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An Open-label Study of NRP104 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
This study has been completed.
First Received: June 9, 2006   Last Updated: August 19, 2009   History of Changes
Sponsor: New River Pharmaceuticals
Collaborator: Shire Pharmaceutical Development
Information provided by: New River Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00337285
  Purpose

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 Intervention Phase
Attention Deficit Hyperactivity Disorder
Attention Deficit Disorders With Hyperactivity
Attention Deficit Hyperactivity Disorders
Drug: Vyvanse (lisdexamfetamine dimesylate), NRP104
Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:


Further study details as provided by New River Pharmaceuticals:

Primary Outcome Measures:
  • Change in ADHD-RS-IV Total Score From Baseline at Up to One Year [ Time Frame: up to one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants With Improvement on CGI-I [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Change in PSQI Total Score From Baseline at Up to One Year [ Time Frame: up to 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 349
Study Start Date: July 2006
Study Completion Date: June 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00337285

  Show 45 Study Locations
Sponsors and Collaborators
New River Pharmaceuticals
Shire Pharmaceutical Development
Investigators
Principal Investigator: Joseph Biederman, M.D. Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Shire Pharmaceutical ( Timothy Whitaker, M.D. )
Study ID Numbers: NRP104.304
Study First Received: June 9, 2006
Results First Received: May 28, 2009
Last Updated: August 19, 2009
ClinicalTrials.gov Identifier: NCT00337285     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by New River Pharmaceuticals:
Attention Deficit Hyperactivity Disorder
Attention Deficit Disorders with Hyperactivity
Attention Deficit Hyperactivity Disorders

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Central Nervous System Stimulants
Dyskinesias
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Therapeutic Uses
Dextroamphetamine
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2009