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Brazilian trial of Amantadine for disorders of consciousness after intracranial bleeding due to aneurysm rupture

Amantadine for disorders of consciousness after Aneurysmal Subarachnoid Hemorrhage

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-6789t4v
Enrollment
Unknown
Registered
2023-01-19
Start date
2020-01-20
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subarachnoid hemorrhage

Interventions

This is a double-blinded, randomized controlled trial with two groups. Intervention group: 30 individuals with aneurysmal subarachnoid hemorrhage will receive amantadine, oral pills, administered for
100mg 12/12h week 2
150mg 12/12h week 3
200mg 12/12h following weeks. Control group: 30 individuals will receive placebo, oral pill, administered for 6 weeks: 1 pill in the morning in week 1
1 pill 12/12h for the following weeks.
D02.455.426.100.050.035

Sponsors

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Lead Sponsor
Hospital Universitário Cajuru da Pontifícia Universidade Católica do Paraná
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients with spontaneous subarachnoid hemorrhage due to cerebral aneurysm rupture; adults; both genders

Exclusion criteria

Exclusion criteria: Unfavorable previous baseline neurological status, defined as modified Rankin Scale (mRS) greater than 2; pediatric patients

Design outcomes

Secondary

MeasureTime frame
We are expecting a reduction in disability progression, determined through the Glasgow Outcome Scale 3 and 6 months after discharge, verified through a statistically significant difference between groups.;We are expecting a reduction in mortality, verified through a statistically significant difference between groups.

Primary

MeasureTime frame
We are expecting a reduction in disability progression, determined through the Modified Rankin Scale 3 and 6 months after discharge, verified through a statistically significant difference between groups.

Countries

Brazil

Contacts

Public ContactLuana Gatto

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

cappesq.adm@hc.fm.usp.br+551126617585

Outcome results

None listed

Source: REBEC (via WHO ICTRP)