Efficacy and Safety of Trans Sodium Crocetinate (TSC) for Treatment of Suspected Stroke

NCT03763929 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 100-501
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

This study will assess the potential efficacy and safety of TSC as early treatment for both ischemic and hemorrhagic stroke when administered while subject is in ambulance being transported to hospital.

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (1)

• Global Disability Level on the Modified Rankin Score (mRS)

  Modified Rankin Scale (mRS) is a measure of global disability. Total scale range is 0-6, with lower values indicating better outcomes. 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 without assistance 4. = Moderately 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

  90 days

Study Arms (2)

Trans Sodium Crocetinate

EXPERIMENTAL

Trans sodium crocetinate (TSC) will be administered intravenously as a bolus to subjects randomized to experimental drug. The bolus dose will consist of 0.25 mg/kg of TSC based on the estimated subject weight.

Drug: Trans-Sodium Crocetinate

Placebo

PLACEBO COMPARATOR

The placebo consists of commercially available sterile saline. Placebo will be administered intravenously as a bolus to subjects randomized to placebo. The volume of sterile saline will be based on the estimated subject weight.

Other: Placebo

Interventions

Trans-Sodium Crocetinate DRUG

In the study drug kit containing the experimental drug (TSC), TSC will be reconstituted with the Sterile Water for Injection (USP) supplied in the same kit. There will be an unblinded paramedic who will reconstitute and inject the TSC on the ambulance.

Also known as: TSC

Trans Sodium Crocetinate

Placebo OTHER

The study drug kit containing placebo (sterile saline for Injection) will be prepared and injected by the unblinded paramedic on the ambulance.

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-85, inclusive
• Last known well time 15-120 minutes before anticipated study drug injection
• Suspected stroke identified by the LAPSS
• Moderate to severe motor deficit, with Los Angeles Motor Scale (LAMS) 2 or higher
• No seizure

You may not qualify if:

• Coma
• Rapidly improving neurologic deficit
• History of seizures or epilepsy
• Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations
• SBP \< 90 or \> 220
• Major head trauma in the last 24 hours
• Recent stroke within 30 days
• Known to be pregnant or lactating

Sponsors & Collaborators

• Diffusion Pharmaceuticals Inc: lead
• University of California, Los Angeles: collaborator
• University of Virginia: collaborator

Study Sites (2)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• Zachrison KS, Amati V, Schwamm LH, Yan Z, Nielsen V, Christie A, Reeves MJ, Sauser JP, Lomi A, Onnela JP. Influence of Hospital Characteristics on Hospital Transfer Destinations for Patients With Stroke. Circ Cardiovasc Qual Outcomes. 2022 May;15(5):e008269. doi: 10.1161/CIRCOUTCOMES.121.008269. Epub 2022 Apr 4.

  PMID: 35369714 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

trans-sodium crocetinate

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The trial was early terminated after 6 subjects were enrolled due to logistical issues surrounding the COVID-19 pandemic. Due to this low enrollment number, the statistical plan outlined in the protocol was not utilized. Data listings and tables were instead created, which captured data on the 6 subjects in a descriptive manner. Therefore, no substantive conclusions could be drawn.

Results Point of Contact

• Title: Clinical Operations
• Organization: Diffusion Pharmaceuticals Inc

clinicaltrials@diffusionpharma.com

434-220-0718

Study Officials

• Andrew Southerland, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Nerses Sanossian, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

• Karen Johnston, MD

  University of Virginia

  STUDY CHAIR

• Jeffrey Saver, MD

  University of California, Los Angeles

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: TSC injections will be prepared and injected by unblinded personnel on each ambulance. All other study personnel will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized, placebo-controlled, double-blind, parallel group

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 4, 2018
• Study Start: August 22, 2019
• Primary Completion: October 19, 2020
• Study Completion: October 19, 2020
• Last Updated: June 18, 2021
• Results First Posted: June 18, 2021

Record last verified: 2020-12

Locations

US (2)