Status:
COMPLETED
Memantine for Neuroprotection and Cognitive Enhancement Following Traumatic Brain Injury
Lead Sponsor:
Indiana University
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to determine if memantine can improve cognitive and neuropsychiatric outcomes after severe traumatic brain injury.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02240589
Start Date
December 1 2014
End Date
April 1 2016
Last Update
August 30 2017
Active Locations (1)
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1
Indiana University Health Facilities
Indianapolis, Indiana, United States, 46202