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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
314
Optimized dose of either 30, 50 or 70 mg capsule administered once daily for 2 years
ZNA Antwerpen, Commandant Weynsstraat 165 Campus Hoge Beuken
Hoboken, Antwerp, Belgium
Afdeling Psychiatrie
Leuven, Belgium
Albert-Ludwigs-Universität Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Zentralinstitut für Seelische Gesundheit Mannheim
Mannheim, Baden-Wurttemberg, Germany
Schwerpunktpraxis für Entwicklung und Lernen
Bamberg, Bavaria, Germany
Number of Participants With All Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. It included both serious and non-serious adverse event. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
Time frame: Baseline up to 3 days after the last dose of study treatment (up to 2 years)
Change From Baseline in Pulse Rate at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in Body Weight at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in Height at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in Body Mass Index (BMI) at Last On-treatment Assessment (LOTA)
BMI was calculated as (weight \[kilogram\] per height \[square meter\]).
Time frame: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in Heart Rate at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in QT Interval at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRSC) Total Scores at Last On-treatment Assessment (LOTA)
The BPRS-C that was designed to provide a characterization of the child and adolescent psychopathology, was used to monitor participant's safety. The BPRS-C assessed 7 independent factors (3 items each), for a total of 21 items that represented behavioural disorders, depression, thinking disturbance, psychomotor excitation, withdrawal retardation, anxiety, and organicity. Each item was rated using a 7-point scale including 0 (not present), 1 (very mild), 2 (mild), 3 (moderate), 4 (moderately severe), 5 (severe), and 6 (extremely severe). Total score is the sum of each item score; range from 0 to 126. Higher score indicated worse psychology.
Time frame: Baseline (Week 0), LOTA (Week 104)
Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Last On-treatment Assessment (LOTA)
ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria, completed by the Investigator. Each item was scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items were grouped into 2 sub-scales: hyperactivity/impulsivity (even number items 2-18 with score range of 0 to 27) and inattention (odd number items 1-17 with score range of 0 to 27). Higher scores depicted worse symptoms.
Time frame: Baseline (Week 0), LOTA (Week 104)
Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA)
The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-I was a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), evaluated by the Investigator.
Time frame: LOTA (Week 104)
Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA)
The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-S was a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants), evaluated by the Investigator.
Time frame: LOTA (Week 104)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Medizinisches Studienzentrum Würzburg
Würzburg, Bavaria, Germany
Praxis Dr.Christian Wolff
Hagen, North Rhine-Westphalia, Germany
Universitätsmedizin Berlin
Berlin, Germany
Praxis Dr. med. Friedrich Kaiser und Dr. med. Ingrid Marinesse
Hamburg, Germany
Gyermek es Ifjusagpszichiatriai Szakrendeles es Gondozo Veress E. u. 2.
Pécs, Baranya, Hungary
...and 25 more locations