E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Not possible to specify |
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 primary objective is to determine whether neuroinflammation is present in subjects who have been exposed to chronic repetitive head injury during Muay Thai boxing, using [11C]-PK11195 PET. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to determine if there is a correlation between [11C]-PK11195 binding and: (1) the degree of cognitive deficits, as measured by neuropsychological tests, (2) white matter integrity, as measured by DTI, (3) regional cerebral blood flow as measured by ASL-MRI, and (4) serum proteins indicative of inflammation (e.g. C-reactive protein, IL-6). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All subjects:
-Age above 18 and below 50 years
-Male sex
-Written informed consent for participation
Boxers only:
-Minimum amount of 20 competitive bouts in Muay Thai boxing with rank A or B
-Minimum amount of 3 training sessions per week
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E.4 | Principal exclusion criteria |
All subjects:
-The use of benzodiazepines.
-The use of anticoagulants or having coagulation disorder.
-Use of somatic medication that may affect the immune system.
-Use of any investigational drug.
-Current or recent (<1 year) alcohol or substance abuse.
-Current or recent (<4 weeks) infectious or inflammatory disease.
-Current systemic disease.
-Major metabolic disease.
-Somatic, organic or neurological disorder (other than mTBI for patients).
-Participation in a scientific research study (<1 year) involving radiation.
-Claustrophobia.
-Presence of materials in the body that can be magnetized.
-Sustained (mild) traumatic brain injury within last 3 months.
For healthy volunteers only:
-Presence of infection of inflammation.
-(History of) Participation in contact sports, such as boxing, Muay Thai boxing, rugby, American football, etc. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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.8.3 |
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
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |