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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01343862
Other study ID # 0046-10-HMO
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received April 27, 2011
Last updated April 27, 2011
Start date August 2011
Est. completion date May 2014

Study information

Verified date April 2011
Source Hadassah Medical Organization
Contact Guy Rosenthal, MD
Phone 972-2-677-7092
Email rosenthalg@hadassah.org.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
Israel Rambam Medical Center Haifa
Israel Hadassah Medical Center Jerusalem
Israel Sheba Medical Center Ramat Gan

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary A battery of neuropsychological tests at 3 and 6 months post-injury Symbol Digit Modalities Test (Smith 1973)
Trail Making Test (TMT) (Reitan, Hom et al. 1988)
Digit Span (DS) from the WAIS-III
Rey Auditory Verbal Learning Test (RAVLT) (Rey 1955; Lezak 2004)
Wisconsin Card Sorting Test (WCST) (Psychological Assessment Resources. Computerised Wisconsin Card Sort Task Version 4 (WCST). Psychological Assessment Resources; 2003).
Test of Variables of Attention (TOVA) (Test of Variables of Attention: Clinical Manual. Los Alamitos: The TOVA Company).
Behavioral Assessment of the Dysexecutive Syndrome (BADS) (Erez, Rothschild et al. 2009)
3 and 6 months post-injury No
Secondary Glasgow Outcome Score - Extended (GOS-E) 3 and 6 months post injury No
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