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

Novartis Pharmaceuticals1 site in 1 country299 target enrollmentApril 2011

ConditionsAttention Deficit/Hyperactivity Disorder

InterventionsRitalin LA (methylphenidate hydrochloride extended release)

DrugsRitalin LA (methylphenidate hydrochloride extended release)

Overview

Phase: Phase 3
Intervention: Ritalin LA (methylphenidate hydrochloride extended release)
Conditions: Attention Deficit/Hyperactivity Disorder
Sponsor: Novartis Pharmaceuticals
Enrollment: 299
Locations: 1
Primary Endpoint: Number of Participants With Adverse Events, Serious Adverse Events and Deaths.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

April 2011

End Date

February 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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and Week 40 (End of Study) assessments or Patients who meet predefined criteria for treatment failure, were withdrawn from the core study, and have completed core-study week 40 assessments (Premature Discontinuation Visit)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

•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.
•Patients who during the core study developed cardiovascular disorders.
•Pregnant women.
•Patients who developed seizures during the core study.
•Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma.
•Diagnosis or family history of Tourette's syndrome.
•Patients who during the core study developed cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis and stroke
•Other protocol-defined inclusion/exclusion criteria may apply

Arms & Interventions

Ritalin LA

All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40, 60 or 80 mg/day).

Intervention: Ritalin LA (methylphenidate hydrochloride extended release)

Outcomes

Primary Outcomes

Number of Participants With Adverse Events, Serious Adverse Events and Deaths.

Time Frame: Week 40 - Week 66

Adverse Events, Serious Adverse Events and Deaths were monitored from week 40 to week 66.

Secondary Outcomes

Change From Extension Baseline (Week 40) to End of Study (Week 66) on Sheehan Disability Scale (SDS) Total Score(week 40 - week 66)
Change From Extension Baseline (Week 40) to End of Study (Week 66) in on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score.(week 40 - week 66)