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Effect of Intravenous Amantadine Sulphate on Disorders of Consciousness

NCT06443827 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-06-14

No results posted yet for this study

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.

Conditions

  • Amantadine
  • Consciousness Disorders
  • Electroencephalography

Interventions

DRUG

Amantadine Sulfate

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

Sponsors & Collaborators

  • Azienda Sanitaria dell'Alto Adige

    lead OTHER

Principal Investigators

  • Viviana Versace, MD · hospital of Vipiteno

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-15
Primary Completion
2024-01-10
Completion
2024-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06443827 on ClinicalTrials.gov