A Study to Evaluate the Efficacy and Safety of TF0023 Spray on Subjects With Ischemic Strokes

Paused · Phase 2

Conditions studied: Ischemic Stroke

In brief

This is a phase 2, multicenter, randomized, double-blind (within dose), placebo controlled, parallel-group, dose-range finding study to evaluate the efficacy and safety of TF0023 spray versus placebo in functional improvement of patients with ischemic strokes under standard of care.

Key facts

Study ID

NCT02785120

Run by

Techfields Inc

People needed

225

Starts

2017-03-01

Expected to finish

2024-12-01

Last updated by the study team

2024-01-05

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female 18 to 85 years of age at the time of signing the informed consent form.
• Patient or patient's legal representative must understand and voluntarily sign the informed consent form prior to any study-related assessments/procedures are conducted.
• Able to adhere to the study visit schedule and other protocol requirements.
• A female of childbearing potential must have a negative serum at screening and negative urine pregnancy test prior to treatment with study therapy. In addition, sexually active females of childbearing potential must agree to use two of the following adequate forms of contraception methods simultaneously: oral, injectable or implantable hormonal contraception; tubal ligation; intrauterine device; barrier contraceptive with spermicide; or vasectomized partner for the duration of the study and the follow-up period. Males, including those who have had a vasectomy, must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with a female of childbearing potential for the duration of study and follow-up period.
• Must have a diagnosis of ischemic stroke and be stable enough to be randomized to treatment within 3 to 60 days after the onset of stroke symptoms. The stroke event needs to involve the middle cerebral artery (MCA) territory (cortical or subcortical) or posterior cerebral artery (PCA) territory with ischemic stroke confirmed by magnetic resonance imaging (MRI). Ischemic stroke is defined as death of an area of brain tissue (cerebral infarction) resulting from an inadequate supply of blood and oxygen to the brain.
• National Institute of Health Stroke Scale (NIHSS) score ≥3 but <22 at the time of screening, at least 3 days after the onset of stroke symptoms. Patient should not have shown rapid improvement (≥8 point decrease since the onset of stroke symptoms) or deterioration (≥4 point increase since the beginning of screening) in the NIHSS score from time of initial evaluation to randomization. The time from initial evaluation to initial screening evaluation will be at least 72 hours.
• New onset of extremity paresis on the affected side, defined as a score of 2 to 4 on the NIHSS Motor Arm (item 5) or Leg (item 6) question.
• Must be alert or drowsy but easily arousable as defined by a score of 0 to 1 on the NIHSS Level of Consciousness question (item 1).
• "Slow recovery" defined as change in NIHSS ≤1 point/3 days during the screening period.
• Able to participate in the evaluation process to the point of accurate assessment with/without help.
• Willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures.
• Must be willing to discontinue applying any topical preparations containing Vitamin A acids (including all-trans-retinoic acid [tretinoin], 13-cis-retinoic acid [isotretinoin], 9 cisretinoic acid [alitretinoin], vitamin A [retinol], retinal, and their derivatives) to any part of the body starting on Day 1 until study completion. (TF0023 may cause dry and/or itching skin. Curél Ultra Healing Lotion can be applied to the dry and/or itching skin).

You may not qualify if…

• Pregnant or lactating female.
• Any condition, including any significant medical or neuropsychiatric condition, including the presence of laboratory abnormalities, which in the judgment of the investigator places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study including, but not limited to:
• Aspartate transaminase (AST) or alanine transaminase (ALT) >3 × the upper limit of normal (ULN) at screening.
• Serum creatinine concentration >1.5 times the ULN at screening. Estimated glomerular filtration rate (GFR) <60 mL/min/1.73 m2 is exclusionary.
• Bilirubin or alkaline phosphatase level >2.5 × the ULN at screening.
• Glucose <50 mg/dL or >450 mg/dL despite adequate anti-hyperglycemic treatment.
• Platelet count <100 × 109/L.
• History of bacteremia or other serious bacterial or fungal infection requiring treatment with intravenous antibiotics within 84 days (12 weeks) prior to treatment with study therapy other than a treated urinary tract infection.
• Known infection with human immunodeficiency virus (HIV).
• Seropositive for hepatitis C or hepatitis B.
• Known history of seizures.
• Evidence of cerebral hemorrhage within the last 6 months or recent intracerebral hematomas detected by brain CT or MRI.
• Hypertension with systolic blood pressure (SBP) >185 mmHg or diastolic blood pressure (DBP) >120 mmHG (mean of 3 consecutive arm cuff readings over 20 to 30 minutes).
• High clinical suspicion of septic embolus.
• History of major trauma at time of stroke.
• History of malignancy within 5 years except basal cell or squamous cell carcinoma of the skin or remote history of cancer now considered cured or positive Pap smear with subsequent negative follow up.
• Known allergy to non-steroidal anti-inflammatory drugs (NSAIDs).
• Known allergy to both gadolinium and iodine based contrast agents for MRI preventing the ability to conduct either one of these procedures.
• Patient has received an investigational agent within 90 days or 5 half-lives, whichever is longer, prior to treatment with study therapy or planned participation in another therapeutic trial prior to the completion of this study.
• Patients with very light neurological symptoms (NIHSS score of <3) or with rapidly improving symptoms before the start of treatment.
• Patients with serious neurological disorders (NIHSS score ≥22) or serious consciousness disorders before the start of treatment.
• Patients with functional disorders (mRS score >2) before onset of the stroke.
• Patients who have been administered drugs that are not allowed to be administered concomitantly with any anti-thrombotic agents after onset of the stroke.
• Patients who are forbidden to undergo DTI-MRI.
• Patients with symptoms suggesting subarachnoid hemorrhage (SAH).

Where it is running

• Four Peaks Neurology — Scottsdale, Arizona, United States
• General Neuronology — Scottsdale, Arizona, United States
• Colorado Springs Neurological Associates — Colorado Springs, Colorado, United States
• CarePoint, P.C. dba Blue Sky Neurology — Englewood, Colorado, United States
• Tenet South Florida / Delray Medical Center — Delray Beach, Florida, United States
• The Neurology Research Group — Miami, Florida, United States
• Florida Hospital of Orlando — Orlando, Florida, United States
• Florida Hospital Orlando — Orlando, Florida, United States
• Central Baptist Hospital — Lexington, Kentucky, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Midwest Physicians Group — Kansas City, Missouri, United States
• Washington University School of Medicine - Center for Advanced Medicine (CAM) - Neuroscience Center — St Louis, Missouri, United States
• Renown Medical Group — Reno, Nevada, United States
• Hackensack Neurology Group — Hackensack, New Jersey, United States
• Icahn School of Medicine at Mount Sinai (ISMMS) - Institute for Critical Care Medicine — New York, New York, United States
• Neurology and Neuroscience Associates — Akron, Ohio, United States
• The Ohio State University Wexner Medical Center (OSUWMC) - Neurovascular Stroke Center — Columbus, Ohio, United States
• Providence Stroke Center — Portland, Oregon, United States
• Neurovascular Associates of Abington — Abington, Pennsylvania, United States
• Coastal Nurology — Port Royal, South Carolina, United States
• Chattanooga Neurology Associates - Memorial Office — Chattanooga, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Neurology Associates of Arlington, PA — Mansfield, Texas, United States
• VCU Medical Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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