E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The objective of this study is to examine the effect of a single dose of fluoxetine and of movement observation on cortical activity in chronic stroke patients (>6 months after stroke). As secondary objectives, the effect of fluoxetine on motor function and muscle activity will be measured. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
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 |
The main objective of this trial is to examine the influence of a single dose of fluoxetine and of movement observation on cortical activity. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are: 1. to examine the effect of fluoxetine on motor function 2. to examine the influence of fluoxetine on muscle activation patterns 3. to examine the correlation between brain activity and muscle activation patterns; 4. to examine the correlation between brain activity and motor outcome; 5. to examine the correlation between muscle activity and motor outcome;
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
First ever ischemic stroke, confirmed with a CT-scan or a MRI-scan Unilateral cortical and/or subcortical stroke Stroke more than 6 months ago Some motor dysfunction of the arm/hand but some motor function left (MRC between 2 and 4) Age between 18 and 80 years Obtained informed consent
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E.4 | Principal exclusion criteria |
Other (pre-existing) neurological diseases (e.g. epilepsy, tumor, paralysis) Known allergy to SSRI’s Use of anti-depressants (tricyclic antidepressants, serotonin reuptake inhibitors, MAO-inhibitors) Autism spectrum disorders, PDD, schizophrenia (or history of schizophrenia) Unstable medical health situation (cardiovascular and/or neurological) Uncompensated hemineglect or cognitive disabilities, resulting in misunderstanding or incapability of executing instructions given Uncorrected visual problems, i.e. not able to observe the movie on the screen Pregnancy Severe uncontrolled medical conditions Known alcoholism or drug abuse Known elevated brain pressure (hydrocephalus)
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E.5 End points |
E.5.1 | Primary end point(s) |
Knowledge whether a single dose of fluoxetine is capable of changing brain activity and whether this change has influence on motor function. |
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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 | Information not present in EudraCT |
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 | No |
E.8.1.6 | Cross over | Yes |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |