Memantine for Neuroprotection and Cognitive Enhancement Following Traumatic Brain Injury
Completed · Not applicable · Has a placebo group
Conditions studied: Traumatic Brain Injury
In brief
The purpose of this study is to determine if memantine can improve cognitive and neuropsychiatric outcomes after severe traumatic brain injury.
Key facts
- Study ID
- NCT02240589
- Run by
- Indiana University
- People needed
- 11
- Starts
- 2014-12-01
- Expected to finish
- 2016-04-01
- Last updated by the study team
- 2017-08-30
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
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
Where it is running
- Indiana University Health Facilities — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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