E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
hormonal deficiency after traumatic-brain- injury (TBI) or subarachnoidal haemorrhage (SAH) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011198 |
E.1.2 | Term | Cortisol decreased |
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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 |
To evaluate the interindividual difference (Δ) of cognitive function in patients with or without hydrocortisone treatment after 7 and 14 days of treatment |
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E.2.2 | Secondary objectives of the trial |
To evaluate the intraindividual difference (Δ) of cognitive function in patients with or without hydrocortisone treatment after 7 and 14 days of treatment |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Adult patients (male and female) between 18 and 75 years 2) 1 -12 month after TBI or SAH before prescreening 3) Cortisol level 100-180 ng/ml after stimulation with ACTH (250 microgramm according to ACTH low-dose short test) 4) Written informed consent by patient or a legally accepted representative
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E.4 | Principal exclusion criteria |
1. Pregnancy and lactation period (during study treatment) 2. Concomitant or previous high-dose therapy with glucocorticoides; previous treatment with glucocorticoides will be accepted, if it has been low dose (i.e. lower than the Cushing threshold) and has been stopped at least 3 month before study participation. 3. Suspected or known hypersensitivity to hydrocortisone or any of its components 4. Albumine ≤ 2,5 g/dl 5. Suspected or known drug or alcohol abuse 6. Planned treatment for thyroid dysfunction or a planned change in established thyroid treatment 7. Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion. 8. Participation in another clinical trial with investigational new drugs 9. Severe medical or psychiatric disease 10. Change of dosage of any other drug which might influence the corticotrope axis or cognitive function (e.g. antidepressive treatment) during the last 3 weeks 11. Oral contraceptives 12. Severe disturbances in articulation, visual faculty or hearing 13. Any elective surgery or medical treatment planned in the observation period 14. Intensive Care treatment
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E.5 End points |
E.5.1 | Primary end point(s) |
Changes (Δ) in score of Alertness test (TAP) |
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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 | 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) | 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 | 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 | No |
E.8.1.6 | Cross over | Yes |
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.8.3 |
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 | 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
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End of the trial is day 14 or optional day 21. If the pat. drops out before a final visit should be done |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 19 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
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 |