E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mental fatigue after traumatic brain injury or whip-lash injury |
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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 methylphenidate as measured by self assessment questionnaire, with focus on mental fatigue, recovery and concentration capacity in patients with mental fatigue who suffered traumatic brain injury or whip-lash injury. |
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E.2.2 | Secondary objectives of the trial |
Study effects of methylphenidate on objective neuropsychological tests with focus on information processing speed and attention in these same patients. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subjects who suffer from mental fatigue and pain due to a head trauma or a whip-lash trauma >12 months earlier. The persons are attended to by the Department of Neurology, SU/S, the Kungälv´s Pain Centre or the Multidisciplinary Pain Center, SU/Ö, Sahlgrenska University Hospital, SU/S. 2. Age 20 – 65. 3. Glasgow Outcome Scale (extended), moderate disability (~5) or better recovery. |
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E.4 | Principal exclusion criteria |
1. Significant co-morbidity. Persons, where pain is the main problem. Persons with pain of other genesis as well as pain prone persons or a high degree of somatisation. 2. Major depression (according to DSM IV) prior to the trauma. 3. Organic personality disorder or other organic CNS disorder. Women of child-bearing age who are not on contraceptives. Pregnant women, Alcohol or drug abuse. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint is to investigate the therapeutic effects of methylphenidate as measured by the self assessment questionnaire, with focus on the mental fatigue, recovery and concentration capacity in patients with mental fatigue who suffered a head trauma or a whip-lash trauma. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Each patient is his/her own control |
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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 | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
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
| |
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 |