Safety of SPD465 in Treating Adults With ADHD.

A Phase III, Multi-center, 12-month, Open-label Safety Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00152035

Enrollment

505

Registered

2005-09-09

Start date

2005-03-10

Completion date

2006-11-07

Last updated

2021-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Disorder With Hyperactivity

Brief summary

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.

Interventions

DRUGNeutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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.

Design outcomes

Primary

Measure	Time frame
The evaluation of safety will be based on the occurrence of treatment emergent AEs and specific evaluation of vitals signs, ECG, laboratory and physical examination.	Throughout the study period of approximately 20 months

Secondary

Measure	Time frame
ADHD-rating scale (ADHD-RS-IV) taken at the Visit 1 and all visits thereafter.	Baseline, Weekly for 4 weeks, and then Monthly for 5 months.
Clinical Global Impression of Improvement scale assessed at Visits 1 through 15/Early Termination (ET).	Baseline, Weekly for 4 weeks, and then Monthly for 5 months.
Pittsburgh Sleep Quality Index (PSQI) - assessed at Visits 1 through 15/ET.	Baseline, Weekly for 4 weeks, and then Monthly for 5 months.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026