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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2008-004827-44-GB |
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Date of registration:
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07/12/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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OPEN LABEL TRIAL OF ATOMOXETINE FOR ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN CHILDREN WITH SPECIAL EDUCATIONAL NEEDS - Atomoxetine-HSEN
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Scientific title:
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OPEN LABEL TRIAL OF ATOMOXETINE FOR ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN CHILDREN WITH SPECIAL EDUCATIONAL NEEDS - Atomoxetine-HSEN |
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Date of first enrolment:
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18/11/2008 |
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Target sample size:
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40 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004827-44 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Waiting period of 8 weeks before initiation of treatment
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Principal Inclusion Criteria
1. Children and adolescents of both genders, aged 7-18 years inclusive at the beginning of trial.
Children over 16 should be in full-time education and not expected to leave school within 6 months. Additionally children over 16 will be assessed for their capacity to give consent to participate in the trial using the Mental Capacity Tool (Children over 16 appendix). This tool was designed for use with young adults with intellectual disability, neurodevelopmental or other disorders that might impair their ability to give informed consent. Evidence of potential impairment in capacity includes the diagnosis of learning disability, IQ <70, significant deficits in adaptive functioning, or other signs or symptoms of mental disorder that might compromise capacity to give informed consent. The assessment establishes understanding, retention of information, use of information to make the decision and communication of the decision. These reflect the limbs of the 'capacity test' as defined in the Mental Capacity Act 2005.
We expect that the majority of the over 16 children would have difficulties in showing the necessary understanding in order to consent due to their special needs; in these cases a consultee will be appointed following the procedure described in the Children over 16 appendix.
2. Diagnosis of attention deficit hyperactivity disorder (ADHD)
3. Full-scale IQ 30-69 or age equivalent estimate
4. All participants have failed to respond to methylphenidate or presented with adverse effects that necessitated withdrawal from the study.
5. Their place of residence should be within catchment area.
6. Eligible participants must be in a stabel care situation: Parenting/care history will be reviewed during re-assessment:
a) Care in home
b) Respite Care
c) Residential school placement
7. Informed consent is obtained.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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. Children currently receiving atomoxetine will not be included.
2. Those who have received atomoxetine in the past, regardless of response, may be included, provided they did not demonstrate frank intolerance.
3. A clear-cut history of intolerance to atomoxetine or concomitant use of MAO inhibitor medication or narrow angle glaucoma represent absolute contradictions to the use of atomoxetine constitute exclusion to the trial.
4. Severe limitation of child’s mobility
5. Child has a dementing or degenerative disorder
6. The presence of poorly controlled or uncontrolled epilepsy
7. History of significant cardiovascular disease
8. Child has a diagnosis of a psychotic disorder or bipolar disorder
9. Child has severe obsessive-compulsive disorder severe enough to require special treatment.
10. Child is being treated with neuroleptic medication (children on neuleptics for other reasons must be withdrawn from medication for one month before baseline assessment)
11. Child is not on stimulant medication for at least one week
12. Child poses a significant risk of suicidal or homicidal behaviour
13. Children without a full-time school placement that is expected to continue for the next 4 months will not be eligible for the study.
14. Another child in the family and/or in the household currently enrolled in this study.
15. Children residing in a home without a telephone (land line or mobile)
16. There are ongoing child protection concerns
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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We will conduct a prospective, open-label pilot study of atomoxetine targeted toward symptoms of ADHD in children with learning disabilities and ADHD (Attention Deficit Hyperactivity Disorder).
MedDRA version: 9.1
Level: LLT
Classification code 10064104
Term: ADHD
MedDRA version: 9.1
Level: LLT
Classification code 10020658
Term: Hyperkinetic syndrome
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Intervention(s)
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Trade Name: Strattera 10mg
Pharmaceutical Form: Capsule, hard
Other descriptive name: Atomoxetine hydrocholoride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Trade Name: Strattera 18mg
Pharmaceutical Form: Capsule, hard
Other descriptive name: Atomexitine hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 18-
Trade Name: Strattera 25mg
Pharmaceutical Form: Capsule, hard
Other descriptive name: Atomexitine hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: Strattera 60mg
Pharmaceutical Form: Capsule, hard
Other descriptive name: Atomexitine hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Trade Name: Strattera 80mg
Pharmaceutical Form: Capsule, hard
Other descriptive name: Atomexitine hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
Trade Name: Strattera 40mg
Pharmaceutical Form: Capsule, hard
Other descriptive name: Atomexitine hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
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Primary Outcome(s)
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Main Objective: What is the efficacy of atomoxetine in reducing the symptoms of ADHD among children with moderate and severe learning disabilities and ADHD?
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Secondary Objective: What is the adverse effects profile associated with atomoxetine treatment amongst children with learning disabilities?
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Primary end point(s): The primary efficacy criteria are reduction in symptoms of hyperactive behaviour (overactivity, poor concentration and impulsivity) as rated by parents and teachers on the ADHD index of the short version of the Conners scale (CRS-S; Conners, 1989). Average baseline ratings taken prior to treatment will be compared to average ratings taken during Week 16.
The proportion of “responders” will be estimated using the following three definitions of a “responder”:
i) Decrease of symptom severity of 30% at least at week 16 compared to baseline scores on parent ratings on the ADHD index of the CRS-S.
ii) Decrease of symptom severity of 30% at least at week 16 compared to baseline scores on teacher ratings on the ADHD index of the CRS-S.
iii) Where a child is classified as a responder on the basis of both parent and teacher ratings on the ADHD index of the CRS-S as defined above.
Additionally, we will rate as ‘good responders’ participants with decrease of symptoms of 50% at least at the same measures as above.
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Secondary ID(s)
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R&D2008/083
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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