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

NCT02785120 | Suspended Phase 2 DMC FDA Drug

• 1 other identifier: TF-TF0023-21
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 24

Brief Summary

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.

Conditions

Ischemic Stroke

Keywords

Phase 2; Efficacy; Safety; Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint is the change from baseline in the mRS score for all randomized patients at Week 16 in Part A and Part B.

  The mRS score measures the patient's functional level of activity and is dichotomized as a favorable outcome (score = 0 - 2) versus unfavorable (score ≥2). The mRS score ranges from 0 (no symptoms) to 6 (death) as follows: 0 = No symptoms at all 1. = No significant disability despite symptoms; able to carry out all usual duties and activities 2. = Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. = Moderate disability requiring some help, but able to walk unassisted 4. = Moderate severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. 5. = Severe disability; bedridden, incontinent, and requiring constant nursing care and attention. 6. = Dead.

  16 weeks of treatment

Secondary Outcomes (18)

• Death due to any cause after signing the informed consent form through Week 16 and Week 32.

  16 and 32 weeks of treatment

• Recurrent stroke after signing the informed consent form through Week 16 and Week 32.

  16 and 32 weeks of treatment

• NIHSS score changes after signing the informed consent form through Week 16 and Week 32.

  0, 16 and 32 weeks of treatment

• Barthel Index (BI) changes after signing the informed consent form through Week 16 and Week 32.

  0, 16 and 32 weeks of treatment

• Extended Glasgow Outcome Scale (GOS-E) changes after signing the informed consent form through Week 16 and Week 32.

  0, 16 and 32 weeks of treatment

Study Arms (3)

High dose

EXPERIMENTAL

75 patients will be randomized to active or placebo treatment in a 2:1 ratio (TF0023 \[50 patients\] and placebo \[25 patients\]). Each patient enrolled in Group A will receive study treatment in a double-blind manner for 16 weeks starting between 3 and 60 days after the onset of stroke symptoms (Day 1 of the study).

Drug: TF0023

Middle dose

EXPERIMENTAL

75 patients will be randomized to active or placebo treatment in a 2:1 ratio (TF0023 \[50 patients\] and placebo \[25 patients\]). Each patient enrolled in Group A will receive study treatment in a double-blind manner for 16 weeks starting between 3 and 60 days after the onset of stroke symptoms (Day 1 of the study).

Drug: TF0023

Low dose

EXPERIMENTAL

75 patients will be randomized to active or placebo treatment in a 2:1 ratio (TF0023 \[50 patients\] and placebo \[25 patients\]). Each patient enrolled in Group A will receive study treatment in a double-blind manner for 16 weeks starting between 3 and 60 days after the onset of stroke symptoms (Day 1 of the study).

Drug: TF0023

Interventions

TF0023 DRUG

TF0023 is a new Investigational drug as a topical spray as an anti thrombosis drug, indicated for relief of the signs and symptoms and functional improvement of patients with ischemic strokes.

Also known as: Active drug

High dose; Low dose; Middle dose

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• Techfields Inc: lead

Study Sites (24)

Four Peaks Neurology

Scottsdale, Arizona, 85258, United States

Location

General Neuronology

Scottsdale, Arizona, 85258, United States

Location

Colorado Springs Neurological Associates

Colorado Springs, Colorado, 80907, United States

Location

CarePoint, P.C. dba Blue Sky Neurology

Englewood, Colorado, 80113, United States

Location

Tenet South Florida / Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

The Neurology Research Group

Miami, Florida, 33176, United States

Location

Florida Hospital of Orlando

Orlando, Florida, 32803, United States

Location

Florida Hospital Orlando

Orlando, Florida, 32803, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Midwest Physicians Group

Kansas City, Missouri, 64132, United States

Location

Washington University School of Medicine - Center for Advanced Medicine (CAM) - Neuroscience Center

St Louis, Missouri, 63110-1032, United States

Location

Renown Medical Group

Reno, Nevada, 89502, United States

Location

Hackensack Neurology Group

Hackensack, New Jersey, 07601, United States

Location

Icahn School of Medicine at Mount Sinai (ISMMS) - Institute for Critical Care Medicine

New York, New York, 10029-6508, United States

Location

Neurology and Neuroscience Associates

Akron, Ohio, 44320, United States

Location

The Ohio State University Wexner Medical Center (OSUWMC) - Neurovascular Stroke Center

Columbus, Ohio, 43210, United States

Location

Providence Stroke Center

Portland, Oregon, 97225-6652, United States

Location

Neurovascular Associates of Abington

Abington, Pennsylvania, 19001, United States

Location

Coastal Nurology

Port Royal, South Carolina, 29935, United States

Location

Chattanooga Neurology Associates - Memorial Office

Chattanooga, Tennessee, 37404-1154, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Neurology Associates of Arlington, PA

Mansfield, Texas, 76063, United States

Location

VCU Medical Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Bulk Drugs

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Chongxi Yu, Ph.D

  Techfields Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 27, 2016
• Study Start: March 1, 2017
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (24)