SYF400c6b05021f48d9aebc7bd5d1175bf3Registry ID: 2023-507404-31-03|SuspendedPhase 2
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interventional
N/A
1 country
4
This clinical trial aims to investigate the potential underlying mechanisms of action of zolpidem in three groups of patients with disorders of consciousness (DoC), neurotypical volunteers representing the general population, and patients with partial/total acquired vision impairments as certain proportion of people in all these groups respond paradoxically to zolpidem. Paradoxical responses to zolpidem lead to recovery of consciousness in DoC patients and temporary recovery of vision in patients with vision impairments. Neurotypical volunteers with paradoxical responses also show inability to fall asleep, higher levels of concentration, increased agitation, etc. Therefore, the findings of this study could contribute to a better understanding of the mechanisms of action of zolpidem in paradoxical responders vs. non-paradoxical responders to zolpidem and can lead to improved personalised patient care.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
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October 14, 2024
Actual (reported)DoC patients: Consciousness level (Coma Recovery Scale-Revised – CRS-R); Neural complexity (high density electroencephalography – hdEEG); Phenomenological experiences (Free recall/interview, if the patient recovers functional communication after IMP/placebo administration)
Neurotypical volunteers: Alertness/sleepiness level (Karolinska Sleepiness Scale – KSS); Cognitive performance (Standardised neuropsychological tests); Neural complexity (high density electroencephalography – hdEEG); Phenomenological experiences (Free recall/interview)
Patients with vision impairments: Alertness/sleepiness level (Karolinska Sleepiness Scale – KSS); Cognitive performance (Standardised neuropsychological tests); Neural complexity (high density electroencephalography – hdEEG); Phenomenological experiences (Free recall/interview); Visual functions (ophthalmological testing by a neuro-ophthalmologist)
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Formulated product
MANNITOL
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CAPSULE
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MANNITOL
Named ingredient: Mannitol
View registry recordCentre Neurologique William Lennox
Ottignies, B-1340, Belgium
Hôpital du Valdor
Liège, 4020, Belgium
Hopital Erasme
Anderlecht, 1070, Belgium
Pr. Vincent Bonhomme
First Submitted
October 14, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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CHU De Liege
Liege, 4000, Belgium