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Attentin® in Children and Adolescents With ADHD - A Non-interventional Study

NCT02801604 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2020-09-02

No results posted yet for this study

Summary

The practicality of most ADHD medications is not or only moderately examined under long term routine conditions. Therefore, in this multi-centre, multi-national prospective non-interventional study, a recommended follow-up time of 12 months will investigate the course of the therapy in children and adolescents with ADHD with prior MPH treatment and their medication change to dexamfetamine in several European countries under daily routine.

It consists of a baseline visit under MPH or another ADHD drug therapy, a change to dexamfetamine, the prospective description of the titration phase and a 12 month maintenance phase. Data on the use of dexamfetamine in routine clinical practice will be collected to describe how dexamfetamine is prescribed, titrated and used in the population of ADHD patients and how these factors influence the general intensity of ADHD and safety events. This study will collect real world data of dexamfetamine and compare descriptively the general intensity of ADHD according to ADHD classification and the impairment due to ADHD under therapy with dexamfetamine to the general intensity of ADHD according to ADHD classification and the impairment due to ADHD under the prior therapy with MPH. Furthermore the utilization of dexamfetamine will be assessed with regards to treatment persistence, compliance, proportion of patients discontinuing treatment and reason for discontinuation. Due to the fact that patients will be treated according to local medical practice it is possible that medication will be changed during the observation period.

Conditions

  • Attention Deficit Hyperactivity Disorder

Sponsors & Collaborators

  • University Hospital, Essen

    collaborator OTHER

  • Medice Arzneimittel Pütter GmbH & Co KG

    lead INDUSTRY

Principal Investigators

  • Michael Huss, Prof. Dr. · Child and Adolescent Psychiatry, University of Medicine, Mainz, Germany

Eligibility

Min Age
6 Years
Max Age
215 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2019-11-30
Completion
2019-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02801604 on ClinicalTrials.gov