The Effect of Single Dose D-Cycloserine on Cognitive Outcome in Moderate Traumatic Brain Injury (TBI) Patients
NCT ID: NCT01343862
Last Updated: 2011-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2011-08-31
2014-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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D- Cycloserine
D-cycloserine
single dose of D-cycloserine given 48-72 hours after moderate traumatic brain injury
sugar pill
placebo
A sugar pill will be given to those patients randomized to the control group at 48-72 hours after moderate brain injury
Interventions
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D-cycloserine
single dose of D-cycloserine given 48-72 hours after moderate traumatic brain injury
placebo
A sugar pill will be given to those patients randomized to the control group at 48-72 hours after moderate brain injury
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age between 18 and 55 years
3. Frontal cerebral contusion(s) located in the frontal cortex and/or traumatic subarachnoid hemorrhage on initial CT scan
4. Prior to randomization, patient is able to swallow an orally administered tablet or has a nasogastric tube in place per medical indication
5. Informed consent will be obtained in those patients who have regained full cognition and judgment following their injury and are fully capable of understanding the study protocol, its risks and potential benefits, and of giving informed consent for participation in the study. In any patient that has not regained full cognition and judgment, only a temporary legal guardian (apotropos) appointed by an authorized judge that has been given a full explanation of the study protocol, its risks and potential benefits will be authorized to give informed consent for participation in the study.
Exclusion Criteria
2. Any traumatic intracranial lesion requiring neurosurgical intervention prior to time of randomization
3. Other severe systemic injuries leading to severe hypotension, hemodynamic instability following initial resuscitation (SBP \< 90 mmHg), severe hypoxia.
4. Intubation lasting \> 12 hours prior to randomization
5. Suspected or confirmed pregnancy or lactating women
6. Any spinal cord injury
7. Known or CT scan evidence of previous major cerebral damage
8. Any severe concomitant condition (malignancy, renal, hepatic, or major psychiatric disorder)
9. Known treatment with another investigational drug within 30 days of injury
10. Known contraindication to enteral administration of drug prior to randomization (GI bleed, ileus, severe abdominal injury, etc.)
11. Known contraindication to placement of a nasogastric tube in patients unable to swallow an orally administered tablet
18 Years
55 Years
ALL
No
Sponsors
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Hadassah Medical Organization
OTHER
Responsible Party
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Department of Neurosurgery, Hadassah-Hebrew University Medical Center
Principal Investigators
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Guy Rosenthal, MD
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Locations
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Rambam Medical Center
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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Leon Levi, MD
Role: primary
Nachshon Knoller, MD
Role: primary
Other Identifiers
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0046-10-HMO
Identifier Type: -
Identifier Source: org_study_id