Effect of Intravenous Amantadine Sulphate on Disorders of Consciousness

NCT ID: NCT06443827

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-15
• Study Completion Date: 2024-09-30

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.

Conditions

Amantadine; Consciousness Disorders; Electroencephalography

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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).

Group Type: EXPERIMENTAL

Amantadine Sulfate

Intervention Type: DRUG

intravenous amantadine sulphate at a single daily dose of 200 mg or physiological saline (0.9% NaCl solution)

Interventions

Amantadine Sulfate

intravenous amantadine sulphate at a single daily dose of 200 mg or physiological saline (0.9% NaCl solution)

Intervention Type: DRUG

Other Intervention Names

physiological saline (0.9% NaCl solution)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Azienda Sanitaria dell'Alto Adige

OTHER

Sponsor Role: lead

Responsible Party

Viviana Versace

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Viviana Versace, MD

Role: PRINCIPAL_INVESTIGATOR

hospital of Vipiteno

Locations

Hospital of Vipiteno

Sterzing, Bolzano, Italy

Countries

Italy

Other Identifiers

39049

Identifier Type: -

Identifier Source: org_study_id