NCT01070394

Evaluation of Pharmacokinetics and Profile of Clinical Response of Subacute Lisdexamfetamine Dimesylate (Vyvanse) Treatment vs. Clinical Response to Subacute Immediate Release Mixed Amphetamine Salt Therapy in Adult ADHD

Completed Phase 4 Results posted Last updated 5 March 2018

What this trial tests

Phase 4 trial testing LDX Treatment in Attention Deficit Hyperactivity Disorder in 40 participants. Completed in 1 July 2012.

Timeline

1 February 2010

Primary endpoint
1 July 2012

1 July 2012

Quick facts

Lead sponsor	NYU Langone Health
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 February 2010
Primary completion	1 July 2012
Estimated completion	1 July 2012
Sites	1 location across United States

Drugs / interventions tested

• LDX Treatment — full drug profile →

Conditions studied

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

Sponsor

NYU Langone Health — full company profile →

Who can join

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

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Attention Deficit Hyperactivity Disorder- Rating Scale (ADHS-RS)
  Time frame: 12 weeks
  The ADHD-RS with adult ADHD prompts is a semi-structured scale that consists of 18 items that directly correspond to the 18 DSM-IV symptoms of ADHD, and is designed to assess current symptomatology19. Each item is scored on a 4-point scale ranging from 0 (none) to 3 (severe).Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding

Sponsor's own description

The purpose of this study is to examine the effectiveness and length of effect of Vyvanse on lessening Attention-Deficit/Hyperactivity Disorder symptoms in adults. The study will also investigate the safety and tolerability of Vyvanse in adults with ADHD.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical response and symptomatic remission in short- and long-term trials of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder.
   Mattingly GW, Weisler RH, Young J, Adeyi B, et al · · 2013 · cited 24× · PMID 23356790 · DOI 10.1186/1471-244x-13-39