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NCT01070394 · ClinicalTrials.gov registry record · Phase 4

Effectiveness and Duration of Effect of Open Treatment in Attention Deficit Hyperactivity Disorder (ADHD) Patients Treated With Lisdexamfetamine Dimesylate(Vyvanse)

A Phase 4 study of Attention Deficit Hyperactivity Disorder, sponsored by NYU Langone Health.

Completed
Registry status
Phase 4
Development phase
40
Enrollment target
1
Study location

NCT01070394: Completed Phase 4 study of Attention Deficit Hyperactivity Disorder, sponsored by NYU Langone Health.

NCT01070394 is a Phase 4 study of Attention Deficit Hyperactivity Disorder that has completed, run by NYU Langone Health. The registered enrollment target is 40 participants, below the 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01070394, a Phase 4 study of Attention Deficit Hyperactivity Disorder, has completed, sponsored by NYU Langone Health.

COMPLETED
Registry status
Phase 4
Development phase
40 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

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 a possible total score of 0-54. A score of 0-16 means "Unlikely to have ADHD"; a score of 17-23 "Li

Conditions Studied

Attention Deficit Hyperactivity Disorder

Interventions

  • DRUG LDX Treatment

Study Locations (1)

New York

  • NYU School of Medicine - New York

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2010-02
Est. Completion 2012-07
Phase Phase 4
NYU Langone Health

1,164 total trials

What the finished NCT01070394 record still lists

NCT01070394 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (81% lower).

The record links to 1 condition, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 1 intervention - of which LDX Treatment is the first listed.

NCT01070394 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT01070394 about?

NCT01070394 is a clinical study titled "Effectiveness and Duration of Effect of Open Treatment in Attention Deficit Hyperactivity Disorder (ADHD) Patients Treated With Lisdexamfetamine Dimesylate(Vyvanse)". 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.

What is the current status of trial NCT01070394?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2010-02. Estimated completion is 2012-07.

What conditions does trial NCT01070394 study?

This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder.

What interventions are being tested in trial NCT01070394?

The interventions under investigation include: LDX Treatment (DRUG).

Who is sponsoring clinical trial NCT01070394?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01070394 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Attention Deficit Hyperactivity Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01070394's enrollment target sits among peer trials

40 67th of 102 higher than 32 of 102 other Attention Deficit Hyperactivity Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01070394, the US trial registry maintained by the National Library of Medicine. NCT01070394 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.