E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
operated chronic subdural hematoma |
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E.1.1.1 | Medical condition in easily understood language |
operated chronic subdural hematoma |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049163 |
E.1.2 | Term | Chronic subdural hematoma |
E.1.2 | System Organ Class | 100000004863 |
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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 demonstrate that dexamethson reduces the reoperation rate for 50% within 12 weeks after hematoma evacuation |
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E.2.2 | Secondary objectives of the trial |
To evaluate that dexamethason improves clinical outcome during a period of 12 weeks after surgery, as measured by the Markwalder score
To evaluate if dexamethason provokes a faster clinical improvement postoperative
To evaluate the impact of dexamethason on the thickness of the hematoma, its membranes and mass demanding effect (midline-shift).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Males and females over the age of 25
All patients, who are operated for chronic subdural hematoma
Written informed consent to participate in the study must be obtained from the patient or a legal representative prior to initiation of any study-mandated procedure and randomization
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E.4 | Principal exclusion criteria |
Pregnancy and nursing
Diabetes
Hypertension > 180mmHg syst. despite medicamentous therapy
Hypersensitivity of dexamethason
Peptic ulceration
Acute systemic infection
Parasitic infections
Patients for whom it is known, at the time of screening, that certain follow up, protocol-mandated imaging assessments will not be feasible
Patients unlikely to comply with the protocol (e.g., unable to return for-follow up visits).
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E.5 End points |
E.5.1 | Primary end point(s) |
Reoperation between 48 hours and 12 weeks after the primal operation |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Reoperation between 48 hours and 12 weeks after the primal operation |
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E.5.2 | Secondary end point(s) |
Clinical improvement measured by the Markwalder-score
Reduction of the thickness of hematoma or midline-shift
Reduction of the membranes, if present
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
from time of operation until 12 weeks postoperative
in case of reoperation until 24 weeks after the initial procedure |
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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 | Yes |
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) | Yes |
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 | 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 | 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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 | 7 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 30 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 30 |