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NCT03229031

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Safety and Efficacy of ES135 in Subjects With Spinal Cord Injury

Suspended Phase 3 Last updated 8 May 2024
What this trial tests

Phase 3 trial testing ES135 in Spinal Cord Injuries in 160 participants. Suspended.

Timeline
7 March 2018
Primary endpoint
31 December 2024
31 December 2026

Quick facts

Lead sponsorEusol Biotech Co., Ltd.
PhasePhase 3
StatusSuspended
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment160
Start date7 March 2018
Primary completion31 December 2024
Estimated completion31 December 2026
Sites3 locations across Taiwan

Drugs / interventions tested

Conditions studied

Sponsor

Eusol Biotech Co., Ltd. — full company profile →

Who can join

Adults 15 to 65, any sex, with Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To demonstrate the superior effect of ES135 combined with spinal cord repairing surgery, compared to a placebo control with spinal cord repairing surgery, on post-surgery motor function recovery as measured by the changes from baseline of ISNCSCI Motor Scores in subjects

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Fibroblast growth factor signaling in axons: from development to disease.
    Tomé D, Dias MS, Correia J, Almeida RD. · · 2023 · cited 22× · PMID 37845690 · DOI 10.1186/s12964-023-01284-0
  2. Established and Emerging Therapies in Acute Spinal Cord Injury.
    Gadot R, Smith DN, Prablek M, Grochmal JK, et al · · 2022 · cited 19× · PMID 35793931 · DOI 10.14245/ns.2244176.088
  3. Functional improvement in chronic human spinal cord injury: Four years after acidic fibroblast growth factor.
    Ko CC, Tu TH, Wu JC, Huang WC, et al · · 2018 · cited 19× · PMID 30139947 · DOI 10.1038/s41598-018-31083-4
  4. Combining Therapeutic Strategies to Treat the Injured Spinal Cord: A Translational Perspective.
    Sherman BC, Schmidt Read M, Hoh DJ, Guest JD, et al · · 2025 · cited 2× · PMID 40929022 · DOI 10.1177/08977151251371710

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Other recruiting trials for Spinal Cord Injuries

Currently open trials in the same condition.

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Data sources for this page

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/NCT03229031.

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