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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 Total

CVLT-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

Page last updated: August 23, 2015

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