Effect of Intravenous Amantadine Sulphate on Disorders of Consciousness (DOC-AMSUL)

Azienda Sanitaria dell'Alto Adige

Status and phase: Active, not recruiting; Phase 2

Conditions: Electroencephalography; Consciousness Disorders; Amantadine

Treatments: Drug: Amantadine Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT06443827

39049

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

amantadine sulphate and placebo with schema A-B-A-B

Experimental group

Description:

To obtain solid evidence of amantadine sulphate effects and their temporal dynamics, we conducted a double-blind, placebo-controlled, crossover ("within subjects") study with an A-B-A-B treatment scheme, in which "placebo" (A) and "amantadine sulphate" (B) intervention sessions alternated weekly in the same patient for a total of four weeks (A1-B1-A2-B2).

Treatment:

Drug: Amantadine Sulfate