Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: ADHD
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 314
Healthy volunteers: no

Brief summary:
While the Lisdexamfetamine Dimesylate (SPD489) clinical program has studied the efficacy, safety, and tolerability of SPD489 in treating core symptoms of ADHD in children and adolescents aged 6-17 years and adults aged 18-55 years, the majority of these studies have been of short duration - up to 8 weeks.

A number of long-term studies have been undertaken (up to 1 year) and these have confirmed the safety and ongoing efficacy in this patient population.

In order to run a study with investigational medication within Poland the study changed to a Phase 3 rather than a Phase 4 study in that country. Please note that the study number remains as SPD489-404.

Study SPD489-404 has been designed to further evaluate the long-term effects of SPD489 in children and adolescents over a 2-year treatment period.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Lisdexamfetamine dimesylate
Intervention descriptions: intervention 1: Optimized dose of either 30, 50 or 70 mg capsule administered once daily for 2 years

Protocol document: