NCT00772161

Pharmacokinetics of Two Extended-Release Formulations of Methylphenidate in Children With Attention Deficit Hyperactivity Disorder (ADHD)

A Single-Center, Single-Blind, Randomized, Oral Dose Cross-Over Study in Prepuberal Boys With ADHD to Investigate Efficacy and Bioequivalence of 20 mg Ritalin LA Compared to 20 mg Medikinet Retard After Treatment With o.d. Doses Over 7 Days Each.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University Hospital Freiburg · Academic / Other
• Sex: Male
• Age: 8 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to provide pharmacokinetic data for the assessment of bioequivalence of Ritalin LA formulation compared to Medikinet ret. concerning plasma levels and efficacy measures. The primary objective of the study is to determine the pharmacokinetic parameters and bioequivalence of Ritalin LA compared to Medikinet retard, both given as oral o.d. doses of 20 mg over 7 days in children with ADHD. The secondary objectives are to assess the efficacy, safety and tolerability of Ritalin LA and Medikinet retard and the association of these parameters with plasma levels.

Detailed description

Study Design This is a single center, Phase I, prospective, randomized, single blind, two-treatment cross-over study. 24 patients will be enrolled. Study duration for each patient is approximately 4 weeks (from screening/inclusion). Based on the assumption of 5 months recruitment, the total study duration will be approximately 6 month. Target Population A number of 24 prepubertal boys aged 8 - 14 years with Diagnosis of ADHD according to DSM IV will be enrolled in this study to ensure that 18 subjects will complete all assessments. The prepuberal status will be determined by Tanner stages ≤ 2. Diagnosis will be confirmed by the K-SADS-PL. Patients will only be allowed to enter the trial if subject and subject´s parents/legal guardians provide informed consent about participation (following full explanation of the trial) and a written informed consent document is signed. In addition, it has to be verified by a physician that the patient meets all of the Inclusion Criteria and none of the Exclusion Criteria. Study Treatment Study medications will be either Ritalin LA 20 mg or Medikinet ret. 20 mg. Patients with a pre-treatment of psychotropic drugs other than Methylphenidate will have an individual washout period before inclusion to the study. This individual washout period will last 5 elimination half-life of the taken drug. After randomization the patients will enter a 2 week treatment phase with a crossover at day 8. Patients randomized to Sequence 1 will be treated with Ritalin LA for the first week (day 1 to day 7) and with Medikiniet ret. for the second week (day 8 to day 14); patients randomized to Sequence 2 will be treated with Medikinet ret. for the first week (day 1 to day 7) and with Ritalin LA for the second week (day 8 to day 14). The study population will be randomized equally to the Sequence 1 or Sequence 2 group at Visit 2. The study ends 5 weeks after enrollment of the last patient (total study end).

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Methylphenidate	Comparison of two extended-release formulations of 20mg Methylphenidate in a cross-over design.

Timeline

• Start date: 2008-10-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-10-15
• Last updated: 2009-01-21

Locations

1 site across 1 country: Germany