Traumatic Brain InjuryPhase 2NCT01673828
Allopregnanolone for the Treatment of Traumatic Brain Injury
A Phase 2 study testing Allopregnanolone injection in people with Traumatic Brain Injury and Posttraumatic Epilepsy, run by Michael A. Rogawski, MD, PhD at 1 site in United States.
Trial summary
This study will provide initial data on the safety and effectiveness of allopregnanolone in improving neurobehavioral outcome and reducing mortality in adults 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, Posttraumatic Epilepsy
- What is being tested?
- Allopregnanolone injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jul 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- English or Spanish speaking person
- Moderate to severe closed or blunt traumatic brain injury [post resuscitation Glasgow Coma Score (GCS) 3-12 with abnormal head CT scan if GCS is 9-12]
- Less than 8 hours from injury to study initiation
- Able to participate for the full term of the study
Who cannot join
- Subjects with life expectancy of less than 24 hours
- Isolated epidural hematoma
- Hypoxia (pulse oximetry saturation ≤90% for 15 or more minutes before enrollment)
- Hypotension (systolic blood pressure ≤90 mm Hg on 2 or more reliable measurements before enrollment)
- Cardiopulmonary arrest prior to randomization
- Spinal cord injury with motor deficits
Show all 16Show fewer
- Bilateral non-reactive pupils with Glasgow Coma Scale 3
- Body weight >120 kg
- Pregnancy
- Active breast or reproductive organ cancer
- Allergy to progesterone
- History of thromboembolic events
- Receipt of activated Factor VII before enrollment
- Any disease that is unstable or which could jeopardize the safety of the subject including severe renal impairment (creatinine clearance <50 ml/min)
- Prisoner/ward of the state
- Known treatment with another investigational drug therapy or procedure within 30 days of injury
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis Medical Center
Sacramento, California, 95817
About this study
Official title: A Double-blind, Placebo-controlled, Randomized Clinical Trial of Allopregnanolone for the Treatment of Traumatic Brain Injury
This study will provide initial data on the safety and effectiveness of allopregnanolone in improving neurobehavioral outcome and reducing mortality in adults with moderate and severe traumatic brain injury.
Read the detailed description
This is a double-blind, placebo-controlled, randomized, dose-finding, two-stage adaptive, clinical trial study comparing allopregnanolone to placebo when administered intravenously for 5 days beginning within 8 hours after injury. Test products to be administered are low and high dose allopregnanolone (Products L and H, respectively) and placebo (Product P) intravenous solutions. The products are administered during a 4-day treatment period followed by a 1-day dose de-escalation period. Stage 1 of the study will assess safety and confirm that dosing with Products L and H achieve the target steady-state plasma concentrations set for each of these products. Dosing will be adjusted in Stage 1, if necessary. Stage 2 will initially allocate subjects equally to Products L, H and P but will then use adaptive randomization to allocate subjects between Products L and H to optimized the probability of yielding a better 3-month Glasgow Outcome Score Extended (GOS-E) score.
- Conditions
- Traumatic Brain Injury, Posttraumatic Epilepsy
- Being tested
- Allopregnanolone injection, Placebo injection
- Keywords
- Brain Injuries, Pregnanolone, Epilepsy
- Medical subject headings
- Brain Injuries, Traumatic, Epilepsy, Post-Traumatic, Brain Injuries, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allopregnanolone injectionDrug
Also called 3α,5α-tetrahydroprogesterone, 3α-hydroxy-5α-pregnan-20-one, Product L (allopregnanolone intravenous solution, low dose), Product H (allopregnanolone intravenous solution, high dose)
Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium
Placebo injectionDrug
Also called Product P (placebo)
Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium
| Study group | Role | What they receive |
|---|---|---|
| Allopregnanolone | Experimental | Allopregnanolone injection (intravenous solution) continuous infusion for 5 days Receives: Drug: Allopregnanolone injection |
| Placebo | Placebo comparator | Placebo injection (intravenous solution) continuous infusion for 5 days Receives: Drug: Placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extended Glasgow Outcome Scale (GOS-E) Score
GOS-E is a global scale for functional outcome that rates patient status into one of 8 levels. The minimum score is 1 and the maximum score is 8. 1 = dead; 2 = vegetative state; 3 = low severe disability; 4 = upper severe disability; 5 = low moderate disability; 6 = upper moderate disability; 7 = low good recovery; 8 = upper good recovery. GOS-E was assessed by 19 question structured interview.
