Clinical trial NCT02240589: Memantine for Neuroprotection and Cognitive Enhancement Following Traumatic Brain Injury
Official title: Memantine for Neuroprotection and Cognitive Enhancement Following Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
Memantine
Memory
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2014-09-15
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 weeks of treatment (on medication) and 4 weeks after treatment discontinuation.

Eligibility criteria: 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

Primary outcomes:
measure: California Verbal Learning Test - Second Edition (CVLT-II) - Long Delay Free Recall
timeFrame: Week 24
Secondary outcomes:
measure: CVLT-II Trials 1-5 Free Recall Total
timeFrame: Week 24
measure: Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed Recall
timeFrame: Week 24
measure: BVMT-R Learning
timeFrame: Week 24
measure: Trail Making Part B
timeFrame: Week 24
measure: Stroop Interference
timeFrame: Week 24
measure: Behavior Rating Inventory of Executive Function (BRIEF) Inhibit
timeFrame: Week 24
measure: Traumatic Brain Injury Quality of Life Anger (TBI QOL Anger)
timeFrame: Week 24
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health Facilities
state: Indiana
Study officials:
affiliation: Indiana University
name: Flora Hammond, MD
role: PRINCIPAL_INVESTIGATOR
References: