E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Long-term pain and mental fatigue after traumatic brain injury and work rehabilitation. |
Långvarig värk och mental trötthet/hjärntrötthet efter skallskada och arbetsrehabilitering. |
|
E.1.1.1 | Medical condition in easily understood language |
Long-term pain and mental fatigue after traumatic brain injury and work rehabilitation. |
Långvarig värk och mental trötthet/hjärntrötthet efter skallskada och arbetsrehabilitering. |
|
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 |
The study will be conducted in order to investigate whether methylphenidate improves pain and mental fatigue to that degree that the traumatic brain injury victim can more easily perform work rehabilitation. |
Undersöka om behandling medmetylfenidat medför arbetsträning i större omfattning hos personer med långvarig värk och mental trötthet efter skallskada |
|
E.2.2 | Secondary objectives of the trial |
Not applicable. |
Inte applicerbart. |
|
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 >12 months earlier. The persons are attended to by the Department of Neurology, SU/S. 2. Age 20 – 65. 3. Glasgow Outcome Scale (extended), moderate disability (~5) or better recovery. |
|
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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
to investigate the therapeutic effects of methylphenidate as measured by the self assessment questionnaire (MFS), with focus on mental fatigue and recovery, as specified in Protocol, and work capacity after 6 and 12 months, respectively. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Three, six and twelve months, respectively. |
|
E.5.2 | Secondary end point(s) |
Results from the neuropsychological tests, with focus on tests measuring information processing speed, effects on health economy and work capacity as specified in Protocol. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Three, six and twelve months, respectively. |
|
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 | 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) | 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 | 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.8.2.4 | Number of treatment arms in the trial | 3 |
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
|
When work rehabilitation program is finished. |
|
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 | |