Memantine for Neuroprotection and Cognitive Enhancement Following Traumatic Brain Injury

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-04-30

Brief Summary

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The purpose of this study is to determine if memantine can improve cognitive and neuropsychiatric outcomes after severe traumatic brain injury.

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Detailed Description

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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.

Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Memantine

24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.

Group Type EXPERIMENTAL

Memantine

Intervention Type DRUG

Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine.

Placebo

24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo.

Interventions

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Memantine

Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine.

Intervention Type DRUG

Placebo

Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo.

Intervention Type DRUG

Other Intervention Names

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Namenda

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No