Measured: 6 months after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startApr 2013
- Primary completionMay 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael A. Rogawski, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, Michael A. Rogawski, MD, PhD, University of California, Davis
- Investigators
- Michael A Rogawski, MD, PhD, Principal investigator, University of California, DavisJoAnne E Natale, MD, PhD, Study director, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673828
- Sponsor's protocol ID
- 273147
- Other IDs
- DR081314
- Status last verified
- May 2017
- First submitted
- 20 Aug 2012
- Last updated
- 28 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized Clinical Trial of Allopregnanolone for the Treatment of Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01673828
- Acronym / sponsor ID
- 273147
- Conditions
- Traumatic Brain Injury, Posttraumatic Epilepsy
- Keywords
- Brain Injuries, Pregnanolone, Epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Michael A. Rogawski, MD, PhDUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Apr 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 28 Aug 2012 (estimated)
- Results
- Posted 28 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will provide initial data on the safety and effectiveness of allopregnanolone in improving neurobehavioral outcome and reducing mortality in adults with moderate and severe traumatic brain injury.
Detailed description
This is a double-blind, placebo-controlled, randomized, dose-finding, two-stage adaptive, clinical trial study comparing allopregnanolone to placebo when administered intravenously for 5 days beginning within 8 hours after injury. Test products to be administered are low and high dose allopregnanolone (Products L and H, respectively) and placebo (Product P) intravenous solutions. The products are administered during a 4-day treatment period followed by a 1-day dose de-escalation period. Stage 1 of the study will assess safety and confirm that dosing with Products L and H achieve the target steady-state plasma concentrations set for each of these products. Dosing will be adjusted in Stage 1, if necessary. Stage 2 will initially allocate subjects equally to Products L, H and P but will then use adaptive randomization to allocate subjects between Products L and H to optimized the probability of yielding a better 3-month Glasgow Outcome Score Extended (GOS-E) score.
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 |
|---|---|---|
| Allopregnanolone | Experimental | Drug: Allopregnanolone injectionAllopregnanolone injection (intravenous solution) continuous infusion for 5 days |
| Placebo | Placebo comparator | Drug: Placebo injectionPlacebo injection (intravenous solution) continuous infusion for 5 days |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- English or Spanish speaking person
- Moderate to severe closed or blunt traumatic brain injury [post resuscitation Glasgow Coma Score (GCS) 3-12 with abnormal head CT scan if GCS is 9-12]
- Less than 8 hours from injury to study initiation
- Able to participate for the full term of the study
Key exclusion criteria (16 listed)
- Subjects with life expectancy of less than 24 hours
- Isolated epidural hematoma
- Hypoxia (pulse oximetry saturation ≤90% for 15 or more minutes before enrollment)
- Hypotension (systolic blood pressure ≤90 mm Hg on 2 or more reliable measurements before enrollment)
- Cardiopulmonary arrest prior to randomization
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 |
|---|---|---|
| Allopregnanolone injectionAlso: 3α,5α-tetrahydroprogesterone, 3α-hydroxy-5α-pregnan-20-one, Product L (allopregnanolone intravenous solution, low dose), Product H (allopregnanolone intravenous solution, high dose)Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium | Drug | Allopregnanolone |
| Placebo injectionAlso: Product P (placebo)Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium | Drug | Placebo |
Primary outcome
Extended Glasgow Outcome Scale (GOS-E) Score
Time frame: 6 months after injury
GOS-E is a global scale for functional outcome that rates patient status into one of 8 levels. The minimum score is 1 and the maximum score is 8. 1 = dead; 2 = vegetative state; 3 = low severe disability; 4 = upper severe disability; 5 = low moderate disability; 6 = upper moderate disability; 7 = low good recovery; 8 = upper good recovery. GOS-E was assessed by 19 question structured interview.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Traumatic Brain Injury
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Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
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Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
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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.
Michael A Rogawski, MD, PhD principal investigator
University of California, Davis
JoAnne E Natale, MD, PhD study director
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allopregnanolone injection in people with Traumatic Brain Injury and Posttraumatic Epilepsy, run by Michael A. Rogawski, MD, PhD at 1 site in United States.
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 4 inclusion and 16 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: finished, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 28 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Extended Glasgow Outcome Scale (GOS-E) Score (time frame: 6 months after 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 Jun 2017.