A Phase 2 interventional study of Trans-Sodium Crocetinate and Placebo in Stroke, Acute, sponsored by Diffusion Pharmaceuticals Inc. Terminated at 2 sites in United States. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-06-18.
Sponsored by Diffusion Pharmaceuticals Inc · Phase 2, Interventional, and Treatment
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.
This is a multicenter, randomized, placebo-controlled, double-blind, parallel group trial of intravenous trans sodium crocetinate (TSC) initiated by emergency medical service (EMS) responders in the field within 2 hours of symptom onset in 160 subjects with acute stroke. The primary objectives of the study are to evaluate the efficacy and safety of field-initiated TSC in improving the long-term functional outcome of subjects with acute stroke.
Subjects with acute stroke will be identified and screened in the ambulance by (EMS) responders who have received training in basic and advanced cardiac life support, stroke recognition, and specific procedures relevant to the proposed study. The EMS responders will contact a Study Neurologist, who will enroll eligible stroke patients into the study. Effort will be made to obtain prospective informed consent in the ambulance when deemed to be feasible. If not feasible, subjects will be enrolled under regulations for exception from explicit informed consent (EFIC) in emergency research circumstances, after public disclosure and community consultation. Written informed consent to continue in the study is obtained from subjects or their legally authorized representatives as soon as possible after hospital arrival.
EMS responders will deliver the single, field, bolus dose of study agent, TSC at 0.25 mg/kg or matched placebo, followed after hospital arrival by standard of care (SOC). No additional study drug will be administered in the hospital. Follow-up assessments will be performed at Emergency Department (ED) arrival, 24 hours, 48 hours, Day 4, Day 30, and Day 90. The study will be performed at up to 30 receiving hospital sites in Los Angeles County, CA, and central Virginia.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 6 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Diffusion Pharmaceuticals Inc is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Exclusion Criteria:
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
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
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
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)
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
| Milestone | Trans Sodium Crocetinate | Placebo |
|---|---|---|
| Started | 2 | 4 |
| Completed | 2 | 4 |
| Not completed | 0 | 0 |
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
| score on a scale | Trans Sodium Crocetinate | Placebo |
|---|---|---|
| Global Disability Level on the Modified Rankin Score (mRS) | 2.5 (2 to 3) | 3.0 (0 to 3) |
Collected over Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Trans Sodium Crocetinate | 0/2 (0%) | 1/2 (50%) | 1/2 (50%) |
| Placebo | 1/4 (25%) | 2/4 (50%) | 4/4 (100%) |
| Event | Trans Sodium Crocetinate | Placebo |
|---|---|---|
| Hemorrhagic Transformation of InfarctNervous system disorders | 1/2 | 0/4 |
| Cerebral EdemaNervous system disorders | 0/2 | 2/4 |
| HypotensionVascular disorders | 0/2 | 1/4 |
| Acute Respiratory FailureRespiratory, thoracic and mediastinal disorders | 0/2 | 1/4 |
| PneumoniaInfections and infestations | 0/2 | 1/4 |
| Event | Trans Sodium Crocetinate | Placebo |
|---|---|---|
| ConstipationGastrointestinal disorders | 0/2 | 2/4 |
| HyperglycaemiaMetabolism and nutrition disorders | 0/2 | 2/4 |
| Urinary RetentionRenal and urinary disorders | 1/2 | 0/4 |
| Hypochromic AnemiaBlood and lymphatic system disorders | 0/2 | 1/4 |
| NauseaGastrointestinal disorders | 0/2 | 1/4 |
| PainGeneral disorders | 0/2 | 1/4 |
| PyrexiaGeneral disorders | 0/2 | 1/4 |
| Ankle FractureInjury, poisoning and procedural complications | 0/2 | 1/4 |
| FallInjury, poisoning and procedural complications | 0/2 | 1/4 |
| HeadacheNervous system disorders | 0/2 | 1/4 |
| Age, Continuous(years) | Trans Sodium Crocetinate | Placebo | Total |
|---|---|---|---|
| Mean | 74.0 (73 to 75) | 63.8 (45 to 80) | 67.2 (45 to 80) |
| Sex: Female, Male(Participants) | Trans Sodium Crocetinate | Placebo | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 1 | 2 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Trans Sodium Crocetinate | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 2 | 3 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Trans Sodium Crocetinate | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 2 | 3 | 5 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Trans Sodium Crocetinate | Placebo | Total |
|---|---|---|---|
| United States | 2 | 4 | 6 |
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Diffusion Pharmaceuticals Inc