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OpenTrials
Completed

NCT Number: NCT00152035

Safety of SPD465 in Treating Adults With ADHD.

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.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Primary outcomes

  1. 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.

    Time frame: Throughout the study period of approximately 20 months

Secondary outcomes

  1. ADHD-rating scale (ADHD-RS-IV) taken at the Visit 1 and all visits thereafter.

    Time frame: Baseline, Weekly for 4 weeks, and then Monthly for 5 months.

  2. Clinical Global Impression of Improvement scale assessed at Visits 1 through 15/Early Termination (ET).

    Time frame: Baseline, Weekly for 4 weeks, and then Monthly for 5 months.

  3. Pittsburgh Sleep Quality Index (PSQI) - assessed at Visits 1 through 15/ET.

    Time frame: Baseline, Weekly for 4 weeks, and then Monthly for 5 months.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 9, 2005
Registry last updated
Aug 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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