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COMPLETED Phase 3

Study to Evaluate the Efficacy of Modafinil Treatment in Patients With Attention Deficit Hyperactivity Disorder (ADHD) Who Are Responders to Modafinil Treatment

NCT00343811 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate the continued efficacy of modafinil treatment, compared to placebo treatment, in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who are responders to modafinil treatment.

Interventions

  • DRUG Modafinil

Study Locations (20)

California

  • UCI Child Development Center — Irvine
  • University of California at San Francisco — San Francisco
  • Encompass Clinical Research — Spring Valley

Florida

  • Sarkis Family Psychiatry — Gainesville
  • Amedica Research Institute, Inc. — Hialeah
  • Miami Research Associates — Miami

Kentucky

  • Kentucky Pediatric/Adult Research — Bardstown
  • Michael J. Rieser, MD, PSC — Lexington
  • Four Rivers Clinical Research, Inc. — Paducah

North Carolina

  • Piedmont Neuropsychiatry — Charlotte
  • Triangle Neuropsychiatry — Durham

Arkansas

  • Clinical Study Centers, LLC — Little Rock

Colorado

  • Alpine Clinical Research — Boulder

Georgia

  • Child Neurology Associates — Atlanta

Michigan

  • Clinical Neurophysiology Services — Troy

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2006-06
Est. Completion 2006-09
Phase Phase 3

Sponsor

Cephalon

17 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00343811

The ClinicalTrials.gov registry entry for NCT00343811 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 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cephalon, which has 17 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 1 intervention — of which Modafinil 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: NCT00343811 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Kentucky. 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 NCT00343811 about?

NCT00343811 is a clinical study titled "Study to Evaluate the Efficacy of Modafinil Treatment in Patients With Attention Deficit Hyperactivity Disorder (ADHD) Who Are Responders to Modafinil Treatment". The purpose of this study is to evaluate the continued efficacy of modafinil treatment, compared to placebo treatment, in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who are responders to modafinil treatment.

What is the current status of trial NCT00343811?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2006-06. Estimated completion is 2006-09.

What conditions does trial NCT00343811 study?

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

What interventions are being tested in trial NCT00343811?

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

Who is sponsoring clinical trial NCT00343811?

This trial is sponsored by Cephalon, which has 17 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00343811 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. 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