N/A
N=11
Memantine for Neuroprotection and Cognitive Enhancement Following Traumatic Brain Injury
Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT02240589 ↗Enrolled (actual)
11
Serious AEs
9.1%
Results posted
Aug 2017
Primary outcome: Primary: California Verbal Learning Test - Second Edition (CVLT-II) - Long Delay Free Recall — -2.000; -1.375 z-score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Memantine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY California Verbal Learning Test - Second Edition (CVLT-II) - Long Delay Free Recall |
-2.000; -1.375 | — |
| SECONDARY CVLT-II Trials 1-5 Free Recall Total |
31.000; 37.250 | — |
| SECONDARY Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed Recall |
47.00; 45.50 | — |
| SECONDARY BVMT-R Learning |
60.00; 46.50 | — |
| SECONDARY Trail Making Part B |
11.67; 13.25 | — |
| SECONDARY Stroop Interference |
51.67; 52.25 | — |
| SECONDARY Behavior Rating Inventory of Executive Function (BRIEF) Inhibit |
46.00; 61.00 | — |
| SECONDARY Traumatic Brain Injury Quality of Life Anger (TBI QOL Anger) |
49.725; 45.375 | — |
Summary
The purpose of this study is to determine if memantine can improve cognitive and neuropsychiatric outcomes after severe traumatic brain injury.
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
Data sourced from ClinicalTrials.gov (NCT02240589). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.