Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-05 @ 11:35 AM
Study NCT ID:
NCT02801604
Status:
COMPLETED
Last Update Posted:
2020-09-02
First Post:
2016-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Attentin® in Children and Adolescents With ADHD - A Non-interventional Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-31', 'studyFirstSubmitDate': '2016-06-02', 'studyFirstSubmitQcDate': '2016-06-13', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ADHD classification', 'timeFrame': 'baseline until 1st follow-up visit after 6 months', 'description': 'change from baseline under MPH therapy to the 1st follow-up visit after 6 months under dexamfetamine, assessment by ADHD Rating Scale IV'}], 'secondaryOutcomes': [{'measure': 'ADHD classification subgroup: Age', 'timeFrame': 'baseline until 1st follow-up visit after 6 months', 'description': 'change from baseline to 1st follow-up in subgroup of age in years'}, {'measure': 'ADHD classification subgroup: Dose under MPH therapy', 'timeFrame': 'baseline until 1st follow-up visit after 6 months', 'description': 'change from baseline to 1st follow-up in subgroup of MPH dose in mg'}, {'measure': 'ADHD classification subgroup: Dose under dexamfetamine therapy', 'timeFrame': 'baseline until 1st follow-up visit after 6 months', 'description': 'change from baseline to 1st follow-up in subgroup of dexamfetamine dose in mg'}, {'measure': 'ADHD classification subgroup: Baseline ADHD classification', 'timeFrame': 'baseline until 1st follow-up visit after 6 months', 'description': 'change from baseline to 1st follow-up in subgroup baseline ADHD classification, assessment by ADHD Rating Scale IV'}, {'measure': 'Dose-response relationship between dose under dexamfetamine and ADHD classification at 1st follow-up', 'timeFrame': 'at 1st follow-up visit, 6 months after baseline'}, {'measure': 'ADHD classification change from baseline to titration and from baseline to 2nd follow-up after 1 year under dexamfetamine', 'timeFrame': 'baseline until 2nd follow-up visit after 1 year of examination', 'description': 'Assessment by ADHD Rating Scale IV'}, {'measure': 'Subscales hyperactivity/impulsivity', 'timeFrame': 'baseline until 2nd follow-up visit after 1 year of examination', 'description': 'Assessment by ADHD Rating Scale IV'}, {'measure': 'Subscales inattention', 'timeFrame': 'baseline until 2nd follow-up visit after 1 year of examination', 'description': 'Assessment by ADHD Rating Scale IV'}, {'measure': 'Response rate, relative reduction in ADHD classification from baseline to 1st follow-up of 30% or more', 'timeFrame': 'baseline until1st follow-up visit after 6 months'}, {'measure': "Overall impairment of the patient's everyday life and disability due to ADHD concerning home life", 'timeFrame': 'baseline until 2nd follow-up visit after 1 year of examination', 'description': 'Assessment for home life'}, {'measure': "Overall impairment of the patient's everyday life and disability due to ADHD concerning friendships", 'timeFrame': 'baseline until 2nd follow-up visit after 1 year of examination', 'description': 'Assessment for friendships'}, {'measure': "Overall impairment of the patient's everyday life and disability due to ADHD concerning classroom learning", 'timeFrame': 'baseline until 2nd follow-up visit after 1 year of examination', 'description': 'Assessment for classroom learning'}, {'measure': "Overall impairment of the patient's everyday life and disability due to ADHD concerning leisure activities", 'timeFrame': 'baseline until 2nd follow-up visit after 1 year of examination', 'description': 'Assessment for leisure activities'}, {'measure': 'Compliance of last MPH intake', 'timeFrame': 'baseline', 'description': 'estimated in per cent'}, {'measure': 'Compliance of last ADHD medication intake (other than MPH)', 'timeFrame': 'baseline', 'description': 'estimated in per cent'}, {'measure': 'Compliance of dexamfetamine intake', 'timeFrame': 'titration until 2nd follow-up visit after 1 year of examination', 'description': 'estimated in per cent'}, {'measure': 'Adverse Drug Reactions under ADHD medication, assessment of blood pressure in mmHg', 'timeFrame': 'baseline until 2nd follow-up visit after 1 year of examination', 'description': 'Assessment of vital parameter: blood pressure in mmHg'}, {'measure': 'Adverse Drug Reactions under ADHD medication, assessment of pulse in beats/min', 'timeFrame': 'baseline until 2nd follow-up visit after 1 year of examination', 'description': 'Assessment of vital parameter: pulse in beats/min'}, {'measure': 'Adverse Drug Reactions under ADHD medication, assessment of weight in kg', 'timeFrame': 'baseline until 2nd follow-up visit after 1 year of examination', 'description': 'Assessment of vital parameter: weight in kg'}, {'measure': 'Adverse Drug Reactions under ADHD medication, assessment of height in cm', 'timeFrame': 'baseline until 2nd follow-up visit after 1 year of examination', 'description': 'Assessment of vital parameter: height in cm'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': '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.\n\nIt 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '215 Months', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children and adolescents (Age ≥ 6 to 17.11 years) with ADHD, who were treated with methylphenidate (MPH) in the past and, when response to previous MPH treatment is considered clinically inadequate, will be treated with dexamfetamine in this non-interventional study. ADHD was classified according to a classification system of the DSM or ICD and the patient should have no contraindication against dexamfetamine.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 6 to 17.11 years\n* Current MPH therapy insufficient\n* ADHD was classified according to a validated classification system (e.g. DSM or ICD-10)\n* No contraindication against dexamfetamine\n\nExclusion Criteria:\n\n* Contraindication against dexamfetamine'}, 'identificationModule': {'nctId': 'NCT02801604', 'acronym': 'Attention', 'briefTitle': 'Attentin® in Children and Adolescents With ADHD - A Non-interventional Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medice Arzneimittel Pütter GmbH & Co KG'}, 'officialTitle': 'Attentin® in Children and Adolescents With ADHD - A Non-interventional Study', 'orgStudyIdInfo': {'id': 'Attention'}}, 'contactsLocationsModule': {'locations': [{'city': 'Mainz', 'country': 'Germany', 'facility': 'Child and Adolescent Psychiatry, University of Medicine', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}], 'overallOfficials': [{'name': 'Michael Huss, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Child and Adolescent Psychiatry, University of Medicine, Mainz, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medice Arzneimittel Pütter GmbH & Co KG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University Hospital, Essen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}