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COMPLETED Phase 3

Study to Assess the Safety and Efficacy of NRP104 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

NCT00334880 · View on ClinicalTrials.gov ↗

Study Summary

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).

Interventions

  • DRUG NRP104

Study Locations (20)

California

  • Valley Clinical Research, Inc. — El Centro
  • University of California, Irvine Child Development Center — Irvine
  • Bay Area Research Institute — Lafayette
  • Peninsula Research Associates — Rolling Hills Estate
  • University of California, San Francisco, Dept. of Psychiatry — San Francisco
  • Encompass Clinical Research — Spring Valley

Florida

  • Gulfcoast Clinical Research Center — Fort Myers
  • Miami Research Associates — Miami
  • Clinical Neuroscience Solutions, Inc. — Orlando
  • Meridien Research — Tampa
  • Janus Center for Psychiatric Research LLC — West Palm Beach

Connecticut

  • Yale University School of Medicine — New Haven
  • Psychiatric Medicine Center — New London

Georgia

  • Northwest Behavioral Research Center — Roswell
  • Carman Research — Smyrna

Kansas

  • Psychiatric Associates — Overland Park
  • Vince and Associates Clinical Research — Overland Park

Arkansas

  • Clinical Study Centers, LLC — Little Rock

Colorado

  • Alpine Clinical Research Center — Boulder

Maryland

  • Johns Hopkins at Green Spring Station — Lutherville

Trial Details

FieldValue
Enrollment Target 420 participants
Start Date 2006-05
Est. Completion 2006-11
Phase Phase 3

Sponsor

New River Pharmaceuticals

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00334880

The ClinicalTrials.gov registry entry for NCT00334880 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 420 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New River Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 1 intervention — of which NRP104 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00334880 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00334880 about?

NCT00334880 is a clinical study titled "Study to Assess the Safety and Efficacy of NRP104 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)". 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).

What is the current status of trial NCT00334880?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 420 participants. The study started on 2006-05. Estimated completion is 2006-11.

What conditions does trial NCT00334880 study?

This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder, Attention Deficit Disorders With Hyperactivity, Attention Deficit Hyperactivity Disorders. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00334880?

The interventions under investigation include: NRP104 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00334880?

This trial is sponsored by New River Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00334880 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial