A 7 week multicenter, double-blind, randomized, placebo-controlled cross-over evaluation of the efficacy and safety of a modified-release oral dosage form of methylphenidate-HCl, Ritalin LA® (20 mg, q.d.) compared to Medikinet® ret. (20mg, q.d.) in children with attention deficit hyperactivity disorder (ADHD) aged 6 - 14

• Conditions: attention deficit hyperactivity disorder; MedDRA version: M15Level: LLTClassification code 10064104

• Registration Number: EUCTR2005-003002-28-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Male and female patients aged 6-14.
2.Patients having a diagnosis of ADHD of any type according to DSM-IV criteria, as established by history, psychiatric examination and a structured diagnostic interview (Kiddie-Sads-Present and Lifetime Version; see Appendix 3)
3.Patients, whose symptoms are adequately controlled by a stable and well-tolerated dose of a immediate release methylphenidate equivalent of 20mg for one month before screening.
4.Patients may only be included, if according to the opinion of the investigator, a discontinuation of medication is justified to assess the condition of the child.
5.Patients with parents or a legal guardian, who will give written informed consent for the child to participate in the study. Additionally, assent to participate must be obtained from all children entering the study if the child is able to judge the nature, the meaning and the significance of the clinical trial (according to §40 Abs. 4 No. 4 AMG). Assent will be documented by the child’s signature on the consent form.
6.Health status: Patients must have no clinically significant diseases or clinically significant abnormal laboratory values as assessed during medical history and physical exam.
7.Patients meeting minimum intelligence requirements: In the opinion of the investigator the patient must generally be functioning at age-appropriate levels academically, which should take into account any prior cognitive or academic testing(basic knowledge of reading, writing and calculating).
8.Female patients who have reach menarche must have a negative result on the urine pregnancy test and, if sexually active, must be using adequate and reliable contraception (e.g. triple-barrier method) throughout the course of the trial. Effective contraceptive measures are the following:
• A hormonal oral, transdermal, or injectable contraceptive agent with a double-barrier method
•An implantable contraceptive device for at least 3 months prior to screening
•A double barrier-method of contraception (condom, diaphragm and a spermicide);
9.Patients already receiving behavioral therapies for HKS/ADHD may continue to do so during the course of the trial.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients with comorbid psychiatric conditions with symptoms requiring current pharmacological treatment (e.g. major depression, psychosis).
2.Patients with comorbid psychiatric or somatic conditions that may contraindicate treatment or confound efficacy or safety assessments.
3.Patients who are taking any concomitant medications likely to interfere with the study drug or confound efficacy or safety assessments, e.g.
•Tricyclic antidepressants, buproprion, clonidine, buspirone 2 weeks before randomization.
•Atomoxetine 2 weeks before randomization.
•Fluoxetine or antipsychotics 1 month before randomization.
•Pemoline and amphetamines 1 week before randomization.
4.Patients with a known non-response to methylphenidate.
5.History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
6.Patients who are judged by the investigator as likely to be non-compliant with study procedures, including those with a suspected history of substance abuse, or patients living with a person diagnosed with a substance abuse disorder.
7.Patients who are pregnant.
8.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
9.Patients with warnings, mentioned in the German Basic Prescribing Information of Ritalin LA (Fachinformation, November 2002): anorexia, severe depression, anxiety disorder, Gilles de la Tourette-Syndrome, other tic disorder, hypertension, occlusive arterial diseases, severe stenocardia, tachycardiac arrhythmia, stroke, hyperthyroidism, increased intra-ocular pressure, hypertrophy of the prostate, known hypersensitivity to sympathomimetics, MAO-inhibitors.
10.Patients with a history of seizure disorder.
11.History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.

Study & Design

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