OPTIMA-TBI Pilot Study

NCT03345550 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: HUM00129045
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-blind, randomized controlled trial comparing the effect of omega-3 fatty acid versus placebo on blood biomarkers of brain injury, inflammation and neurogenesis.

Conditions

Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (3)

• Biomarker Endpoints (NFL)

  Neuronal injury measured by Neurofilament Light Chain (NFL). Samples will be analyzed using a digital immunoassay based on a single molecule counting technology.

  Baseline,3 months

• Biomarker Endpoint (Inflammation)

  We will measure serum levels of high sensitivity C-Reactive Protein (CRP)

  3 months

• Biomarker Endpoint (Neurogenesis)

  Serum levels of brain derived neurotrophic factor (BDNF)

  3 months

Secondary Outcomes (3)

• Delayed Functional Recovery

  3 months

• Gastrointestinal Distress

  3 months

• Clinically Significant Bleeding

  3 months

Other Outcomes (2)

• Cognitive Impairment

  3 months

• Moderate/Severe Post-Concussive Symptoms

  3 months

Study Arms (2)

Omega-3 Polyunsaturated Fatty Acid Treatment Arm

EXPERIMENTAL

Participants randomized to this study arm will receive 6g DHA+EPA for one month followed by 1.2 g DHA+EPA for two months. Capsules contain fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules.

Drug: Omega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA & 100 mg EPA)) or placebo capsules.

Placebo Arm

PLACEBO COMPARATOR

Participants randomized to this study arm will receive placebo drug for 3 months.

Drug: Placebo - Cap

Interventions

Omega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA & 100 mg EPA)) or placebo capsules. DRUG

Participants will be randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules.

Omega-3 Polyunsaturated Fatty Acid Treatment Arm

Placebo - Cap DRUG

Participants will be randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals presenting to the emergency department (ED) within 24 hours of injury, who meet the American Congress of Rehabilitation Medicine (ACRM)'s definition of having mild traumatic brain injury (mTBI) will be eligible
• The ACRM defines mTBI as a traumatically-induced physiological disruption of brain function as a consequence of the head being struck, striking an object, or undergoing an acceleration/deceleration movement without direct external head trauma and resulting in at least one of the following:
• any period of loss of consciousness (LOC)
• any loss of memory for events immediately before or after the injury
• any alteration in mental state at the time of the injury (eg, feeling dazed, disoriented, or confused)
• focal neurological deficit(s) that may or may not be transient

You may not qualify if:

• GCS\<13 at any time during ED stay.
• Significant polytrauma including: bony fracture or solid organ injury
• Study medication cannot be administered within 24 hours of injury
• Patient cannot be relied on to complete follow-up (i.e. no reliable telephone number, substance dependence, homeless)
• Cannot communicate in English
• Take an anticoagulant (coumadin or a novel oral anticoagulant) daily
• Age less than 18 years or greater than 65 years
• Patients already taking fish oil supplements daily
• History of cognitive impairment
• Allergic to fish/fish oil
• Pregnant women (self-reported)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Brain Concussion

Interventions

Docosahexaenoic Acids; Fish Oils

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils

Results Point of Contact

• Title: Frederick Korley
• Organization: University of Michigan

korley@med.umich.edu

734 647-0261

Study Officials

• Frederick Korley, M.D., Ph.D.

  Department of Emergency Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 12, 2017
• First Posted: November 17, 2017
• Study Start: September 12, 2017
• Primary Completion: July 27, 2021
• Study Completion: July 27, 2021
• Last Updated: May 23, 2023
• Results First Posted: May 23, 2023

Record last verified: 2023-04

Locations

US (1)