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Trial record 30 of 121 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

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

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ClinicalTrials.gov Identifier: NCT01343862
Recruitment Status : Unknown
Verified April 2011 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : April 28, 2011
Last Update Posted : April 28, 2011
Sponsor:
Information provided by:
Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE April 27, 2011
First Posted Date  ICMJE April 28, 2011
Last Update Posted Date April 28, 2011
Study Start Date  ICMJE August 2011
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2011)
A battery of neuropsychological tests at 3 and 6 months post-injury [ Time Frame: 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2011)
Glasgow Outcome Score - Extended (GOS-E) [ Time Frame: 3 and 6 months post injury ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Single Dose D-Cycloserine on Cognitive Outcome in Moderate Traumatic Brain Injury (TBI) Patients
Official Title  ICMJE 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Traumatic Brain Injury
Intervention  ICMJE
  • Drug: D-cycloserine
    single dose of D-cycloserine given 48-72 hours after moderate traumatic brain injury
    Other Name: seromycin
  • Drug: placebo
    A sugar pill will be given to those patients randomized to the control group at 48-72 hours after moderate brain injury
Study Arms  ICMJE
  • Experimental: D- Cycloserine
    Intervention: Drug: D-cycloserine
  • Placebo Comparator: sugar pill
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 27, 2011)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2014
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01343862
Other Study ID Numbers  ICMJE 0046-10-HMO
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guy Rosenthal, MD, Hadassah-Hebrew University Medical Center, Department of Neurosurgery, Hadassah-Hebrew University Medical Center
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guy Rosenthal, MD Hadassah Medical Center
PRS Account Hadassah Medical Organization
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP