Active — Not RecruitingPhase 2

Effect of Intravenous Amantadine Sulphate on Disorders of Consciousness

Italy18 participantsStarted 2018-09-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Adults with disorders of consciousness due to acquired brain injury classified according to international guidelines based on CRS-R evaluation as unresponsive wakefulness syndrome/vegetative state (UWS/VS) or minimally conscious state (MCS) either in the subacute or chronic stage Exclusion Criteria: * Age \< 18 years * History of epileptic seizures/status epilepticus * Scalp defects * pregnancy * Severe uncompensated heart failure (NYHA IV) * Atrioventricular block (AV block) second-degree and third-degree * Known bradycardia (below 55 beats/minute) * Known long QT interval (QTc according to Bazett \> 420 ms * History of serious ventricular arrhythmias * Hypokalemia or hypomagnesemia * Impaired renal function

What they're measuring

Coma Recovery Scale-Revised (CRS-R)

Timeframe: days 14 and 28

EEG band power alpha, beta, theta, delta

Timeframe: days 14 and 28

Trial details

NCT IDNCT06443827

SponsorAzienda Sanitaria dell'Alto Adige

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-10

View on ClinicalTrials.gov More Amantadine trials