Loading clinical trials...

Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention Deficit/Hyperactivity Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention Deficit/Hyperactivity Disorder

A 6-month, Open-label Extension to a 40-week, Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in the Treatment of Adult Patients With Childhood-onset ADHD

NCT01338818•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study will evaluate the long-term safety of methylphenidate hydrochloride extended release in adults with attention deficit/hyperactivity disorder

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Completion of the 40-week core study CRIT124D2302 and Week 40 (End of Study) assessments or Patients who meet predefined criteria for treatment failure, were withdrawn from the core study, and have completed core-study week 40 assessments (Premature Discontinuation Visit)

Exclusion Criteria

•1. Patients who, during the core study, developed any psychiatric condition that requires treatment with medication or that may interfere with study participation and /or study assessments.
•2. Patients who during the core study developed cardiovascular disorders.
•3. Pregnant women.
•4. Patients who developed seizures during the core study.
•5. Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma.
•6. Diagnosis or family history of Tourette's syndrome.
•7. Patients who during the core study developed cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis and stroke

Locations (48)

Novartis Investigative Site

Little Rock, Arkansas, United States

Novartis Investigative Site

Beverly Hills, California, United States

Novartis Investigative Site

Spring Valley, California, United States

Novartis Investigative Site

Bradenton, Florida, United States

Novartis Investigative Site

Orlando, Florida, United States

Novartis Investigative Site

West Plam Beach, Florida, United States

Novartis Investigative Site

Libertyville, Illinois, United States

Novartis Investigative Site

Owensboro, Kentucky, United States

Novartis Investigative Site

Las Vegas, Nevada, United States

Novartis Investigative Site

Las Vegas, Nevada, United States

Key Dates

Start Date

April 1, 2011

Primary Completion Date

February 1, 2013

Completion Date

February 1, 2013

Last Updated

November 24, 2014

Enrollment

299

ACTUAL participants

Conditions

Attention Deficit/Hyperactivity Disorder

Interventions

Ritalin LA (methylphenidate hydrochloride extended release)

DRUG

Optimizing Research With Diverse Families - Feasibility and Acceptability Study (FAST)

NCT06133231

Attention Deficit/Hyperactivity DisorderEmotional Dysfunction+1 more

View study

COMPLETEDEARLY_PHASE1

Oxytocin and Cognitive Control in Adult ADHD

NCT03136263

Attention Deficit/Hyperactivity Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 24, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention Deficit/Hyperactivity Disorder

Inclusion Criteria

Exclusion Criteria

Optimizing Research With Diverse Families - Feasibility and Acceptability Study (FAST)

Oxytocin and Cognitive Control in Adult ADHD

Chantix in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD)

Pilot Trial Comparing Computerised Cognitive Exercises to Tetris in Adolescents With ADHD

Near Infrared Spectroscopy Neurofeedback Training for ADHD

Cost-effectiveness of the Treatment of Attention Deficit/Hyperactivity Disorder With Methylphenidate Immediate-release in Brazil