Clinical Trial Results:
OPEN LABEL TRIAL OF ATOMOXETINE FOR ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN CHILDREN WITH SPECIAL EDUCATIONAL NEEDS
Summary
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EudraCT number |
2008-004827-44 |
Trial protocol |
GB |
Global end of trial date |
22 Mar 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
24 Aug 2019
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First version publication date |
24 Aug 2019
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
ATOM
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Additional study identifiers
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ISRCTN number |
ISRCTN25691213 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
King's College London
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Sponsor organisation address |
The Strand, London, United Kingdom, WC2R 2LS
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Public contact |
Professor Emily Simonoff, King's College London, +44 02078485312, emily.simonoff@kcl.ac.uk
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Scientific contact |
Professor Emily Simonoff, King's College London, +44 02078485312, emily.simonoff@kcl.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
22 Mar 2013
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
22 Mar 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
22 Mar 2013
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
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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Protection of trial subjects |
Following determination of eligibility, informed consent will be obtained from at least one parent with parental responsibility or legal guardian. Children and young people will be given developmentally appropriate information about the disorder, its treatment and the trial. Only exceptionally will children be enrolled where there is disagreement among the parents regarding consent to participate.
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Background therapy |
None | ||
Evidence for comparator |
not applicable | ||
Actual start date of recruitment |
11 Nov 2009
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 11
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Worldwide total number of subjects |
11
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EEA total number of subjects |
11
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
6
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Adolescents (12-17 years) |
5
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants were recruited at one site in the UK between 2009 and 2013 | |||||||||
Pre-assignment
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Screening details |
1 Aged 7 - 15 years, 2 Diagnosis of ADHD 3 Full-scale intelligence quotient (IQ) 30 - 69 or age equivalent estimate 4 Did not respond to methylphenidate either at high dose or because dose limited by unacceptable adverse effects 5 Child in stable care situation 6 Child regularly attending school (more than 75% of last school term) | |||||||||
Pre-assignment period milestones
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Number of subjects started |
11 | |||||||||
Number of subjects completed |
11 | |||||||||
Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Blinding implementation details |
Participants will be randomized immediate start atomoxetine or delayed start by 8 weeks.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Immediate | |||||||||
Arm description |
Immediate | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Atomoxetine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Active treatment: Participants randomised to immediate treatment . All participants dosing regime as below:-
Week 1 - Strattera 0.5 mg/kg/day (starting dose) during the first week,
Week 2 – Strattera 0.8 mg/kg/day (low dose)
Week 3 to 16 - 1.2 mg/kg/day (standard dose)
or
Week 8 to 16 - Subjects showing less than “much improvement” on the CGI—Improvement (CGI-I) scale at the end of week 8, AND experiencing mild or no adverse effects, may have a further dose increase to 1.4 mg/kg/day (high dose).
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Arm title
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Delayed Treatment | |||||||||
Arm description |
Active treatment: Participants randomised to delayed (8 weeks treatment). | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Atomoxetine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Active treatment: Participants randomised to treatment delayed for 8 weeks . All participants dosing regime as below:-
Week 1 - Strattera 0.5 mg/kg/day (starting dose) during the first week,
Week 2 – Strattera 0.8 mg/kg/day (low dose)
Week 3 to 16 - 1.2 mg/kg/day (standard dose)
or
Week 8 to 16 - Subjects showing less than “much improvement” on the CGI—Improvement (CGI-I) scale at the end of week 8, AND experiencing mild or no adverse effects, may have a further dose increase to 1.4 mg/kg/day (high dose).
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Immediate
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Reporting group description |
Immediate | ||
Reporting group title |
Delayed Treatment
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Reporting group description |
Active treatment: Participants randomised to delayed (8 weeks treatment). |
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End point title |
Primary Efficacy Endpoint [1] | |||||||||
End point description |
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
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End point type |
Primary
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End point timeframe |
0-16 weeks
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Due to insufficient recruitment, it was not possible to analyse the data obtained. However no safety concerns were raised. |
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No statistical analyses for this end point |
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End point title |
Secondary Efficacy Parameters | |||||||||
End point description |
Secondary efficacy outcome variables:
1.Conners’ hyperactivity scale (parent and teacher)
2.Clinical Global Impressions Scale (improvement)
3.Parent Aberrant Behaviour Scale
4.Teacher Aberrant Behaviour Scale
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End point type |
Secondary
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End point timeframe |
0-16 weeks
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Duraton of Trial
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.1
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Reporting groups
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Reporting group title |
Immediate Treatment
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Reporting group description |
Participants introduced to atomoxetine straight after the reassessment. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Delayed Treatment
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Reporting group description |
introduced to atomoxetine 8 weeks after reassessment. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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12 Jul 2010 |
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 deficity 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.
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31 Jan 2011 |
1) To change the period off-psychotropic medication from 3 months to 1 month in order for the children to have quicker access to the trial.
2) To clarify that children who ·use to be stimulants should be off them for at least a
week. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
This trial was terminated early due to inability to recruit eligible participants, therefore insufficient data was obtained to perform robust analyses or meet the prirmary endpoints. No safety concerns were raised. |