Safety of SPD465 in Treating Adults With ADHD.

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152035
• Other study ID #: SPD465-304
• Status: Completed
• Phase: Phase 3
• Start date: March 10, 2005
• Est. completion date: November 7, 2006

Study information

• Verified date: August 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 505
• Est. completion date: November 7, 2006
• Est. primary completion date: November 7, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Drug:
• Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	Pittsburgh Sleep Quality Index (PSQI) - assessed at Visits 1 through 15/ET.		Baseline, Weekly for 4 weeks, and then Monthly for 5 months.