Adults 40 to 85, any sex, with Stroke, Acute. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Global Disability Level on the Modified Rankin Score (mRS)Primary· 90 days
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. = S
Group
Value
95% CI
Trans Sodium Crocetinate
2.5
2 – 3
Placebo
3.0
0 – 3
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data were collected from the start of study drug administration through the end of the Day 90 follow-up visit..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04808622 — Safety and Efficacy of Trans Sodium Crocetinate (TSC) in Enhancing Tissue Oxygen Levels in Healthy Volunteers
· Phase 1
· completed
Other recruiting trials for Stroke, Acute
Currently open trials in the same condition.
NCT06825897 — Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiograp
· NA
· recruiting
NCT06658197 — Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke
· Phase 3
· recruiting
NCT07253870 — Comperative Effects of Transcutaneous Auricular and Cervical Vagus Nerve Stimulation in Subacute Stroke Patients
· NA
· recruiting
NCT06941753 — Off-script Diagnosis & Differential Diagnosis (D&D) Training and Residents' Stroke Knowledge
· NA
· recruiting
NCT06123650 — Post Stroke Dysphagia: Effect of Adding rTMS to Conventional Therapy on the Prevalence of Pneumonia.
· NA
· recruiting
Other Diffusion Pharmaceuticals Inc trials
Trials by the same sponsor.
NCT05079126 — Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease
· Phase 2
· terminated
NCT05036980 — Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Trans Sodium Crocetinate in Healthy Volunteers Exercisi
· Phase 1
· completed
NCT04808622 — Safety and Efficacy of Trans Sodium Crocetinate (TSC) in Enhancing Tissue Oxygen Levels in Healthy Volunteers
· Phase 1
· completed
NCT04573322 — Safety and Efficacy of Trans Sodium Crocetinate (TSC) in SARS-CoV-2 (COVID-19) Infected Subjects
· Phase 1, PHASE2
· completed
NCT03393000 — Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects
· Phase 3
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Diffusion Pharmaceuticals Inc
Last refreshed: 18 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03763929.