobra Ltd. Have announced top-line results from a six week, randomized, placebo-controlled, Phase II multi-center study designed to assess the safety and efficacy of MG01CI in adults with attention deficit hyperactivity disorder (ADHD). Results showed MG01CI met the primary efficacy outcome, demonstrating a significant improvement on the Conners\'Adult ADHD Rating Scale-Investigator Rated Total ADHD Symptoms Score (CAARS-INV) compared to placebo (p<0.03). In the study, 56 percent of subjects treated with MG01CI experienced an improvement in their CAARS-INV score of at least 25 percent, compared to 36 percent of patients in the placebo group (p<0.03). Additionally, 44 percent of the subjects treated with MG01CI demonstrated an improvement of more than 40 percent in their CAARS-INV score versus only 25 percent in the placebo group (p<0.04). MG01CI was well tolerated, with no drug-related serious adverse events reported and no clinically or statistically significant differences in adverse event profiles between the MG01CI and placebo treatment arms. Nausea and initial insomnia were more frequently reported in the MG01CI arm, yet the rate of patient discontinuation due to adverse events was similar in both groups (1.7%). Importantly, no increase in blood pressure or appetite suppression was recorded in the treatment group.
