Table of contents
- Trial overview
- Who was studied
- What was measured
- Treatment comparison and study design
- Trial status and size
- Key patient terms
Trial overview
The main clinical trial for Guanfacine in the source data was a Phase 3 interventional study in children and adolescents with ADHD.[1] It was designed to assess the long-term safety and efficacy of Guanfacine hydrochloride prolonged release, also listed as TAK-503 and SPD503.[1]
The study was completed and included 287 participants.[1]
Who was studied
The trial studied children and adolescents aged 6 to 17 years with attention-deficit/hyperactivity disorder (ADHD).[1] The study focused on patients for whom stimulants were not suitable, not tolerated, or had not worked well enough.[1]
This means the trial was aimed at young people who needed another treatment option because standard stimulant treatment was not a good fit for them.[1]
What was measured
The main safety endpoint was the change from baseline in the CANTAB RTI task.[1] This is a computer-based test that measures reaction time, attention, and psychomotor speed.[1]
The brief summary also says the study assessed cognition and interpreted the full set of data together, which means the researchers looked at the overall pattern of results, not just one test score.[1]
Treatment comparison and study design
Guanfacine prolonged release was compared with atomoxetine over 12 months of once-daily treatment.[1] Atomoxetine was used as the comparison treatment in this study.[1]
The study used the mixed-effects model for repeated measures (MMRM) to analyze the CANTAB RTI results over time.[1] This is a statistical method that helps researchers study changes across more than one time point.[1]
Trial status and size
The trial status was completed, which means the planned study activities were finished.[1] The enrollment was 287 participants, giving the study a moderate-sized group for this type of pediatric research.[1]
Key patient terms
Safety means how well the treatment is tolerated and whether problems appear during the study.[1]
Efficacy means how well the treatment works for the condition being studied.[1]
Baseline means the starting point before treatment begins.[1]
Reaction time is how quickly a person responds to a task or signal.[1]
Cognition means mental processes such as thinking and attention.[1]
