E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mental fatigue after traumatic brain injury |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
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 |
Investigate the therapeutic effects of OSU 6162 as measured by self assessment questionnaire, with focus on mental fatigue, recovery and concentration capacity in patients with mental fatigue who suffered a traumatic brain injury. |
|
E.2.2 | Secondary objectives of the trial |
To study the effects of OSU 6162 on objective measures such as neuropsychological testing and functional magnetic resonance imaging, with focus on mental fatigue, and cognitive capacity in patients with mental fatigue who suffered a traumatic brain injury. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients who > 12 months earlier suffered a traumatic brain injury are attended to the Department of Neurorehabilitation, Northern University Hospital. 2. Age 18-65. Glasgow Outcome Scale (extended), moderate disability (appr 5) or better recovery. |
|
E.4 | Principal exclusion criteria |
1. Significant co-morbidity including psychiatric or neurological disorder. 2. Women of childbearing potential not on contraceptives. 3. Pregnant women. 4. Alcohol or drug abuse. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Investigate the therapeutic effects of OSU 6162 as measured by self assessment questionnaire, with focus on mental fatigue, recovery and concentration capacity in patients with mental fatigue who suffered a traumatic brain injury. |
|
E.5.2 | Secondary end point(s) |
To study the effects of OSU 6162 on objective measures such as neuropsychological testing and functional magnetic resonance imaging, with focus on mental fatigue, and cognitive capacity in patients with mental fatigue who suffered a traumatic brain injury. |
|
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 | Yes |
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) | Yes |
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.8.2.4 | 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 | 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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |