Who is sponsoring NCT00610337?

NCT00610337 is sponsored by BioAxone BioSciences, Inc..

What drugs are being tested in NCT00610337?

Interventions in NCT00610337: Cethrin® (BA-210), placebo.

What condition does NCT00610337 study?

NCT00610337 studies Acute Cervical Spinal Cord Injury.

Is NCT00610337 still recruiting?

NCT00610337 is currently withdrawn. Last updated 16 January 2014.

Last reviewed 2014-01-16 · How we verify

NCT00610337

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase IIb, Double-Blind, Randomized, Placebo Controlled, Multicenter Study to Assess the Safety and Efficacy of Intraoperative Epidural Cethrin® in Adult Subjects With Acute Cervical Spinal Cord Injury

Withdrawn Phase 2 Last updated 16 January 2014

What this trial tests

Phase 2 trial testing Cethrin® (BA-210) in Acute Cervical Spinal Cord Injury. Withdrawn.

Quick facts

Lead sponsor	BioAxone BioSciences, Inc.
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment

Drugs / interventions tested

Cethrin® (BA-210) — full drug profile →
placebo

Conditions studied

Acute Cervical Spinal Cord Injury — all drugs for Acute Cervical Spinal Cord Injury →

Sponsor

BioAxone BioSciences, Inc. — full company profile →

Who can join

Adults 18 to 62, any sex, with Acute Cervical 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.

Mean change in ASIA motor score
Time frame: week 26
Death
Time frame: 12 months
Serious Adverse Events
Time frame: 12 months

Sponsor's own description

This is a multicenter, randomized, double-blind, placebo-controlled, Phase IIb study to be conducted in North America and Europe and will include male and female subjects with acute cervical SCI, 18 to 62 years of age, who receive clinical trial material (CTM) within 72 hours of injury. This study is being undertaken to evaluate and confirm the safety and efficacy of CETHRIN®. This adaptive study has been designed to efficiently identify the safest and most effective dose in Phase IIb which will be evaluated in a future Phase III study. Given the current lack of effective treatments for SCI, an improvement in motor ability or activities of daily living in these subjects would be a great advancement in the treatment of SCI.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00610337 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BioAxone BioSciences, Inc.
Last refreshed: 16 January 2014

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/NCT00610337.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing