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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00337285
Recruitment Status : Completed
First Posted : June 15, 2006
Results First Posted : July 17, 2009
Last Update Posted : August 20, 2012
Information provided by:
New River Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Attention Deficit Disorders With Hyperactivity Attention Deficit Hyperactivity Disorders Drug: Vyvanse (lisdexamfetamine dimesylate), NRP104 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 349 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-Term, Open-Label, and Single-Arm Study of NRP104 30 mg, 50 mg, or 70 mg Per Day in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Study Start Date : July 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : June 2008

Arm Intervention/treatment
Experimental: 1 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

Primary Outcome Measures :
  1. Change in ADHD-RS-IV Total Score From Baseline at Up to One Year [ Time Frame: up to one year ]
    Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.

Secondary Outcome Measures :
  1. Number of Participants With Improvement on CGI-I [ Time Frame: Up to 1 year ]
    Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes 1 and 2 on the scale.

  2. Change in PSQI Total Score From Baseline at Up to One Year [ Time Frame: up to 1 year ]
    Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire consisting of 18 items which generates seven component scores on a scale from 0 (better sleep) to 3 (worse sleep) resulting in a global score of 0-21, where a higher number reflects worse sleep quality.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject must be 18-55 years of age, inclusive, at the time of consent of the NRP104.303 study.
  • Subject must have been randomized and must have met all inclusion/exclusion criteria in the NRP104.303 study.
  • Subject must be male or non-pregnant female. Females of childbearing potential (FOCP) must comply with contraceptive restrictions noted in the protocol.
  • Subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by medical history, PE, clinical and laboratory evaluation.
  • In the opinion of the investigator, the subject understands and is able, willing, and likely to fully comply with the study procedures and restrictions.
  • Subject must have given written, personally signed and dated informed consent to participate in the study in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines and applicable regulations before completing any study specific procedures.
  • Subject experienced no adverse events in a previous study of NRP104 or elsewhere that would preclude continued exposure to NRP104.

Exclusion Criteria:

  • Subject has any concurrent chronic or acute illness or unstable medical condition that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol. Subjects who have a history of mental retardation or a severe learning disability are excluded.
  • Subject has a known cardiac structural abnormality or any other condition that may affect cardiac performance.
  • Subject has any clinically significant ECG or laboratory abnormality known to the investigator prior to dispensation of study medication.
  • Subject has a resting sitting systolic blood pressure or diastolic blood pressure deemed clinically significant by the investigator.
  • Subject has used any prohibited prescription medication except for medications used to treat ADHD within 30 days of screening visit. Hormonal contraceptives are acceptable.
  • Subject has a positive urine drug result at Screening (with the exception of subject's current stimulant therapy, if any).
  • Subject has taken an investigational drug or taken part in a clinical trial within 30 days prior to Screening (except for participating in an NRP104 study).
  • The female subject is pregnant or lactating.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00337285

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Sponsors and Collaborators
New River Pharmaceuticals
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Principal Investigator: Joseph Biederman, M.D. Massachusetts General Hospital

Additional Information:
Publications of Results:
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Responsible Party: Timothy Whitaker, M.D., Shire Pharmaceutical Identifier: NCT00337285     History of Changes
Other Study ID Numbers: NRP104.304
First Posted: June 15, 2006    Key Record Dates
Results First Posted: July 17, 2009
Last Update Posted: August 20, 2012
Last Verified: August 2012
Keywords provided by New River Pharmaceuticals:
Attention Deficit Hyperactivity Disorder
Attention Deficit Disorders with Hyperactivity
Attention Deficit Hyperactivity Disorders
Additional relevant MeSH terms:
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Lisdexamfetamine Dimesylate
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents