E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Traumatic brain injury (TBI), cerebral haemorrhage (ICH), subarachnoid haemorrhage (SAH) and cerebral commotio. |
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E.1.1.1 | Medical condition in easily understood language |
Traumatic brain injury, cerebral bleeding, subarachnoid bleeding and concussion of the brain |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10070976 |
E.1.2 | Term | Craniocerebral injury |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042320 |
E.1.2 | Term | Subarachnoid hemorrhage |
E.1.2 | System Organ Class | 100000004852 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060690 |
E.1.2 | Term | Traumatic brain injury |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022754 |
E.1.2 | Term | Intracerebral hemorrhage |
E.1.2 | System Organ Class | 100000004852 |
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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 primary objective is to study if tau is increased in the brain compared to the normal population and where in the brain the uptake occures. |
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E.2.2 | Secondary objectives of the trial |
To correlate the uptake of tau in the brain with levels of tau in the blood, and is it possible to follow tau in the brain with blood samples? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- The subject/patient has given his written consent to participate in the study. Study population A-C (patients with TBI, ICH or SAH): - Cared for in the intensive care unit NIVA with one of the diagnoses traumatic brain injury (TBI), intracerebral haemorrhage (ICH) or subarachnoid haemorrhage (SAH). During the care period, relatives have been informed and did not object to participation. - Age 18-60 years. -The patient is judged by the investigator to be clinically stable enough to pass the examination with PET, and understand the study information
Study population D (athletes): - Athletes age 18-40 years - The athlete has suffered from at least one previous concussion in sports and has persistent symptoms. - The athlete must have had symptoms (post-emotional syndrome) for at least 6 months after the last concussion.
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E.4 | Principal exclusion criteria |
- Claustrophobia - Pregnancy, breast-feeding or planned pregnancy. -- Mental inability, reluctance or language difficulties that make it difficult to understand the meaning of participating in the study. -- Treatment or illness which, according to the examiner, may affect the treatment or the study result. -- Participates in or has recently participated in a clinical trial in the last 6 months.
- Pregnancy, breast-feeding or planned pregnancy.
- Mental inability, reluctance or language difficulties that make it difficult to understand the meaning of participating in the study.
- Treatment or illness which, according to the examiner, may affect the treatment or the study result.
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E.5 End points |
E.5.1 | Primary end point(s) |
Uptake of the PETtracer measured at PET examination. |
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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) |
Uptake of the PET tracer at PET examination compared with levels of tau in blood. |
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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 | Yes |
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 | 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 | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |