Memantine for Neuroprotection and Cognitive Enhancement Following Traumatic Brain Injury

NCT02240589 | Completed Results

• 1 other identifier: A70-4-0791023
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury; Memantine; Memory

Outcome Measures

Primary Outcomes (1)

• California Verbal Learning Test - Second Edition (CVLT-II) - Long Delay Free Recall

  Neuropsychological test used to assess an individual's verbal memory abilities. The California Verbal Learning Test-Second Edition (CVLT-II) Long Delay Free Recall measures total word list items recalled after a 20-minute delay. The raw score is converted to a Z-score (Mean=0; SD=1) which was used for statistical analysis. Higher scores reflect worse performance (i.e., more recall errors) on this variable.

  Week 24

Secondary Outcomes (7)

• CVLT-II Trials 1-5 Free Recall Total

  Week 24

• Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed Recall

  Week 24

• BVMT-R Learning

  Week 24

• Trail Making Part B

  Week 24

• Stroop Interference

  Week 24

Study Arms (2)

Memantine

EXPERIMENTAL

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

Drug: Memantine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Memantine 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.

Also known as: Namenda

Memantine

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Health Facilities

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Memantine

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Small sample size.

Results Point of Contact

• Title: Flora Hammond, MD
• Organization: Indiana University School of Medicine

flora.hammond@rhin.com

317-329-2106

Study Officials

• Flora Hammond, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Covalt Professor & Chair

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 15, 2014
• Study Start: December 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 30, 2017
• Results First Posted: August 30, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)