Trial Outcomes & Findings for Efficacy and Safety of Trans Sodium Crocetinate (TSC) for Treatment of Suspected Stroke (NCT NCT03763929)

Last Updated: 2021-06-18

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

90 days

Results posted on

2021-06-18

Participant Flow

Participant milestones

Participant milestones
Measure	Trans Sodium Crocetinate 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. Trans-Sodium Crocetinate: 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.	Placebo 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. Placebo: The study drug kit containing placebo (sterile saline for Injection) will be prepared and injected by the unblinded paramedic on the ambulance.
Overall Study STARTED	2	4
Overall Study COMPLETED	2	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trans Sodium Crocetinate n=2 Participants 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. Trans-Sodium Crocetinate: 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.	Placebo n=4 Participants 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. Placebo: The study drug kit containing placebo (sterile saline for Injection) will be prepared and injected by the unblinded paramedic on the ambulance.	Total n=6 Participants Total of all reporting groups
Age, Continuous	74.0 years n=5 Participants	63.8 years n=7 Participants	67.2 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Outcome measures

Outcome measures
Measure	Trans Sodium Crocetinate n=2 Participants 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. Trans-Sodium Crocetinate: 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.	Placebo n=3 Participants 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. Placebo: The study drug kit containing placebo (sterile saline for Injection) will be prepared and injected by the unblinded paramedic on the ambulance.
Global Disability Level on the Modified Rankin Score (mRS)	2.5 score on a scale Interval 2.0 to 3.0	3.0 score on a scale Interval 0.0 to 3.0

Adverse Events

Trans Sodium Crocetinate

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Trans Sodium Crocetinate n=2 participants at risk 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. Trans-Sodium Crocetinate: 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.	Placebo n=4 participants at risk 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. Placebo: The study drug kit containing placebo (sterile saline for Injection) will be prepared and injected by the unblinded paramedic on the ambulance.
Nervous system disorders Hemorrhagic Transformation of Infarct	50.0% 1/2 • Number of events 1 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.	0.00% 0/4 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.
Vascular disorders Hypotension	0.00% 0/2 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.	25.0% 1/4 • Number of events 1 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/2 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.	25.0% 1/4 • Number of events 1 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.
Nervous system disorders Cerebral Edema	0.00% 0/2 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.	50.0% 2/4 • Number of events 2 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.
Infections and infestations Pneumonia	0.00% 0/2 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.	25.0% 1/4 • Number of events 1 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.

Other adverse events

Additional Information

Clinical Operations

Diffusion Pharmaceuticals Inc

Phone: 434-220-0718

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Trans Sodium Crocetinate n=2 participants at risk 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. Trans-Sodium Crocetinate: 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.	Placebo n=4 participants at risk 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. Placebo: The study drug kit containing placebo (sterile saline for Injection) will be prepared and injected by the unblinded paramedic on the ambulance.
Blood and lymphatic system disorders Hypochromic Anemia	0.00% 0/2 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.	25.0% 1/4 • Number of events 1 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.
Gastrointestinal disorders Constipation	0.00% 0/2 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.	50.0% 2/4 • Number of events 2 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.
Gastrointestinal disorders Nausea	0.00% 0/2 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.	25.0% 1/4 • Number of events 1 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.
General disorders Pain	0.00% 0/2 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.	25.0% 1/4 • Number of events 1 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.
General disorders Pyrexia	0.00% 0/2 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.	25.0% 1/4 • Number of events 1 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.
Injury, poisoning and procedural complications Ankle Fracture	0.00% 0/2 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.	25.0% 1/4 • Number of events 1 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.
Injury, poisoning and procedural complications Fall	0.00% 0/2 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.	25.0% 1/4 • Number of events 1 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/2 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.	50.0% 2/4 • Number of events 2 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.
Nervous system disorders Headache	0.00% 0/2 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.	25.0% 1/4 • Number of events 1 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.
Nervous system disorders Hemiparesis	0.00% 0/2 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.	25.0% 1/4 • Number of events 1 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.
Psychiatric disorders Agitation	0.00% 0/2 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.	25.0% 1/4 • Number of events 1 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.
Psychiatric disorders Anxiety	0.00% 0/2 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.	25.0% 1/4 • Number of events 1 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.
Renal and urinary disorders Urinary Retention	50.0% 1/2 • Number of events 1 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.	0.00% 0/4 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.	25.0% 1/4 • Number of events 1 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.
Respiratory, thoracic and mediastinal disorders Increased Bronchial Secretion	0.00% 0/2 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.	25.0% 1/4 • Number of events 1 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.
Skin and subcutaneous tissue disorders Pruritis	0.00% 0/2 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.	25.0% 1/4 • Number of events 1 • Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.