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Multi-Drug Therapy for Traumatic Brain Injury (APT-TBI-01 Trial)
APT-TBI-01 Trial Summary
This trial tests if an experimental drug treatment can improve recovery from TBI compared to a control group. FDA-approved drugs are used "off-label" to see if they can help.
APT-TBI-01 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.APT-TBI-01 Trial Design
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Who is running the clinical trial?
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- My GFAP blood level is between 100 and 15,000 pg/ml.I am currently taking or cannot take the trial drug due to health reasons.I am between 18 and 65 years old.My liver enzymes are not more than three times the normal limit.I have a blood clot between my skull and brain.I am using effective birth control and can continue to do so during the trial.My kidney function is reduced.I have had a brain injury shown on a CT scan.I am willing and able to follow all study requirements.I cannot swallow pills.
- Group 1: Intervention 1: Atorvastatin calcium (ATOR)
- Group 2: Intervention 2: Minocycline hydrochloride (MINO)
- Group 3: Intervention 3: Candesartan cilexetil (CAND)
- Group 4: Matching Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this investigation allow for individuals over 30 to take part?
"This trial is accepting volunteers aged 18 years and over, yet below 65."
Does Intervention 1 comply with the regulations established by the FDA?
"Due to limited clinical evidence supporting Intervention 1's efficacy, our team at Power has rated its safety a 2 on the scale of 1-3."
Are there opportunities for me to participate in this experiment?
"Eligible candidates for this trial should have suffered a traumatic brain injury and must be between the ages of 18 to 65. In total, 672 patients will be accepted into the study."
Are researchers still taking on participants for this experiment?
"As evidenced on clinicaltrials.gov, this trial is not currently accepting participants; the study was first posted in August 30th 2023 and has most recently been updated April 12th 2023. However, there are 955 different medical trials actively recruiting now."
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