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COMPLETED Phase 3

Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)

NCT01259492 · View on ClinicalTrials.gov ↗

Study Summary

This study will evaluate efficacy and safety of methylphenidate hydrochloride extended release compared to placebo in adult patients with childhood-onset attention deficit/hyperactivity disorder (ADHD).

Interventions

  • DRUG Placebo
  • DRUG Ritalin LA 20 mg
  • DRUG Ritalin LA 30 mg

Study Locations (20)

Florida

  • Novartis Investigative Site — Bradenton
  • Novartis Investigative Site — Miami
  • Novartis Investigative Site — Orlando
  • Novartis Investigative Site — West Plam Beach

California

  • Novartis Investigative Site — Beverly Hills
  • Novartis Investigative Site — Spring Valley

Nevada

  • Novartis Investigative Site — Las Vegas
  • Novartis Investigative Site — Las Vegas

Texas

  • Novartis Investigative Site — Houston
  • Novartis Investigative Site — Houston

Arkansas

  • Novartis Investigative Site — Little Rock

Illinois

  • Novartis Investigative Site — Libertyville

Kentucky

  • Novartis Investigative Site — Owensboro

Michigan

  • Novartis Investigative Site — Troy

Trial Details

FieldValue
Enrollment Target 725 participants
Start Date 2010-11
Est. Completion 2012-08
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01259492

The ClinicalTrials.gov registry entry for NCT01259492 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 725 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 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 3 interventions — of which Placebo 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: NCT01259492 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Florida, California, Nevada. 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 NCT01259492 about?

NCT01259492 is a clinical study titled "Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)". This study will evaluate efficacy and safety of methylphenidate hydrochloride extended release compared to placebo in adult patients with childhood-onset attention deficit/hyperactivity disorder (ADHD).

What is the current status of trial NCT01259492?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 725 participants. The study started on 2010-11. Estimated completion is 2012-08.

What conditions does trial NCT01259492 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 NCT01259492?

The interventions under investigation include: Placebo (DRUG), Ritalin LA 20 mg (DRUG), Ritalin LA 30 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01259492?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01259492 being conducted?

This trial has 20 study locations across Arkansas, California, Florida, Illinois, Kentucky. 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