E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Attention Deficit Hyperactivity Disorder |
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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 |
To characterize the impact of genetic, environmental (e.g. smoking, concomitant use of drugs, narcotics, alcohol) and other factors such as gender, age, body weight and types of addiction on the inter- and intra-individual variability of plasma concentrations of MPH, its enantiomers and metabolites, and on dose requirement in adults with ADHD and comorbid SUD. |
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E.2.2 | Secondary objectives of the trial |
To explore the potential of a metabolomics approach using high resolution mass spectrometry (LC-HRMS) for simultaneous analysis of multiple drugs, metabolites and biomarkers in plasma.
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
EMPHAS IB SUBSTUDY (Evaluation of Methylphenidate (MPH) in adults with ADHD and SUD - clinical pharmacological study)
This is a substudy in the EMPHAS I study. 20 subjects in the study EMPHAS I will participate 4 times, 1-2 weeks apart, in order to evaluate intra-individual variability in plasma concentration.
Main objective: To characterize the impact of genetic, environmental (e.g. smoking, concomitant use of drugs, narcotics, alcohol) and other factors such as gender, age, body weight and types of addiction on the inter- and intra-individual variability of plasma concentrations of MPH, its enantiomers and metabolites, and on dose requirement in adults with ADHD and comorbid SUD.
Secondary objective: To explore the potential of a metabolomics approach using high resolution mass spectrometry (LC-HRMS) for simultaneous analysis of multiple drugs, metabolites and biomarkers in plasma. |
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E.3 | Principal inclusion criteria |
•Adults (18-64 years) treated with MPH, with a minimum duration of 14 days at Beroendecentrum Stockholm. •Diagnosed with ADHD according to the Diagnostic and Statistical Manual of Mental Diseases, DSM-IV or DSM-5. •Diagnosed with at least one non-nicotine substance use disorder according to the Diagnostic and Statistical Manual of Mental Diseases, DSM-IV or DSM-5. •Signed informed consent form indicating that they understood the purpose of and procedures required for the study and are willing to participate in the study •Patient is able to comply with the study visit schedule and willing and able to complete the protocol-specified assessments
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E.4 | Principal exclusion criteria |
No study-specific exclusion criteria |
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E.5 End points |
E.5.1 | Primary end point(s) |
•Plasma concentrations of MPH, its enantiomers, metabolites and concomitant drugs |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
2 bloodsamples will be collected Visit 1 to Visit 4 (one-two weeks interval) |
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E.5.2 | Secondary end point(s) |
•Genetic polymorphisms of candidate genes hypothesized to influence MPH effects for ADHD in adults with SUD and ADHD, treated with MPH
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Visit 1 Pharmacogenetic blood sample
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
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 | No |
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 | No |
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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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 | |