Efficacy and Safety of SPD465 in Adults With ADHD
Status and phase
Completed
Phase 3
Conditions
Attention Deficit Disorder With Hyperactivity
Treatments
Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate
Details and patient eligibility
About
The purpose of this study is to assess the safety and effectiveness of SPD465 compared to placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also look at how SPD465 affects sleep and how the participants perceive their quality of life.
Sex
All
Ages
18 to 55 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Primary diagnosis of ADHD
- Baseline ADHD-RS-IV score >= 24
- Non-pregnant females of childbearing potential must comply with contraceptive restrictions
Exclusion criteria
- Significantly underweight or morbidly obese
- Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Axis I disorders
- History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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