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

Completed · Phase 3

Conditions studied: Attention Deficit Hyperactivity Disorder, Attention Deficit Disorders With Hyperactivity, Attention Deficit Hyperactivity Disorders

In brief

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.

Key facts

Study ID

NCT00337285

Run by

New River Pharmaceuticals

People needed

349

Starts

2006-07-01

Expected to finish

2008-06-01

Last updated by the study team

2012-08-20

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Study Centers, LLC — Little Rock, Arkansas, United States
• Valley Clinical Research, Inc. — El Centro, California, United States
• University of California, Irvine Child Development Center — Irvine, California, United States
• Bay Area Research Institute — Lafayette, California, United States
• Peninsula Research Associates — Rolling Hills Estate, California, United States
• University of California, San Francisco, Dept. of Psychiatry — San Francisco, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• Alpine Clinical Research Center — Boulder, Colorado, United States
• Psychiatric Medicine Center — New London, Connecticut, United States
• Gulfcoast Clinical Research Center — Fort Myers, Florida, United States
• Miami Research Associates — Miami, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• Meridien Research — Tampa, Florida, United States
• Janus Center for Psychiatric Research LLC — West Palm Beach, Florida, United States
• Northwest Behavioral Research Center — Roswell, Georgia, United States
• Carman Research — Smyrna, Georgia, United States
• Psychiatric Associates — Overland Park, Kansas, United States
• Vince and Associates Clinical Research — Overland Park, Kansas, United States
• Johns Hopkins at Green Spring Station — Lutherville, Maryland, United States
• Marc Hertzman, MD — Rockville, Maryland, United States
• Masschusetts General Hospital — Cambridge, Massachusetts, United States
• Summit Research Network (Michigan) Inc. — Flint, Michigan, United States
• Rochester Center for Behavioral Medicine — Rochester Hills, Michigan, United States
• St Charles Psychiatric Associates-Midwest Research — Saint Charles, Missouri, United States
• Center for Psychiatry and Behavioral Medicine — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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