The Effect of Single Dose D-Cycloserine on Cognitive Outcome in Moderate Traumatic Brain Injury (TBI) Patients
NCT01343862 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2011-04-28
Summary
In this study of patients with moderate traumatic brain injury with frontal brain contusions patients will be randomized to treatment with a single dose of either D-cycloserine or placebo given 48-72 hours after injury.
Patients will undergo intensive neurocognitive testing at 3 and 6 months after injury to assess whether treatment with a single dose of D-cycloserine improves cognitive outcome after moderate brain injury.
Conditions
Interventions
- DRUG
-
single dose of D-cycloserine given 48-72 hours after moderate traumatic brain injury
- DRUG
-
A sugar pill will be given to those patients randomized to the control group at 48-72 hours after moderate brain injury
Sponsors & Collaborators
-
Hadassah Medical Organization
lead OTHER
Principal Investigators
-
Guy Rosenthal, MD · Hadassah Medical Organization
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-08-31
- Primary Completion
- 2014-05-31
- Completion
- 2014-05-31
Countries
- Israel
Study Locations
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