Valproic AcId for Traumatic BRAin INjury Trial
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNorthwestern University
About this trial
The long-term goal of the clinical trial is to develop effective, safe, and easily administered life-saving treatments for patients with moderate to severe traumatic brain injury (TBI).
Patients with moderate to severe TBI will randomly receive either:
1. Standard of care treatment and normal saline 2. Standard of care treatment and one dose of valproic acid (VPA) at a lower dose or a higher dose
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female between the ages of 18 and 65 years.
Body Mass Index between 18 kg/m2 and 35 kg/m2.
Females must be surgically sterilized, postmenopausal, or have a negative urine pregnancy test.
Moderate to severe TBI: Glasgow Coma Scale (GCS) 3-12.
Disqualifiers
Persons with known history of adverse reactions to VPA
Persons with known history of hepatitis B or C or clinical history of hepatic dysfunction, pancreatitis, or renal insufficiency.
Persons with a known history of thrombocytopenia.
Persons with platelet count less than 100,000 per microliter of blood.
Trial design
Design model
Parallel
Treatments tested in this trial
Valproic Acid (VPA)
DrugVPA (in 250 ml 0.9% sodium chloride solution)
Standard of care treatment + normal saline
Other interventionStandard of care treatment + normal saline (0.9% sodium chloride solution) vehicle (250 ml)
Treatment groups
432 Participants
are divided into 2 treatment groupsGroup A: ControlPlacebo comparator 1 intervention
Group B: ExperimentalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Extended Glasgow Outcome Scale (GOS-E)
Scoring values range from 1 to 8 with higher scores representing a better outcome. 1 indicates death, 2 indicates a vegetative state, 3 or 4 indicates severe disability, 5 or 6 indicates moderate disability, and 7 or 8 indicates good recovery.
Time frame
3 months post-injurySecondary outcomes
1
Hemorrhagic progression of the contusion (HPC)
We will quantify HPC as the change in volume of the largest contiguous brain lesion in mm. This will be measured through a comparison of the initial and the follow-up CT scan.
Time frame
First 24 hours post-injury as measured by a CT scan2
Disability Rating Score (DRS)
This scale includes eight categories: A. Eye opening (0-5), B. Communication ability (0-4), C. Motor response (0-5), D. Feeding - cognitive ability only (0-3), E. Toileting - cognitive ability only (0-3), F. Grooming - cognitive ability only (0-3), G. Level of functioning - physical, mental, emotional or social function (0-5) and H. "Employability" - a full time worker, homemaker, or student (0-3). Higher scores in each category mean a worse outcome.
Time frame
Discharge or day 7 and 3 months post-injuryOther outcomes
1
Disability Rating Score (DRS)
This scale includes eight categories: A. Eye opening (0-5), B. Communication ability (0-4), C. Motor response (0-5), D. Feeding - cognitive ability only (0-3), E. Toileting - cognitive ability only (0-3), F. Grooming - cognitive ability only (0-3), G. Level of functioning - physical, mental, emotional or social function (0-5) and H. "Employability" - a full time worker, homemaker, or student (0-3). Higher scores in each category mean a worse outcome.
Time frame
6 months post-injury2
Extended Glasgow Outcome Scale (GOS-E)
Scoring values range from 1 to 8 with higher scores representing a better outcome. 1 indicates death, 2 indicates a vegetative state, 3 or 4 indicates severe disability, 5 or 6 indicates moderate disability, and 7 or 8 indicates good recovery.
Time frame
6 months post injury3
Glasgow Coma Scale (GCS)
Evaluates three behavior responses: eye opening, best verbal and best motor. The following scoring is associated with responses: Eye opening response - Spontaneously 4, To speech 3, To pain 2 and No response 1; Best verbal - Oriented to time/place/person 5, Confused 4, Inappropriate words 3, Incomprehensible sounds 2 and No response 1; and Best motor response - Obeys commands 6, Moves to localized pain 5, Flexion withdrawal from pain 4, Abnormal flexion 3, Abnormal extension 2 and No response 1. The scoring is totaled with higher values associated with better response. Total Score: Best response=15, Comatose client=8 or less, and Totally unresponsive=3.
Time frame
24 hours post-injurySponsors and contacts
Click on the lead sponsor to view all of their trials.
Northwestern University
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: