Memantine for Neuroprotection and Cognitive Enhancement Following Traumatic Brain Injury

Indiana University

Status

Completed

Conditions

Traumatic Brain Injury

Treatments

Drug: Memantine

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02240589

A70-4-0791023

Details and patient eligibility

About

The purpose of this study is to determine if memantine can improve cognitive and neuropsychiatric outcomes after severe traumatic brain injury.

Full description

This is a pilot/feasibility study of memantine in severe traumatic brain injury (TBI) persons, employing a randomized, double-blind, placebo-controlled, design. Outcome evaluations will occur after 24 weeks of treatment (on medication) and 4 weeks after treatment discontinuation.

Enrollment

11 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18-65 years old of age at time of enrollment
Severe traumatic brain injury (TBI)
Feeding access (e.g., orogastric (OG), nasogastric (NG), or percutaneous endoscopic gastrostomy (PEG) tube) permitting delivery of memantine or placebo
Availability of legally-authorized representative (LAR) to provide consent and participate in some study activities (e.g., monitoring for side effects, providing information about the patient)

Exclusion criteria

Pre-existing history of serious neurological disorder
Pre-existing history of serious psychiatric disorder (e.g., schizophrenia)
Anticipated poor prognosis, based on the presence of bilaterally fixed and dilated pupils, severe hemodynamic instability, severe elevations in intracranial pressure refractory to interventions, or other factors leading to a determination of a probable non-survivable injury
Primarily penetrating mechanism of injury (e.g., gunshot wound to the head)
Isolated epidural hematoma with anticipated good prognosis
Low probability of participant being compliant or being able to finish study procedures (e.g., present for outcome rating) in the judgment of the investigator
Not English speaking (due to inability to complete outcome measure)
Medical contraindications to memantine: Severe hepatic impairment (defined as albumin > 15gm/dL, Alk Phos > 375 U/L, ALT > 150 U/L, AST > 120 U/L or bilirubin > 3mg/dL). Moderate-to-Severe renal impairment (defined as creatinine clearance < 60)
Pregnancy or breastfeeding