• Augmentation of Cognitive Training in Children With TBI With D-Cyloserine

  NCT02312635

  Unknown statusInterventionalEarly Phase 1Updated Dec 9, 2014
• Effects of Weekly Dosing of D-cycloserine on Cognitive Function in Individuals With Schizophrenia

  NCT00455702

  CompletedInterventionalPhase 4Updated Aug 7, 2014
• D-cycloserine Augmentation of Cognitive Remediation in Schizophrenia

  NCT00963924

  CompletedInterventionalNot ApplicableUpdated Feb 6, 2018
• Effect of D-cycloserine on Treatment of Posttraumatic Stress Disorder (PTSD) in Youth

  NCT01157416

  CompletedInterventionalPhase 2Updated Apr 21, 2017
• The Cognitive Enhancing Effects of D-Cycloserine Among Non-Demented Elderly

  NCT01361633

  CompletedInterventionalPhase 2Updated Feb 18, 2021
• Traumatic Brain Injury and Effects of Acute Cyclosporine A

  NCT02496975

  WithdrawnInterventionalPhase 1Phase 2Updated Oct 26, 2017

ClinicalTrials.gov ID

NCT01343862

Lead Sponsor

Hadassah Medical OrganizationOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 2

Enrollment

100Estimated

Last Update Posted

Apr 28, 2011Estimated

Start Date

Aug 2011

Primary Completion Date

May 2014Estimated

Completion Date

May 2014Estimated

Official Title

The Effect of Single Dose D-Cycloserine on Cognitive Outcome in Moderate TBI Patients

Brief 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.

• Traumatic Brain Injury

• D-cycloserine
• placebo

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. TBI diagnosed by history and/or clinical examination with presenting GCS between 9 -13
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:

1. Penetrating brain injury
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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Hadassah Medical OrganizationOTHER

Knoller@sheba.health.gov.il