A 6-month, open-label extension to a 40-week, randomized, double-blind, placebo-controlled, multicenter efficacy and safety study of Ritalin® LA in the treatment of adult patients with childhood-onset ADHD

Active, not recruiting

• Conditions: Adult patients with childhood-onset Attention Deficit Hyperactivity Disorder; MedDRA version: 13.1Level: LLTClassification code 10003735Term: Attention deficit-hyperactivity disorderSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 13.1Level: LLTClassification code 10003737Term: Attention deficit/hyperactivity disorder NOSSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 13.1Level: PTClassification code 10003736Term: Attention deficit/hyperactivity disorderSystem Organ Class: 10037175 - Psychiatric disorders

• Registration Number: EUCTR2011-000210-19-DK
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-05
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

•Patients who have completed the 40-week core study CRIT124D2302 and Week 40 (End of Study) assessments,
or
patients who met the predefined criteria for treatment failure (=30% worsening on DSM IV ADHD RS during Period 3 of the core study), were withdrawn from the core study, and have completed core-study Week 40 assessments (Premature Discontinuation Visit).
•Patients must give written informed consent before any study related activity of this extension protocol is performed.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients who during the core study developed any psychiatric condition, including anxiety, tension, agitation, aggressive behavior, psychotic symptoms, suicidal tendency, that requires treatment with medication or that, in the judgment of the investigator, may interfere with study participation and /or study assessments.
•Patients who during the core study developed cardiovascular disorders including severe hypertension, angina, arterial occlusive disease, heart failure, hemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies (disorders caused by the dysfunction of ion channels).
•Evidence upon physical examination during the core study of any clinically significant respiratory, hepatic, gastrointestinal, renal, hematological, or oncologic disorder requiring current medical intervention/therapy or likely to have a significant impact on the outcome of this study
•Patients with a positive urine drug test at the End of Study (Week 40)/Premature discontinuation visit.
•Patients with an abnormal ECG at the End of Study (Week 40)/Premature discontinuation visit.
•Patients who developed any seizure condition during the core study.
•Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma.
•Diagnosis or family history of Tourette’s syndrome.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •To evaluate the long-term safety of Ritalin LA administered once daily for six months during open-label treatment in adults with ADHD. ;Secondary Objective: •To characterize the long-term benefit of Ritalin LA administered once daily for six months during open-label treatment in adults with ADHD, as measured by the change from baseline (Core study Visit 20, Week 40 or early discontinuation visit) to the end of the extension study (Visit 30, Week 66) in DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) total score <br>•To evaluate improvement in functional impairment as measured by change from baseline in total score on the Sheehan Disability Scale (SDS).<br>;Primary end point(s): To evaluate the long-term safety of Ritalin LA administered once daily for six months during open-label treatment in adults with ADHD. The evaluation of safety is considered primary in this open-label extension.