E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The effect of fluoxetine on brain excitability and muscle activation will be measured in chronic stroke patients (> 6 months after stroke). As secondary measures, also brain activation, phase-synchronization in the brain, and motor function will be studied. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10055221 |
E.1.2 | Term | Ischemic stroke |
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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 |
Primary objectives of the study are to investigate if fluoxetine influences brain excitability and muscle activation in such a way it could improve motor function. This objective will be measured by answering following hypotheses: Hypothesis 1: Long-term use of fluoxetine causes the excitability of the primary motor area of the brain to change. Hypothesis 2: Long-term administration of fluoxetine causes the muscle activation patterns to increase.
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E.2.2 | Secondary objectives of the trial |
Secondary objective of the study is to examine if fluoxetine causes the activation and communication of brain areas to change. In addition, the motor function will be measured to examine if the potential changes are large enough to cause the motor function to change. These objectives are tested by the following hypotheses: Hypothesis 3: Long-term use of fluoxetine modulates activation of areas of the brain during voluntary movement. Hypothesis 4: Long-term use of fluoxetine increases the communication between areas of the brain. Hypothesis 5: Long-term administration of fluoxetine causes the motor function to change. Also the correlation between all outcome measures will be analyzed, to understand the linking between the different parameters.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
First ever ischemic cortical/subcortical ischemic stroke, confirmed by CT or MRI; more than 6 months after stroke; age > 18 |
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E.4 | Principal exclusion criteria |
Patients suffering from another neurological disease; uncompensated hemineglect or cognitive disabilities; epilepsy, or first epileptic insult post stroke; patients with first grade relatives suffering from epilepsy; pregnancy; pacemaker; pathological heart rhythms disorders; use of antidepressants. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Knowledge if long-term administration of fluoxetine changes brain excitability and muscle activation in chronic stroke patients, and if it is possible that fluoxetine promotes motor function in stroke patients. |
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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 | 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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
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 | Information not present in EudraCT |
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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |