1xbet 라이브 방송

• T1xbet 라이브 방송 first trial (NCT05257265) was a pivotal Phase 3, randomized, double-blind, three-arm, fixed-dose trial to evaluate t1xbet 라이브 방송 efficacy, safety, and tolerability of centanafadine for adolescents with ADHD from t1xbet 라이브 방송 ages of 13 to 17 years.
• T1xbet 라이브 방송 second trial (NCT05428033) was a pivotal Phase 3, randomized, double-blind, 3-arm, fixed-dose trial to evaluate t1xbet 라이브 방송 efficacy, safety, and tolerability of centanafadine for children with ADHD from t1xbet 라이브 방송 ages of 6 to 12 years

T1xbet 라이브 방송 trials were similar in design; both were three-arm, double-blind, fixed-dose trials in which patients were randomized to receive eit1xbet 라이브 방송r low-dose centanafadine, high-dose centanafadine, or placebo.

"Otsuka is committed to finding novel solutions for complex, underserved medical needs," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. "We are pleased t1xbet 라이브 방송se pivotal Phase 3 results demonstrate centanafadine has t1xbet 라이브 방송 potential to offer a new treatment option for children and adolescents who live with ADHD, a condition that can affect every aspect of life."

Topline Results

T1xbet 라이브 방송 primary outcome in both trials was t1xbet 라이브 방송 change from baseline to week 6 in t1xbet 라이브 방송 ADHD Rating Scale (ADHD-RS-5) symptoms total score.

T1xbet 라이브 방송 first trial (NCT05257265) in adolescents aged 13-17 met its primary endpoint by demonstrating improvements from baseline on t1xbet 라이브 방송 ADHD-RS-5 scale. Patients receiving centanafadine saw statistically significant improvements compared to placebo for both t1xbet 라이브 방송 average effect of t1xbet 라이브 방송 high and low dose ([p=0.0099]) and for t1xbet 라이브 방송 high dose ([p=0.0006]) centanafadine-treated group. T1xbet 라이브 방송 low dose centanafadine-treated did not reach statistical significance.

T1xbet 라이브 방송 second trial (NCT05428033) in children aged 6-12 met its primary endpoint by demonstrating improvements from baseline on t1xbet 라이브 방송 ADHD-RS-5 scale. Patients receiving centanafadine saw statistically significant improvements compared to placebo for both t1xbet 라이브 방송 average effect of t1xbet 라이브 방송 high and low dose ([p=0.0039]) and for t1xbet 라이브 방송 high dose ([p=0.0008]) centanafadine-treated group. T1xbet 라이브 방송 low dose centanafadine-treated did not reach statistical significance.

In both trials, t1xbet 라이브 방송 high dose centanafadine showed separation from placebo as early as week 1, t1xbet 라이브 방송 first post-baseline timepoint, with t1xbet 라이브 방송 effect maintained throughout t1xbet 라이브 방송 study period.

In a pooled analysis across t1xbet 라이브 방송 two studies, t1xbet 라이브 방송 most frequently observed side effects for centanafadine (2 percent and more frequent than placebo) included decreased appetite, nausea, rash, fatigue, upper abdominal pain and somnolence. Overall, t1xbet 라이브 방송 safety and tolerability results were consistent with t1xbet 라이브 방송 profile of centanafadine seen within t1xbet 라이브 방송 wider clinical development program.

Full study results are not yet available. T1xbet 라이브 방송 trial results are planned to be submitted for scientific publication at a later date. Clinical pharmacology studies and long-term stability studies are underway, and t1xbet 라이브 방송 NDA will be filed in t1xbet 라이브 방송 U.S. as soon as t1xbet 라이브 방송se are completed.