An Open-label Study of NRP104 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
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)
1 other identifier
interventional
349
1 country
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2006
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2006
CompletedFirst Posted
Study publicly available on registry
June 15, 2006
CompletedStudy Start
First participant enrolled
July 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
July 17, 2009
CompletedAugust 20, 2012
August 1, 2012
1.3 years
June 9, 2006
May 28, 2009
August 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in ADHD-RS-IV Total Score From Baseline at 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.
up to one year
Secondary Outcomes (2)
Number of Participants With Improvement on CGI-I
Up to 1 year
Change in PSQI Total Score From Baseline at Up to One Year
up to 1 year
Study Arms (1)
1
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- Subject must be 18-55 years of age, inclusive, at the time of consent of the NRP104.303 study.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- New River Pharmaceuticalslead
- Shirecollaborator
Study Sites (45)
Clinical Study Centers, LLC
Little Rock, Arkansas, 72205, United States
Valley Clinical Research, Inc.
El Centro, California, 92243, United States
University of California, Irvine Child Development Center
Irvine, California, 92612, United States
Bay Area Research Institute
Lafayette, California, 94549, United States
Peninsula Research Associates
Rolling Hills Estate, California, 90274, United States
University of California, San Francisco, Dept. of Psychiatry
San Francisco, California, 94143, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Alpine Clinical Research Center
Boulder, Colorado, 80304, United States
Psychiatric Medicine Center
New London, Connecticut, 06320, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912, United States
Miami Research Associates
Miami, Florida, 33173, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806, United States
Meridien Research
Tampa, Florida, 33606, United States
Janus Center for Psychiatric Research LLC
West Palm Beach, Florida, 33407, United States
Northwest Behavioral Research Center
Roswell, Georgia, 30076, United States
Carman Research
Smyrna, Georgia, 30080, United States
Psychiatric Associates
Overland Park, Kansas, 66211, United States
Vince and Associates Clinical Research
Overland Park, Kansas, 66212, United States
Johns Hopkins at Green Spring Station
Lutherville, Maryland, 21093, United States
Marc Hertzman, MD
Rockville, Maryland, 20852, United States
Masschusetts General Hospital
Cambridge, Massachusetts, 02138, United States
Summit Research Network (Michigan) Inc.
Flint, Michigan, 48507, United States
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307, United States
St Charles Psychiatric Associates-Midwest Research
Saint Charles, Missouri, 63301, United States
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, 89128, United States
CNS Research Institute (CRI)
Clementon, New Jersey, 08021, United States
VA New York Harbor Healthcare System
New York, New York, 10010, United States
Duke University ADHD Program
Durham, North Carolina, 27705, United States
Richard Weisler and Associates
Raleigh, North Carolina, 27609, United States
The Ohio State University
Columbus, Ohio, 43210, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, 97210-2659, United States
CNS Research Institute, P.C.
Philadelphia, Pennsylvania, 19149, United States
FutureSearch Trials
Austin, Texas, 78756, United States
Claghorn-Lesem Research Clinic
Bellaire, Texas, 77401, United States
Bayou City Research
Houston, Texas, 77007, United States
Red Oak Psychiatry Associates, P.A.
Houston, Texas, 77090, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566, United States
John M. Turnbow, MD, PA
Lubbock, Texas, 79423, United States
The Clinical Study Center
Burlington, Vermont, 05401, United States
Neuropsychiatric Associates
Woodstock, Vermont, 05091, United States
Psychiatric Alliance of the Blue Ridge Clinical Research
Charlottesville, Virginia, 22903, United States
NeuroScience, Inc.
Herndon, Virginia, 20170, United States
Brighton Research Group
Virginia Beach, Virginia, 23452, United States
Summit Research Network LLC (Seattle)
Seattle, Washington, 98104, United States
Related Publications (2)
Ginsberg L, Katic A, Adeyi B, Dirks B, Babcock T, Lasser R, Scheckner B, Adler LA. Long-term treatment outcomes with lisdexamfetamine dimesylate for adults with attention-deficit/hyperactivity disorder stratified by baseline severity. Curr Med Res Opin. 2011 Jun;27(6):1097-107. doi: 10.1185/03007995.2011.567256. Epub 2011 Mar 28.
PMID: 21438796RESULTMattingly G, Weisler R, Dirks B, Babcock T, Adeyi B, Scheckner B, Lasser R. Attention deficit hyperactivity disorder subtypes and symptom response in adults treated with lisdexamfetamine dimesylate. Innov Clin Neurosci. 2012 May;9(5-6):22-30.
PMID: 22808446RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Timothy Whitaker
- Organization
- Shire Pharmaceutical Development, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Biederman, M.D.
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 9, 2006
First Posted
June 15, 2006
Study Start
July 1, 2006
Primary Completion
November 1, 2007
Study Completion
June 1, 2008
Last Updated
August 20, 2012
Results First Posted
July 17, 2009
Record last verified: 2012-08