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An Open-label Study of NRP104 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

NCT00337285 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 349

Last updated 2012-08-20

Study results available
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Summary

The purpose of this study is to assess the long-term safety and efficacy of three NRP104 doses of 30 mg, 50 mg, or 70 mg, administered at the same time daily, in the treatment of adults with ADHD.

Conditions

  • Attention Deficit Hyperactivity Disorder
  • Attention Deficit Disorders With Hyperactivity
  • Attention Deficit Hyperactivity Disorders

Interventions

DRUG

Vyvanse (lisdexamfetamine dimesylate), NRP104

NRP104 capsule once-a-day orally beginning at 30mg/day and titrated by 20 mg per day at weekly intervals up to a maximum daily dose of 70 mg

Sponsors & Collaborators

  • Shire

    collaborator INDUSTRY

  • New River Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Joseph Biederman, M.D. · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2007-11-30
Completion
2008-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00337285 on ClinicalTrials.gov