E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Brain damage of any original cause, such as strokes, trauma, birth injury, post-viral infection. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10056389 |
E.1.2 | Term | Brain damage |
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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 optimise the treatment regime for patients and physicians who seek advice from Dr Clauss or ReGen Therapeutics PLC concerning a trial of zolpidem therapy for their relative or patient.
[Please note that experience of 200 patients in South Africa has found that the most severely damaged patients sometimes need higher doses of 30 mg per day when the usual sedative dose in Europe is 10mg. They do not exhibit much sedation. It is not known why they appear to be less sensitive than others. The resubmission the protocol includes extra information on the safety of zolpidem, which has been taken in overdose at 40 to 60 times normal doses without significant sequelae.] |
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E.2.2 | Secondary objectives of the trial |
• To identify clinically relevant differences in patterns in response. • To monitor safety of continuous exposure to zolpidem. • To explore the value of SPECT scans in measuring the cerebral metabolic response and by comparison with clinical findings to improve their diagnostic and prognostic value.
The potential advantages to ReGen Therapeutics are that • Future investigators may be identified and who will have learned from this survey how to document the required information. • Patients may be found who are known responders • The value of SPECT scanning may be explored. It might detect improvement when the clinical response is doubtful. TIt may document baseline extent of the damage which could help to better define the rate and duration of future improvement.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion Criteria Male or female patients of 12 or more years who have stable deficits of motor or cognitive function due to brain damage of any cause that was sustained at least 4 months beforehand.
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E.4 | Principal exclusion criteria |
Exclusion Criteria 1. Objection to the study by patients or patients’ families or medical practitioners. 2. Patients who are known not to tolerate zolpidem 3. Patients less than 12 years old 4. Pregnant women
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E.5 End points |
E.5.1 | Primary end point(s) |
This is more like an open-ended survey than a classic pharmaceutical clinical trial partly because there will be no designated number of subjects or formal statistical analysis. However proportions of responders vs non-responders will be calculated and patterns of responses will be sought both in clinical symptoms and signs and in SPECT scans if enough scans are done. |
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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 | Yes |
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 | 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 100 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |