TBIPhase 2NCT02990091
Derivatives of Omega-3 HUFA as Biomarkers of Traumatic Brain Injury
A Phase 2 study testing Omega 3 fatty acid and Safflower seed oil in people with TBI, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is a Phase 2 clinical trial designed to obtain data on relationships between potentially therapeutic doses of n-3 HUFA (highly unsaturated fatty acids) and their bioactive molecular derivatives, synaptamide, 17-hydroxy-DHA, and D-series resolvins, on clinical outcomes after TBI. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- TBI
- What is being tested?
- Omega 3 fatty acid and Safflower seed oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Dec 2023
- 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
- Age 18-55
- Documented/ verified TBI
- Ability to swallow study agent within 48h of injury
- If a sexually active female who is able to get pregnant, must be already taking birth control (prescription contraception)
- Visual acuity/ hearing adequate for testing
- Fluency in English or Spanish
Show all 9Show fewer
- Ability to provide informed consent for themselves
- Co-enrolled in PARC-TBI protocol (IRB protocol #825783) or TRACK-TBI (IRB protocol #825503)
- GCS 13-15
Who cannot join
- Unstable respiratory or hemodynamic status
- Evidence of penetrating brain injury
- Requirement for craniotomy or craniectomy
- Evidence of serious infectious complications
- Acute ischemic heart disease or abnormal heart rhythm
- History of abnormality in liver function
Show all 18Show fewer
- History or evidence of active malignancy
- History of diabetes
- History of pre-existing neurologic disorder, such as dementia, uncontrolled epilepsy, multiple sclerosis, strokes, brain tumors, prior severe TBI, or other disorder that confounds interpretation neuropsychological results
- History of pre-existing disabling Axis I psychiatric disorder, such as major depression, schizophrenia, bipolar disorder or dementia
- Allergy to omega-3 fatty acid ethyl esters or any ingredient of the study agent.
- Known allergy to Safflower seed oil or ragweed plants
- Consumption of fish or seafood 3 or more times per week on average or regular administration of omega-3 supplements (e.g., cod liver oil, borage oil, fish oil or evening primrose oil) defined as an average of 250 mg/day of n-3 HUFAs, over the previous 3 months.
- Pregnancy or breast-feeding
- Prisoners or patients in custody
- Allergy, hypersensitivity, or intolerance to fish oils or omega-3 fats which are found in fish.
- Use of anticoagulant medications or aspirin more than once per week within the last three months
- Enrollment in any concurrent research protocols that would interfere with participant safety or research data integrity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Traumatic Brain Injury Recovery With n-3 Highly Unsaturated Fatty Acids (HUFAs): A Biomarker-driven Approach
This is a Phase 2 clinical trial designed to obtain data on relationships between potentially therapeutic doses of n-3 HUFA (highly unsaturated fatty acids) and their bioactive molecular derivatives, synaptamide, 17-hydroxy-DHA, and D-series resolvins, on clinical outcomes after TBI.
- Conditions
- TBI
- Being tested
- Omega 3 fatty acid, Safflower seed oil
- Keywords
- TBI, DHA, omega-3 highly unsaturated fatty acids, synaptamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3 fatty acidDrug
Also called LOVAZA
LOVAZA is an FDA approved drug that is lawfully marketed in the United States by GlaxoSmithKline. There is no intent to use the results of this study to support a change in the labeling or the advertising of the drug. The highest dose administered for the study is the recommended prescribed dose of LOVAZA, therefore not creating greater risk. The patient population and route of administration will not significantly increase the risk associated with the use of the product. We will be using this drug under an IND exemption.
Safflower seed oilDietary supplement
Safflower seed oil is a commonly used dietary supplement. It has been chosen to be used as a comparative to the LOVAZA because of its non-omega-3 fats. There will be no increased risk due to dosage, route of administration, or patient population.
| Study group | Role | What they receive |
|---|---|---|
| 1,000mg/day n-3 HUFA | Experimental | Subjects will take one capsule daily starting at study enrollment (within 24 hours of injury) for 14 consecutive days. Receives: Drug: Omega 3 fatty acid |
| 4,000 mg/day n-3 HUFA | Experimental | Subjects will take 2 capsules twice daily starting at enrollment (within 24 hours of injury) for 14 consecutive days. Receives: Drug: Omega 3 fatty acid |
| 1 capsule safflower seed oil | Placebo comparator | Subjects will take 1 capsule daily starting at enrollment (within 24 hours of injury) for 14 consecutive days. Receives: Dietary Supplement: Safflower seed oil |
| 4 capsules safflower seed oil | Placebo comparator | Subjects will take 2 capsules twice daily starting at enrollment (within 24 hours of injury) for 14 consecutive days. Receives: Dietary Supplement: Safflower seed oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship of varying doses of n-3 HUFAs on blood levels of the following bioactive metabolites
Bioactive metabolites being looked at are: synaptamide (n-docosahexaenoylethanolamine), 17-hydroxy-DHA, and D-series resolvins and determine relationship of n-3 HUFAs on blood levels of indicators of neuroinflammatory damage including Brain Derived Neurotrophic Factor (BDNF) in humans over 14 days after TBI.
Measured: 14 days consecutively
Secondary outcomes (2)
Relationship of n-3 HUFA blood levels and clinical outcomes measured by the Glasgow Outcome Scale-Extended (GOSE)
Clinical outcomes will include functional outcomes and will be assessed by using the TBI Common Data Elements Outcome battery. The analysis will focus on the Glasgow Outcome Scale-Extended (GOS-E) an ordinal scale based on a structured questionnaire which is universally used in TBI clinical studies.
Measured: 14 days consecutively
Evalute potential adverse events
Evaluate potential adverse side effects including gastrointestinal tolerance and adverse neurological outcomes.
Measured: 14 days consecutively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Unable to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBIStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Ramon Diaz-Arrastia, University of Pennsylvania
- Investigators
- Ramon Diaz-Arrastia, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990091
- Sponsor's protocol ID
- 826109
- Status last verified
- Oct 2022
- First submitted
- 5 Dec 2016
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traumatic Brain Injury Recovery With n-3 Highly Unsaturated Fatty Acids (HUFAs): A Biomarker-driven Approach
- ClinicalTrials.gov ID
- NCT02990091
- Acronym / sponsor ID
- 826109
- Conditions
- TBI
- Keywords
- TBI, DHA, omega-3 highly unsaturated fatty acids, synaptamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jan 2017
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 12 Dec 2016 (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.
This is a Phase 2 clinical trial designed to obtain data on relationships between potentially therapeutic doses of n-3 HUFA (highly unsaturated fatty acids) and their bioactive molecular derivatives, synaptamide, 17-hydroxy-DHA, and D-series resolvins, on clinical outcomes after TBI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1,000mg/day n-3 HUFA | Experimental | Drug: Omega 3 fatty acidSubjects will take one capsule daily starting at study enrollment (within 24 hours of injury) for 14 consecutive days. |
| 4,000 mg/day n-3 HUFA | Experimental | Drug: Omega 3 fatty acidSubjects will take 2 capsules twice daily starting at enrollment (within 24 hours of injury) for 14 consecutive days. |
| 1 capsule safflower seed oil | Placebo comparator | Dietary Supplement: Safflower seed oilSubjects will take 1 capsule daily starting at enrollment (within 24 hours of injury) for 14 consecutive days. |
| 4 capsules safflower seed oil | Placebo comparator | Dietary Supplement: Safflower seed oilSubjects will take 2 capsules twice daily starting at enrollment (within 24 hours of injury) for 14 consecutive days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 18-55
- Documented/ verified TBI
- Ability to swallow study agent within 48h of injury
- If a sexually active female who is able to get pregnant, must be already taking birth control (prescription contraception)
- Visual acuity/ hearing adequate for testing
Key exclusion criteria (18 listed)
- Unstable respiratory or hemodynamic status
- Evidence of penetrating brain injury
- Requirement for craniotomy or craniectomy
- Evidence of serious infectious complications
- Acute ischemic heart disease or abnormal heart rhythm
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 |
|---|---|---|
| Omega 3 fatty acidAlso: LOVAZALOVAZA is an FDA approved drug that is lawfully marketed in the United States by GlaxoSmithKline. There is no intent to use the results of this study to support a change in the labeling or the advertising of the drug. The highest dose administered for the study is the recommended prescribed dose of LOVAZA, therefore not creating greater risk. The patient population and route of administration will not significantly increase the risk associated with the use of the product. We will be using this drug under an IND exemption. | Drug | 1,000mg/day n-3 HUFA, 4,000 mg/day n-3 HUFA |
| Safflower seed oilSafflower seed oil is a commonly used dietary supplement. It has been chosen to be used as a comparative to the LOVAZA because of its non-omega-3 fats. There will be no increased risk due to dosage, route of administration, or patient population. | Dietary supplement | 1 capsule safflower seed oil, 4 capsules safflower seed oil |
Primary outcome
Relationship of varying doses of n-3 HUFAs on blood levels of the following bioactive metabolites
Time frame: 14 days consecutively
Bioactive metabolites being looked at are: synaptamide (n-docosahexaenoylethanolamine), 17-hydroxy-DHA, and D-series resolvins and determine relationship of n-3 HUFAs on blood levels of indicators of neuroinflammatory damage including Brain Derived Neurotrophic Factor (BDNF) in humans over 14 days after TBI.
2 secondary outcomes
Relationship of n-3 HUFA blood levels and clinical outcomes measured by the Glasgow Outcome Scale-Extended (GOSE)
Time frame: 14 days consecutively
Evalute potential adverse events
Time frame: 14 days consecutively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for TBI
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 2
Thiotepa + TBI + Fludarabine + Etoposide for Allo-HSCT in Patients With R/R or High-risk Acute Leukemia
Acute Leukemia, High Risk, Acute Leukemia Refractory
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
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.
Ramon Diaz-Arrastia, MD, PhD principal investigator
University of Pennsylvania
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 Omega 3 fatty acid and Safflower seed oil in people with TBI, run by University of Pennsylvania 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 9 inclusion and 18 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: withdrawn, as of the sponsor's last update on 13 Oct 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Relationship of varying doses of n-3 HUFAs on blood levels of the following bioactive metabolites (time frame: 14 days consecutively). 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 13 Oct 2022.