Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-02-25 @ 8:48 PM
Study NCT ID:
NCT02801604
Status:
COMPLETED
Last Update Posted:
2020-09-02
First Post:
2016-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Attentin® in Children and Adolescents With ADHD - A Non-interventional Study
Sponsor:
Medice Arzneimittel Pütter GmbH & Co KG
Organization:
Study Overview
Official Title:
Attentin® in Children and Adolescents With ADHD - A Non-interventional Study
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Attention
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: