E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
nervous exhaustion (neurasthenia) |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Symptoms and general pathology [C23] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029200 |
E.1.2 | Term | Nervous exhaustion |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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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 |
For demonstration of efficacy of Neurodoron the following primary endpoints are sequentially analysed:
1. Occurence and intensity of characteristic symptoms of nervous exhaustion, calculated as a sumscore
2. Perceived Stress, measured by the Perceived Stress Questionnaire
3. General health status, measured by short form health survey SF-36 |
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E.2.2 | Secondary objectives of the trial |
1. Clinically relevant reduction in exhaustion, measured by the Tedium Measure according to Pines/Aronson/Kafry
2. Time until onset of significant improvement as noted by the patient (reduction of characteristic symptoms)
3. Number of patients showing improvement of ≥50% (measured by means of sumscore)
4. Number of dropouts because of lack of efficacy and/or adverse events
5. Number, type and characeristics of adverse and serious adverse events
6. Changes in laboratory values compared to baseline
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Informed consent
2. At least 18 years of age
3. Confirmed diagnosis of nervous exhaustion according to the definition for neurasthenia as laid down in the WHO-criteria for research
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E.4 | Principal exclusion criteria |
1. Known hypersensitivity against wheat starch
2. Organic disease responsible for exhaustion
3. Neuro-psychiatric disease causing exhaustion
4. Presumed major depression, defined by BDI-II (Beck Depression Inventary) ≥29
5. Presumed major panic disorder or generalised anxiety disorder defined by GAD-7-score ≥16
6. Concomitant therapy interfering with IMP
7. Commitment to an institution because of official or judicial order
8. Pregnancy, lactation |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy of treatment is sequentially analysed by reduction of characteristic exhaustion symptoms (sumscore), perceived stress (Perceived Stress Questionnaire according to Fliege et al.), general health status (SF-36)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline, after 2 weeks and after 6 weeks of treatment |
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E.5.2 | Secondary end point(s) |
Tedium Measure according to Pines/Aronson/Kafry, time until onset of treatment effect noted by the patient (reduction of characteristic symptoms), number of patients showing improvement ≥50% (measured by means of sumscore), number of dropouts due to lack of efficacy, number of dropouts due to adverse events, number and type and characteristics of adverse and serious adverse events, type and frequency of clinically relevant laboratory changes compared to baseline
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline, after 2 weeks and after 6 weeks of treatment |
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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 | Yes |
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 | Yes |
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.8.5 | 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 | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
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 | 12 |
E.8.9.2 | In all countries concerned by the trial days | 0 |