Phase II Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder -Long term Extension Study
Phase 2
Completed
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Registration Number
- JPRN-jRCT2080222082
- Lead Sponsor
- SHIONOGI & CO., LTD.
- Brief Summary
There is no major safety concerns in Japanese pediatric patients with ADHD who received S-877489 30-70mg for 53weeks. The changes in ADHD-RS-IV total score at LOCF and all points from 1 to 53 weeks indicated a significant decrease from baseline. The other endpoints (ADHD-RS-IV subscale score, Conners 3 symptom scale score and the total score, CGI-I, CGI-S, PGA, QCD) also showed improvement at the final evaluation point, suggesting the long-term sustainable efficacy of S-877489.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Patients who hope to continue treatment with S-877489 after the preceding study. etc.
Exclusion Criteria
Patients who have complications such as serious hepatic disorder, renal disorder, heart disease, lung disease, hematological disease, and metabolic disease. etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>The presence or absence of adverse events/reactions and their incidence, etc.
- Secondary Outcome Measures
Name Time Method efficacy<br>ADHD RS-IV, etc.