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

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ClinicalTrials.gov Identifier: NCT03763929
Recruitment Status : Terminated (The study was stopped due to lack of meaningful enrollment due to the COVID-19 pandemic.)
First Posted : December 4, 2018
Results First Posted : June 18, 2021
Last Update Posted : June 18, 2021
Sponsor:
Collaborators:
University of California, Los Angeles
University of Virginia
Information provided by (Responsible Party):
Diffusion Pharmaceuticals Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Stroke, Acute
Interventions Drug: Trans-Sodium Crocetinate
Other: Placebo
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Trans Sodium Crocetinate Placebo
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 2 4
Completed 2 4
Not Completed 0 0
Arm/Group Title Trans Sodium Crocetinate Placebo Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 2 4 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants 4 participants 6 participants
74.0
(73 to 75)
63.8
(45 to 80)
67.2
(45 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 4 participants 6 participants
Female
1
  50.0%
2
  50.0%
3
  50.0%
Male
1
  50.0%
2
  50.0%
3
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 4 participants 6 participants
Hispanic or Latino
0
   0.0%
1
  25.0%
1
  16.7%
Not Hispanic or Latino
2
 100.0%
3
  75.0%
5
  83.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 4 participants 6 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
  25.0%
1
  16.7%
White
2
 100.0%
3
  75.0%
5
  83.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 4 participants 6 participants
2 4 6
1.Primary Outcome
Title Global Disability Level on the Modified Rankin Score (mRS)
Hide Description

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
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trans Sodium Crocetinate Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 2 3
Median (Full Range)
Unit of Measure: score on a scale
2.5
(2 to 3)
3.0
(0 to 3)
Time Frame Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Trans Sodium Crocetinate Placebo
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Trans Sodium Crocetinate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)      1/4 (25.00%)    
Hide Serious Adverse Events
Trans Sodium Crocetinate Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/2 (50.00%)      2/4 (50.00%)    
Infections and infestations     
Pneumonia * 1  0/2 (0.00%)  0 1/4 (25.00%)  1
Nervous system disorders     
Hemorrhagic Transformation of Infarct * 1  1/2 (50.00%)  1 0/4 (0.00%)  0
Cerebral Edema * 1  0/2 (0.00%)  0 2/4 (50.00%)  2
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Failure * 1  0/2 (0.00%)  0 1/4 (25.00%)  1
Vascular disorders     
Hypotension * 1  0/2 (0.00%)  0 1/4 (25.00%)  1
1
Term from vocabulary, MedDRA (Unspecified)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Trans Sodium Crocetinate Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/2 (50.00%)      4/4 (100.00%)    
Blood and lymphatic system disorders     
Hypochromic Anemia * 1  0/2 (0.00%)  0 1/4 (25.00%)  1
Gastrointestinal disorders     
Constipation * 1  0/2 (0.00%)  0 2/4 (50.00%)  2
Nausea * 1  0/2 (0.00%)  0 1/4 (25.00%)  1
General disorders     
Pain * 1  0/2 (0.00%)  0 1/4 (25.00%)  1
Pyrexia * 1  0/2 (0.00%)  0 1/4 (25.00%)  1
Injury, poisoning and procedural complications     
Ankle Fracture * 1  0/2 (0.00%)  0 1/4 (25.00%)  1
Fall * 1  0/2 (0.00%)  0 1/4 (25.00%)  1
Metabolism and nutrition disorders     
Hyperglycaemia * 1  0/2 (0.00%)  0 2/4 (50.00%)  2
Nervous system disorders     
Headache * 1  0/2 (0.00%)  0 1/4 (25.00%)  1
Hemiparesis * 1  0/2 (0.00%)  0 1/4 (25.00%)  1
Psychiatric disorders     
Agitation * 1  0/2 (0.00%)  0 1/4 (25.00%)  1
Anxiety * 1  0/2 (0.00%)  0 1/4 (25.00%)  1
Renal and urinary disorders     
Urinary Retention * 1  1/2 (50.00%)  1 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  0/2 (0.00%)  0 1/4 (25.00%)  1
Increased Bronchial Secretion * 1  0/2 (0.00%)  0 1/4 (25.00%)  1
Skin and subcutaneous tissue disorders     
Pruritis * 1  0/2 (0.00%)  0 1/4 (25.00%)  1
1
Term from vocabulary, MedDRA (Unspecified)
*
Indicates events were collected by non-systematic assessment
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Operations
Organization: Diffusion Pharmaceuticals Inc
Phone: 434-220-0718
EMail: clinicaltrials@diffusionpharma.com
Layout table for additonal information
Responsible Party: Diffusion Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT03763929    
Other Study ID Numbers: 100-501
First Submitted: December 3, 2018
First Posted: December 4, 2018
Results First Submitted: May 24, 2021
Results First Posted: June 18, 2021
Last Update Posted: June 18, 2021