E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Epilepsy and comorbid ADHD/ADD |
Epilepsi og komorbid ADHD/ADD |
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E.1.1.1 | Medical condition in easily understood language |
Epilepsy and ADHD/ADD (attention deficit (hyperactivity) disorder) |
Epilepsi og ADHD/ADD (attention deficit hyperactivity disorder med eller uten hyperaktivitet) |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective of the trial is to evaluate if standardized and computerized workingmemory-training is as effective as traditional treatment (i.e stimulant medication/Methyphenidate) against ADHD symptoms in children and adolecents with attention deficits and epilepsy |
Primært endepunkt er å evaluere om standarisert arbeidsminnetrening med dataspill er like effektiv behandling som tradisjonell ADHD-behandling (sentralstimulerende medisiner/metylfenidat) mot ADHD -symptomer hos barn og unge med epilepsi og ADHD |
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E.2.2 | Secondary objectives of the trial |
To assess if WMT improve executive function compared to baseline and to medicated group 12 weeks after inclusion.
To assess if WMT influence on seizure-frequency and EEG-patterns compared to baseline
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se over |
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E.2.3 | Trial contains a sub-study | No |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
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E.3 | Principal inclusion criteria |
9-15 years, known epilepsy, ADHD/ADD according to the current diagnostic criteria, boys and girls
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9-15 år, kjent epilepsi ADHD/ADD i hht gjeldende diagnosekriterer, gutter og jenter |
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E.4 | Principal exclusion criteria |
Known depressive reaction/PTSD, more than two anti-epileptic drugs, diagnosis of moderate and severe mental retardation (F.71-F.79 or IQ below 55), medication under review, unstable seizure pattern, unstable life situation, contraindications for methylphenidate. |
Kjent depressiv reaksjon/PTSD, mer enn to antiepileptika, diagnose på moderat og alvorlig PU, medikamentomlegging, ustabil livssituasjon,ustabil anfallssituasjon, kontraindikasjoner for bruk av metylfenidat |
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E.5 End points |
E.5.1 | Primary end point(s) |
Improvement in workingmemory-tests 12 weeks from baseline in subjects receiving WM-training. The assessed improvement should be at least equal to the improvements in the medicated group. |
Bedring på arbeidsminnetester 12 uker etter baseline hos pasienter som har fått arbeidsminnetrening. Bedringen skal være minst like god som den i medisinert gruppe. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Timepoint for all endpoints would be 10-12 weeks after inclusion. |
Tidspunkt for evaluering av endepunkt vil være mellom 10 til 12 uker etter inklusjon. |
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E.5.2 | Secondary end point(s) |
Improvements in parents and teachers questionnaire: BRIEF (Behavior Rating Inventory of executive function) and ADHD-rating-scale - compared to baseline.
Does WM-training induce changes in quantified EEG (spike-activity and/or changes in theta/beta ratio) compared to baseline? |
se over |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Timepoint of this evaluation will be the same as above; between 10-12 weeks after inclusion. |
se over |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
RoboMemo |
Computerized Working Memory Training "RoboMemo" by CogMed/Pearson Group |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The last visit of the last subject is estimated to be in march 2017. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |