Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443827
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-15
Brief Title:
Effect of Intravenous Amantadine Sulphate on Disorders of Consciousness
Sponsor:
Azienda Sanitaria dellAlto Adige
Organization:
Azienda Sanitaria dellAlto Adige
Study Overview
Official Title:
Effects of Intravenous Amantadine Sulphate on Brain Dynamics and Neurobehavioral Status in Patients With Disorders of Consciousness
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DOC-AMSUL
Brief Summary:
Double-blind placebo-controlled crossover within subjects study with an A-B-A-B treatment scheme to investigate the neuromodulatory effects of intravenous amantadine sulphate at a single daily dose of 200 mg in patients with disorders of consciousness unresponsive wakefulness syndrome and minimally conscious state by integrating traditional neurobehavioral assessment with spectral analysis of electrocortical activity derived from 64-channel electroencephalography EEG recordings
Detailed Description:
Research hypothesis Intravenous amantadine sulphate treatment 200 mg over five days improves consciousness defined as an increase in CRS-r score of at least 3 points and changes the band powers of the EEG in patients with disorder of consciousness admitted in a Neurorehabilitation Department
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None