Safety of SPD465 in Treating Adults With ADHD.

Shire

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.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00152035

SPD465-304

Details and patient eligibility

About

The purpose of this study is to assess the safety and effectiveness of SPD465 in the treatment of ADHD. The study will also look at how SPD465 affects sleep.

Enrollment: 505 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject satisfied all entry criteria for the antecedent protocol (SPD465-301 or SPD465-303) and completed a minimum of 4 of the 7 weeks of double-blind treatment without experiencing any clinically significant adverse events.
• Subject must be male or non-pregnant female who agrees to comply with using acceptable contraceptive methods.

Exclusion criteria

• Subject was terminated from antecedent protocol (SPD465-301 or SPD465-303) for non-compliance and/or experienced a serious adverse event or adverse event resulting in termination from the protocol.
• Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Asix I disorders.
• History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
• Females who are pregnant of lactating.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)