Traumatic Brain InjuryPhase 2NCT00735085
A Phase 2a Dose Escalation Study With SLV334 in Patients With Traumatic Brain Injury.
A Phase 2 study testing SLV334 in people with Traumatic Brain Injury, run by Abbott Products at 14 sites in 4 countries.
Trial summary
A Randomized, Double Blind, Placebo Controlled, Phase 2 Dose Escalation Study to Investigate the Safety and Pharmacokinetics after Single and Multiple I.V. Doses of SLV334 in Sequential Cohorts of Patients with Moderate and Severe Traumatic Brain Injury. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- SLV334
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 14 sitesin 4 countries
- Study dates
- Apr 2009to Aug 2010
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female patients, age between 16 and 70 years, inclusive.
- Sustained a closed [non-penetrating] head trauma no more than 8 hours before initiation of drug treatment with study drug at the study hospital;
- TBI diagnosed by history, clinical examination with GCS of 12 or less.
- Evidence of TBI confirmed by abnormalities on CT scan
- Clinical indication to monitor ICP
- Informed consent is given.
Who cannot join
- Any spinal cord injury;
- Pregnant or lactating women;
- Patients with penetrating head injury;
- Bilaterally fixed dilated pupils at the time of randomization;
- Coma suspected to be primarily due to other causes than head injury such as drug or alcohol overdose;
- Severe multiple trauma or major organ failure (uncontrolled visceral bleeding, unstable cardio-respiratory or renal function);
- Known treatment with another investigational drug therapy within 30 days of injury.
- Life expectancy of less than 24 hours.
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
United States5 sites
Site Reference ID/Investigator# 45771
Baltimore, Maryland, 21201
Site Reference ID/Investigator# 45775
Dayton, Ohio, 45409
Site Reference ID/Investigator# 45785
Pittsburgh, Pennsylvania, 15212
Site Reference ID/Investigator# 45780
Pittsburgh, Pennsylvania, 15213
Site Reference ID/Investigator# 45770
Portland, Oregon, 97232
Israel4 sites
Site Reference ID/Investigator# 45727
Haifa, 31096
Site Reference ID/Investigator# 45726
Jerusalem, 91120
Site Reference ID/Investigator# 45723
Ramat Gan, 52621
Site Reference ID/Investigator# 45725
Tel Aviv, 64239
Spain3 sites
Site Reference ID/Investigator# 45765
Barcelona, 08035
Site Reference ID/Investigator# 45762
Madrid, 28041
Site Reference ID/Investigator# 45763
Palma de Mallorca, 07014
Italy2 sites
Site Reference ID/Investigator# 45735
Milan
Site Reference ID/Investigator# 45731
Monza, 20052
About this study
Official title: A Randomized, Double Blind, Placebo-Controlled Dose Escalation Study to Investigate the Safety and Pharmacokinetics After Single and Multiple Doses of SLV334 in Sequential Cohorts of Patients With Moderate and Severe Traumatic Brain Injury
A Randomized, Double Blind, Placebo Controlled, Phase 2 Dose Escalation Study to Investigate the Safety and Pharmacokinetics after Single and Multiple I.V. Doses of SLV334 in Sequential Cohorts of Patients with Moderate and Severe Traumatic Brain Injury.
- Conditions
- Traumatic Brain Injury
- Being tested
- SLV334, Placebo
- Keywords
- Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLV334Drug
1000mg SLV334 as a single dose
SLV334Drug
1000mg SLV334 b.i.d. for one day
SLV334Drug
2000mg SLV334 b.i.d. for one day
SLV334Drug
2000mg SLV334 b.i.d. for three days
PlaceboDrug
SLV334 Placebo arm
| Study group | Role | What they receive |
|---|---|---|
| SLV334 | Experimental | Not described Receives: Drug: SLV334 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of SLV334 including mortality, adverse events (AE), serious adverse events (SAE), vitals signs, laboratory variables and ECG
Measured: 2 weeks
Secondary outcomes (1)
PK parameters of SLV334
Measured: up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startApr 2009
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: This study was stopped 20 May 2010 due to strategic considerations
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.
- 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Juliana Bronzowa, MD, Study director, Abbott Products
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735085
- Sponsor's protocol ID
- S334.2.002
- Other IDs
- 2008-001409-40, 2008
- Status last verified
- Sep 2011
- First submitted
- 30 Nov 2007
- Last updated
- 21 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-Controlled Dose Escalation Study to Investigate the Safety and Pharmacokinetics After Single and Multiple Doses of SLV334 in Sequential Cohorts of Patients With Moderate and Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00735085
- Acronym / sponsor ID
- S334.2.002
- Conditions
- Traumatic Brain Injury
- Keywords
- Brain Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was stopped 20 May 2010 due to strategic considerations
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Abbott ProductsIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Apr 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 14 Aug 2008 (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.
A Randomized, Double Blind, Placebo Controlled, Phase 2 Dose Escalation Study to Investigate the Safety and Pharmacokinetics after Single and Multiple I.V. Doses of SLV334 in Sequential Cohorts of Patients with Moderate and Severe Traumatic 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 |
|---|---|---|
| SLV334 | Experimental | Drug: SLV334 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients, age between 16 and 70 years, inclusive.
- Sustained a closed [non-penetrating] head trauma no more than 8 hours before initiation of drug treatment with study drug at the study hospital;
- TBI diagnosed by history, clinical examination with GCS of 12 or less.
- Evidence of TBI confirmed by abnormalities on CT scan
- Clinical indication to monitor ICP
Key exclusion criteria (8 listed)
- Any spinal cord injury;
- Pregnant or lactating women;
- Patients with penetrating head injury;
- Bilaterally fixed dilated pupils at the time of randomization;
- Coma suspected to be primarily due to other causes than head injury such as drug or alcohol overdose;
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 |
|---|---|---|
| SLV3341000mg SLV334 as a single dose | Drug | SLV334 |
| SLV3341000mg SLV334 b.i.d. for one day | Drug | SLV334 |
| SLV3342000mg SLV334 b.i.d. for one day | Drug | SLV334 |
| SLV3342000mg SLV334 b.i.d. for three days | Drug | SLV334 |
| PlaceboSLV334 Placebo arm | Drug | Placebo |
Primary outcome
Safety of SLV334 including mortality, adverse events (AE), serious adverse events (SAE), vitals signs, laboratory variables and ECG
Time frame: 2 weeks
1 secondary outcome
PK parameters of SLV334
Time frame: up to 4 days
Results and safety
The study was stopped early (reason given: This study was stopped 20 May 2010 due to strategic considerations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 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.
Juliana Bronzowa, MD study director
Abbott Products
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SLV334 in people with Traumatic Brain Injury, run by Abbott Products at 14 sites in 4 countries.
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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 21 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Israel, Spain, Italy. 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?
The study was stopped early (reason given: This study was stopped 20 May 2010 due to strategic considerations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of SLV334 including mortality, adverse events (AE), serious adverse events (SAE), vitals signs, laboratory variables and ECG (time frame: 2 weeks). 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 21 Sep 2011; AzTrials last refreshed its copy on 31 Oct 2026.