E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Montelukast is indicated for prophylaxis and chronic treatment of asthma and for the relief of symptoms of seasonal allergic rhinitis. We investigate side effects of Montelukast, specifically potential effects on brain activity. |
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E.1.1.1 | Medical condition in easily understood language |
Montelukast is used for treatment of asthma and allergic rhinitis. We examine the effect of Montelukast on brain activity. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
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 |
We want to examine effects of Montelukast on brain activity. |
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E.2.2 | Secondary objectives of the trial |
We want to correlate CNS effects with cognitive or psychiatric side effects under treatment with Montelukast. We want to predict cognitive or psychiatric side effects under treatment with Montelukast by baseline EEG-characteristics. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
We recruit 24 patients starting a monotherapy or an add-on therapy with Montelukast because of asthma or allergic rhinitis. Patients should be between 18 and 80 years old and be able to give informed consent. |
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E.4 | Principal exclusion criteria |
According to the criteria for pharmaco-EEG studies (Jobert et al., 2012), all participants with a history of • excessive, regular consumption of alcohol (more than 3 units/day for women or 4 units/day for men; 1 unit is 1/4 l of vine or 1/2 l of beer) tobacco (more than 5 cigarettes per day), or caffeine (more than 4 cups per day) • a rapidly progressive neurological disorder (e.g. dementia, parkinson, multiple sclerosis), • a psychiatric history, • or substance abuse will be excluded. We exclude women with child-bearing potential. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Differences in EEG characteristics between baseline (before treatment) and follow up (after 8 weeks of treatment).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After study completion (after 1 year) on whole sample. |
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E.5.2 | Secondary end point(s) |
2. Correlation of changes in EEG characteristics and neuropsychological scales from baseline to follow up. 3. Predictive value of EEG characteristics at baseline for changes on neuropsychological scales. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After study completion (after 1 year) on whole 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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
We want to assess whether it is possible to detect neural changes during medication with Montelukast in the EEG. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |