Traumatic Brain InjuryPhase 2DCSNCT01343862
The Effect of Single Dose D-Cycloserine on Cognitive Outcome in Moderate Traumatic Brain Injury (TBI) Patients
A Phase 2 study testing D-cycloserine in people with Traumatic Brain Injury, run by Hadassah Medical Organization at 3 sites in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- D-cycloserine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesIsrael
- Study dates
- Aug 2011to May 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Rambam Medical Center
Haifa
Leon Levi, MD, llevi@rambam.health.gov.il
Leon Levi, MD
Hadassah Medical Center
Jerusalem, 91120
Guy Rosenthal, MD
Sheba Medical Center
Ramat Gan
Nachshon Knoller, MD, Knoller@sheba.health.gov.il
Nachshon Knoller, MD
About this study
Official title: The Effect of Single Dose D-Cycloserine on Cognitive Outcome in Moderate TBI Patients
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
- Being tested
- D-cycloserine, placebo
- Keywords
- moderate traumatic brain injury, brain contusion
- Medical subject headings
- Brain Injuries, Traumatic, Brain Contusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-cycloserineDrug
Also called seromycin
single dose of D-cycloserine given 48-72 hours after moderate traumatic brain injury
placeboDrug
A sugar pill will be given to those patients randomized to the control group at 48-72 hours after moderate brain injury
| Study group | Role | What they receive |
|---|---|---|
| D- Cycloserine | Experimental | Not described Receives: Drug: D-cycloserine |
| sugar pill | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 and 6 months post-injury
Secondary outcomes (1)
Glasgow Outcome Score - Extended (GOS-E)
Measured: 3 and 6 months post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startAug 2011
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Guy Rosenthal, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343862
- Sponsor's protocol ID
- 0046-10-HMO
- Acronym
- DCS
- Status last verified
- Apr 2011
- First submitted
- 27 Apr 2011
- Last updated
- 28 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Single Dose D-Cycloserine on Cognitive Outcome in Moderate TBI Patients
- ClinicalTrials.gov ID
- NCT01343862
- Acronym / sponsor ID
- DCS / 0046-10-HMO
- Conditions
- Traumatic Brain Injury
- Keywords
- moderate traumatic brain injury, brain contusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 28 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D- Cycloserine | Experimental | Drug: D-cycloserine |
| sugar pill | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-cycloserineAlso: seromycinsingle dose of D-cycloserine given 48-72 hours after moderate traumatic brain injury | Drug | D- Cycloserine |
| placeboA sugar pill will be given to those patients randomized to the control group at 48-72 hours after moderate brain injury | Drug | sugar pill |
Primary outcome
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)
1 secondary outcome
Glasgow Outcome Score - Extended (GOS-E)
Time frame: 3 and 6 months post injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Rosenthal, MD principal investigator
Hadassah Medical Organization
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing D-cycloserine in people with Traumatic Brain Injury, run by Hadassah Medical Organization at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guy Rosenthal, MD (972-2-677-7092, rosenthalg@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A battery of neuropsychological tests at 3 and 6 months post-injury (time frame: 3 and 6 months post-injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2011.