NCT02053883

A Phase II/III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Cethrin in Subjects With Acute Cervical Spinal Cord Injury

Withdrawn Phase 2/Phase 3 Last updated 25 November 2014

What this trial tests

Phase 2/Phase 3 trial testing Cethrin (BA-210) in Spinal Cord Injury. Withdrawn.

Timeline

1 July 2015

Primary endpoint
1 May 2016

Quick facts

Lead sponsor	BioAxone BioSciences, Inc.
Phase	Phase 2/Phase 3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Start date	1 July 2015
Primary completion	1 May 2016

Drugs / interventions tested

• Cethrin (BA-210)
• Placebo

Conditions studied

• Spinal Cord Injury — all drugs for Spinal Cord Injury →

Sponsor

BioAxone BioSciences, Inc. — full company profile →

Who can join

Adults 18 to 62, any sex, with Spinal Cord Injury. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• American Spinal Injury Association (ASIA) Upper Extremity Motor Score Recovery
  Time frame: Baseline to 6 Months

Sponsor's own description

This is a multicenter, randomized, double-blind, placebo-controlled Phase IIb/III study designed to evaluate the efficacy and safety of Cethrin as a treatment for acute cervical spinal cord injury. During the trial, high and low doses of Cethrin will be compared with placebo.

Publications & conference data

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

1. Application of Hepatocyte Growth Factor for Acute Spinal Cord Injury: The Road from Basic Studies to Human Treatment.
   Kitamura K, Nagoshi N, Tsuji O, Matsumoto M, et al · · 2019 · cited 39× · PMID 30823442 · DOI 10.3390/ijms20051054
2. Mechanotransduction: Exploring New Therapeutic Avenues in Central Nervous System Pathology.
   Rocha DN, Carvalho ED, Relvas JB, Oliveira MJ, et al · · 2022 · cited 21× · PMID 35573316 · DOI 10.3389/fnins.2022.861613
3. Current status and prospects of regenerative medicine for spinal cord injury using human induced pluripotent stem cells: a review.
   Inoue M, Yamaguchi R, He CCJ, Ikeda A, et al · · 2023 · cited 14× · PMID 36970397 · DOI 10.21037/sci-2022-037
4. Cervical spinal cord injury: tailoring clinical trial endpoints to reflect meaningful functional improvements.
   Bond LM, McKerracher L. · · 2014 · cited 7× · PMID 25317162 · DOI 10.4103/1673-5374.139470
5. Spinal cord injury pharmacotherapy: Current research & development and competitive commercial landscape as of 2015.
   Guercio JR, Kralic JE, Marrotte EJ, James ML. · · 2019 · cited 5× · PMID 29485334 · DOI 10.1080/10790268.2018.1439803