Study to Assess the Safety and Efficacy 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 evaluate the safety and effectiveness of NRP104 administered as a daily morning dose (30, 50, and 70mg/day) compared to placebo in adults (18-55 years of age inclusive) diagnosed with moderate to severe Attention Deficit Hyperactivity Disorder (ADHD).

Key facts

Study ID

NCT00334880

Run by

New River Pharmaceuticals

People needed

420

Starts

2006-05-01

Expected to finish

2006-11-01

Last updated by the study team

2009-07-02

Who can join

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

You may qualify if…

• Must be 18-55 years of age, inclusive.
• Must be male or non-pregnant female. Females of childbearing potential (FOCP) must use contraception.
• Must have a medical assessment with no clinically significant or relevant abnormalities as determined by medical history, PE, clinical and lab evaluation.
• Must have 12-lead ECGs defined by the following parameters:
• QT/QTcF interval < 450 msec for males and < 470 msec for females
• Resting heart rate is between 40 and 100 beats per minute
• P-R interval < 200 msec
• QRS interval <110 msec.
• Meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition; Text Revision (DSM-IV-TR™) criteria for a primary diagnosis of ADHD (diagnostic code 314.00 and 314.01) established by a psychiatric evaluation that reviews DSM-IV-TR™ criteria with at least 6 of the 9 subtype criteria met. The Adult ADHD Clinical Diagnostic Scale (ACDS v1.2) will be utilized as the diagnostic tool.
• Has a baseline ADHD-RS score greater than or equal to 28 assessed using adult DSM-IV prompts.
• Understands and is able, willing, and likely to fully comply with the study procedures and restrictions.
• Has given written 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 procedures.

You may not qualify if…

• In the opinion of the investigator, the subject is significantly underweight [e.g., Body Mass Index (BMI) < 18.5] or morbidly obese.
• Has any comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid Axis II disorders or severe Axis I disorders including Post Traumatic Stress Disorder (PTSD), psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder or other symptomatic manifestations that will contraindicate NRP104 treatment or confound efficacy or safety assessments. Specifically, subjects with mild to moderate forms of Axis I disorders including social phobia and dysthymia may be included while subjects with a lifetime history of psychosis or bipolar disorder will be excluded from participation. Comorbid psychiatric diagnoses will be established by a psychiatric evaluation that includes the Structured Clinical Interview for DSM-IV-TR™ disorders (SCID-I) interview at the screening visit.
• 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 with mental retardation or a severe learning disability are excluded.
• Has a history of seizure (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
• Has a known cardiac structural abnormality or any other condition that may affect cardiac performance.
• Has any clinically significant ECG or laboratory abnormality at Screening or Baseline.
• Subject has a history of hypertension or has a resting sitting systolic blood pressure > 139mmHg or diastolic blood pressure > 89mmHg.
• Has used any prohibited medication except for ADHD medications within 30 days of screening visit. Hormonal contraceptives are acceptable.
• Has a documented allergy, intolerance, or documented history of non-responsivity to methylphenidate or amphetamine.
• Currently has (or had a history within the last 6 months of) a drug dependence or substance abuse disorder according to DSM-IV-TR™ criteria (excluding nicotine) as established by a SCID-I at the screening visit.
• Has a positive urine drug result at Screening (with the exception of subject's current stimulant therapy, if any) or at Baseline.
• Has taken an investigational drug or taken part in a clinical trial within 30 days prior to Screening.
• 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
• Yale University School of Medicine — New Haven, Connecticut, 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
• Massachusetts 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.