NCT00152022

Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.

Completed Phase 3 Last updated 13 July 2021

What this trial tests

Phase 3 trial testing Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulphate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate. in Attention Deficit Disorder With Hyperactivity in 412 participants. Completed in 4 November 2005.

Timeline

25 April 2005

Primary endpoint
4 November 2005

4 November 2005

Quick facts

Lead sponsor	Shire
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	412
Start date	25 April 2005
Primary completion	4 November 2005
Estimated completion	4 November 2005

Drugs / interventions tested

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

Conditions studied

• Attention Deficit Disorder With Hyperactivity — all drugs for Attention Deficit Disorder With Hyperactivity →

Sponsor

Shire — full company profile →

Who can join

Adults 18 to 55, any sex, with Attention Deficit Disorder With Hyperactivity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 the participants sleep and how they perceive their quality of life.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Amphetamines for attention deficit hyperactivity disorder (ADHD) in adults.
   Castells X, Blanco-Silvente L, Cunill R. · · 2018 · cited 66× · PMID 30091808 · DOI 10.1002/14651858.cd007813.pub3
2. Impact of stimulant pharmacotherapy on sleep quality: post hoc analyses of 2 large, double-blind, randomized, placebo-controlled trials.
   Surman CB, Roth T. · · 2011 · cited 34× · PMID 21824454 · DOI 10.4088/jcp.11m06838
3. Improved Executive Function in Adults Diagnosed With Attention-Deficit/ Hyperactivity Disorder as Measured by the Brown Attention-Deficit Disorder Scale Following Treatment With SHP465 Mixed Amphetamine Salts Extended-Release: Post Hoc Analyses From 2 Randomized, Placebo-Controll
   Brown TE, Chen J, Robertson B. · · 2022 · cited 8× · PMID 33150816 · DOI 10.1177/1087054720961819
4. <i>Post hoc</i> Responder and Remission Analyses from Two Studies of SHP465 Mixed Amphetamine Salts Extended-Release Among Adults with Attention-Deficit/Hyperactivity Disorder.
   Adler LA, Robertson B, Chen J, Sarkis E. · · 2020 · cited 2× · PMID 32423239 · DOI 10.1089/cap.2020.0012
5. A simple formula for enumerating comparisons in trials and network meta-analysis.
   Shokraneh F, Adams CE. · · 2019 · cited 2× · PMID 30863537 · DOI 10.12688/f1000research.17352.2