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Safety & Tolerability of MTS in Children Aged 6-12 Diagnosed With ADHD & Previously Treated With Extended-Release Methylphenidate Therapy

NCT00151983 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2015-07-09

No results posted yet for this study

Summary

This study will assess the safety and tolerability of MTS while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.

Conditions

  • Attention Deficit Disorder With Hyperactivity

Interventions

DRUG

Methylphenidate Transdermal System

To assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo

Sponsors & Collaborators

  • Noven Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Noven Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2006-07-31
Completion
2006-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00151983 on ClinicalTrials.gov