attention deficit hyperactivity disorder (ADHD) MedDRA version: 9.1 Level: LLT Classification code 10064104 Term: ADHD
Conditions
Interventions
Trade Name: Ritalin LA 20 mg-Kapseln
Product Name: Ritalin LA 20 mg - Kapseln
Pharmaceutical Form: Modified-release capsule, hard
INN or Proposed INN: Methylphenidathydrochloride
CAS Number: 298-59-9
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 6-12 2. Patients having a confirmed diagnosis of ADHD of any type according to DSM-IV criteria, as established by history and adequate exploration 3. Patients whose symptoms are adequately controlled by a stable and well-tolerated dose of an IR- or ER-MPH equivalent of 20 or 40 mg IR-MPH for one month before screening 4. Patients with parents or a legal guardian, who will give written informed consent for the child to participate in the study. Additionally, consent 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 para. 4 No. 4 AMG). Consent will be documented by the child´s signature on the consent form. 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
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 and safety assessments 3. Patients with comorbid moderate to severe eating disorder (e.g. bulimia, anorexia nervosa, binge eating) 4. Clinically significant diseases or significant abnormal findings during the initial exam in the opinion of the investigator 5. Patients with a BMI outside the 10th and 90th age percentile 6. Patients who are taking any concomitant medications likely to interfere with the study drug or to 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 7. Patients with a known non-response to methylphenidate 8. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures 9. 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 10. Patients with a history of seizure disorder 11. Patients with contraindications mentioned in the German product information of Ritalin®: 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, use of MAO-inhibitors, history of any addictive disorder, congenital heart anomalies 12. Temporarily discontinuation of MPH-medication is not justified in the opinion of the investigator 13. Patients not 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 testings (basic knowledge of reading, writing and calculating) 14. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer 15. 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 16. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml) 17. 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that Ritalin® LA has comparable efficacy after a very light breakfast compared to a standard continental breakfast in children with ADHD after treatment for one week assessed by weekly teacher-based ratings (FBB-ADHS scale).;Secondary Objective: To evaluate that Ritalin® LA has comparable efficacy after a very light breakfast compared to a standard continental breakfast in children with ADHD after treatment for one week assessed by weekly parent-based ratings (FBB-ADHS scale), clinician-based rating (CGI) and objective assessments (math test, number of problems attempted and number of correct solutions). To evaluate the safety and tolerability of Ritalin® LA after a very light breakfast compared to a standard continental breakfast in children with ADHD after treatment for up to 6 months. ;Primary end point(s): The FBB-ADHS is a psychological rating scale that resembles key diagnostic criteria and typical features of ADHD. It is validated for the German version. The FBB-ADHS scale will be rated by both parents and teachers retrospectively for the last week. Both teachers and parents will be instructed by the investigator before study start. Teachers will fill out the rating scale on Friday afternoon and either fax or phone the values to the investigator who will record them in the CRF. Parents will fill out the scale during the Saturday visits. | — |
Countries
Germany
Outcome results
None listed