Brain damage of any original cause, such as strokes, trauma, birth injury, post-viral infection. MedDRA version: 9.1 Level: LLT Classification code 10056389 Term: Brain damage
Conditions
Interventions
Trade Name: Stilnoct®
Pharmaceutical Form: Tablet
INN or Proposed INN: ZOLPIDEM
CAS Number: 82626480
Current Sponsor code: None (not sponsor's product)
Concentration unit: mg milligram(s)
Concentratio
Sponsors
Regen Therapeutics PLC
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • 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.];Secondary Objective: • 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. ;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. | — |
Countries
United Kingdom
Outcome results
None listed