Full Text View
Tabular View
Study Results
Related Studies
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

  Hide Study Locations
Locations
United States, Arkansas
Clinical Study Centers, LLC
Little Rock, Arkansas, United States, 72205
United States, California
Bay Area Research Institute
LaFayette, California, United States, 94549
Encompass Clinical Research
Spring Valley, California, United States, 91978
Peninsula Research Associates
Rolling Hills Estate, California, United States, 90274
Valley Clinical Research, Inc.
El Centro, California, United States, 92243
University of California, San Francisco, Dept. of Psychiatry
San Francisco, California, United States, 94143
University of California, Irvine Child Development Center
Irvine, California, United States, 92612
United States, Colorado
Alpine Clinical Research Center
Boulder, Colorado, United States, 80304
United States, Connecticut
Psychiatric Medicine Center
New London, Connecticut, United States, 06320
United States, Florida
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States, 32806
Janus Center for Psychiatric Research LLC
West Palm Beach, Florida, United States, 33407
Miami Research Associates
Miami, Florida, United States, 33173
Meridien Research
Tampa, Florida, United States, 33606
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States, 33912
United States, Georgia
Carman Research
Smyrna, Georgia, United States, 30080
Northwest Behavioral Research Center
Roswell, Georgia, United States, 30076
United States, Kansas
Psychiatric Associates
Overland Park, Kansas, United States, 66211
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66212
United States, Maryland
Johns Hopkins at Green Spring Station
Lutherville, Maryland, United States, 21093
Marc Hertzman, MD
Rockville, Maryland, United States, 20852
United States, Massachusetts
Masschusetts General Hospital
Cambridge, Massachusetts, United States, 02138
United States, Michigan
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, United States, 48307
Summit Research Network (Michigan) Inc.
Flint, Michigan, United States, 48507
United States, Missouri
St Charles Psychiatric Associates-Midwest Research
St Charles, Missouri, United States, 63301
United States, Nevada
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, United States, 89128
United States, New Jersey
CNS Research Institute (CRI)
Clementon, New Jersey, United States, 08021
United States, New York
VA New York Harbor Healthcare System
New York, New York, United States, 10010
United States, North Carolina
Richard Weisler and Associates
Raleigh, North Carolina, United States, 27609
Duke University ADHD Program
Durham, North Carolina, United States, 27705
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Oklahoma
IPS Research Company
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, United States, 97210-2659
United States, Pennsylvania
CNS Research Institute, P.C.
Philadelphia, Pennsylvania, United States, 19149
United States, Texas
Bayou City Research
Houston, Texas, United States, 77007
Claghorn-Lesem Research Clinic
Bellaire, Texas, United States, 77401
FutureSearch Trials
Austin, Texas, United States, 78756
John M. Turnbow, MD, PA
Lubbock, Texas, United States, 79423
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States, 77566
Red Oak Psychiatry Associates, P.A.
Houston, Texas, United States, 77090
United States, Vermont
Neuropsychiatric Associates
Woodstock, Vermont, United States, 05091
The Clinical Study Center
Burlington, Vermont, United States, 05401
United States, Virginia
Brighton Research Group
Virginia Beach, Virginia, United States, 23452
NeuroScience, Inc.
Herndon, Virginia, United States, 20170
Psychiatric Alliance of the Blue Ridge Clinical Research
Charlottesville, Virginia, United States, 22903
United States, Washington
Summit Research Network LLC (Seattle)
Seattle, Washington, United States, 98104
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 27, 2009