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NCT00499863 · ClinicalTrials.gov registry record · Phase 3

Evaluate the Efficacy &Safety of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD

A Phase 3 study of ADHD, sponsored by Noven Therapeutics.

Completed
Registry status
Phase 3
Development phase
217
Enrollment target
20
Study locations

NCT00499863: Completed Phase 3 study of ADHD, sponsored by Noven Therapeutics.

NCT00499863 is a Phase 3 study of ADHD that has completed, run by Noven Therapeutics. The registered enrollment target is 217 participants, above the 187-participant average among 75 other ADHD trials with a reported enrollment target (16% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00499863, a Phase 3 study of ADHD, has completed, sponsored by Noven Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
217 participants
Enrollment target
20
Study locations

Study Summary

To assess the efficacy and safety of efficacy of MTS compared to placebo

Primary Outcome

The Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG methylphenidate transdermal system

Study Locations (20)

California

  • Bay Area Research Institute - Lafayette
  • Elite Clinical Trials Inc. - Wildomar

Florida

  • Sarkis Clinical Trials - Gainesville
  • Miami Research Associates - South Miami

Kentucky

  • Shire Clinical Research Site - Lexington
  • Four Rivers Clinical Research, Inc. - Paducah

Michigan

  • Rochester Center for Behavioral Medicine - Rochester Hills
  • Clinical Neurophysiology Services, PC - Troy

North Dakota

  • Dakota Clinic/Innovis health - Fargo
  • Odyssey Research - Minot

Oregon

  • Oregon Center for Clinical Investigations, Inc. - Eugene
  • OCCI, Inc - Portland

Arizona

  • Melmed Center - Scottsdale

Georgia

  • Northwest Behavioral Research Ctr - Roswell

Trial Details

FieldValue
Enrollment Target 217 participants
Start Date 2007-07
Est. Completion 2008-05
Phase Phase 3
Noven Therapeutics

10 total trials

What the finished NCT00499863 record still lists

NCT00499863 is an interventional study that assigns participants to a tested intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap, above the 187-participant average among 75 other ADHD trials with a reported enrollment target (16% higher).

The record links to 1 condition, with ADHD appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00499863 names 20 study sites across 14 states, led by California, Florida, Kentucky.

Frequently Asked Questions

What is clinical trial NCT00499863 about?

NCT00499863 is a clinical study titled "Evaluate the Efficacy &Safety of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD". To assess the efficacy and safety of efficacy of MTS compared to placebo

What is the current status of trial NCT00499863?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 217 participants. The study started on 2007-07. Estimated completion is 2008-05.

What conditions does trial NCT00499863 study?

This clinical trial studies the following conditions: ADHD.

What interventions are being tested in trial NCT00499863?

The interventions under investigation include: Placebo (DRUG), methylphenidate transdermal system (DRUG).

Who is sponsoring clinical trial NCT00499863?

This trial is sponsored by Noven Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00499863 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for ADHD

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00499863's enrollment target sits among peer trials

217 20th of 75 higher than 56 of 75 other ADHD trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other ADHD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00499863, the US trial registry maintained by the National Library of Medicine. NCT00499863 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.