The Effect of Single Dose D-Cycloserine on Cognitive Outcome in Moderate Traumatic Brain Injury (TBI) Patients

NCT01343862 | Unknown Phase 2 DMC

• 1 other identifier: 0046-10-HMO
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Traumatic Brain Injury

Keywords

moderate traumatic brain injury; brain contusion

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Glasgow Outcome Score - Extended (GOS-E)

  3 and 6 months post injury

Study Arms (2)

D- Cycloserine

EXPERIMENTAL

Drug: D-cycloserine

sugar pill

PLACEBO COMPARATOR

Drug: placebo

Interventions

D-cycloserine DRUG

single dose of D-cycloserine given 48-72 hours after moderate traumatic brain injury

Also known as: seromycin

D- Cycloserine

placebo DRUG

A sugar pill will be given to those patients randomized to the control group at 48-72 hours after moderate brain injury

sugar pill

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• TBI diagnosed by history and/or clinical examination with presenting GCS between 9 -13
• Age between 18 and 55 years
• Frontal cerebral contusion(s) located in the frontal cortex and/or traumatic subarachnoid hemorrhage on initial CT scan
• Prior to randomization, patient is able to swallow an orally administered tablet or has a nasogastric tube in place per medical indication
• 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.

You may not qualify if:

• Penetrating brain injury
• Any traumatic intracranial lesion requiring neurosurgical intervention prior to time of randomization
• Other severe systemic injuries leading to severe hypotension, hemodynamic instability following initial resuscitation (SBP \< 90 mmHg), severe hypoxia.
• Intubation lasting \> 12 hours prior to randomization
• Suspected or confirmed pregnancy or lactating women
• Any spinal cord injury
• Known or CT scan evidence of previous major cerebral damage
• Any severe concomitant condition (malignancy, renal, hepatic, or major psychiatric disorder)
• Known treatment with another investigational drug within 30 days of injury
• Known contraindication to enteral administration of drug prior to randomization (GI bleed, ileus, severe abdominal injury, etc.)
• Known contraindication to placement of a nasogastric tube in patients unable to swallow an orally administered tablet

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (3)

Rambam Medical Center

Haifa, Israel

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Contusion

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Contusions; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Guy Rosenthal, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guy Rosenthal, MD

CONTACT

972-2-677-7092; rosenthalg@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: April 28, 2011
• Study Start: August 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: April 28, 2011

Record last verified: 2011-04

Locations

IL (3)