Memantine for Neuroprotection and Cognitive Enhancement Following Traumatic Brain Injury
Information source: Indiana University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Traumatic Brain Injury
Intervention: Memantine (Drug); Placebo (Drug)
Phase: N/A
Status: Enrolling by invitation
Sponsored by: Indiana University Official(s) and/or principal investigator(s): Flora Hammond, MD, Principal Investigator, Affiliation: Indiana University
Summary
The purpose of this study is to determine if memantine can improve cognitive and
neuropsychiatric outcomes after severe traumatic brain injury.
Clinical Details
Official title: Memantine for Neuroprotection and Cognitive Enhancement Following Traumatic Brain Injury
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: California Verbal Learning Test - Second Edition (CVLT-II) - free delayed recall
Secondary outcome: CVLT-II Trials 1-5 TotalCVLT-II % retention Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed Recall BVMT-R Trials 1-3 Trail Making Part B Stroop interference Behavior Rating Inventory of Executive Function (BRIEF) Inhibit Traumatic Brain Injury Quality of Life Anger (TBI QOL Anger)
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Indiana University Health Facilities, Indianapolis, Indiana 46202, United States
Additional Information
Starting date: December 2014
Last updated: May 29, 2015
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