NCT00500812

A Phase I/IIa Dose-Ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BA-210 and the Neurological Status of Patients Following Administration of a Single Extradural Application of Cethrin During Surgery for Acute Thoracic and Cervical Spinal Cord Injury

Completed Phase 1/Phase 2 Last updated 15 March 2016

What this trial tests

Phase 1/Phase 2 trial testing Cethrin in Spinal Cord Injury in 48 participants. Completed in 1 February 2009.

Timeline

1 February 2005

Primary endpoint
1 December 2008

1 February 2009

Quick facts

Lead sponsor	Vertex Pharmaceuticals Incorporated
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	1 February 2005
Primary completion	1 December 2008
Estimated completion	1 February 2009
Sites	8 locations across United States, Canada

Drugs / interventions tested

• Cethrin — full drug profile →

Conditions studied

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

Sponsor

Vertex Pharmaceuticals Incorporated — full company profile →

Who can join

Adults 16 to 70, 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.

• The primary goal of this study is to determine the safety and tolerability of Cethrin when administered in conjunction with fibrin sealant to the dura mater of the spinal cord.
  Time frame: Prestudy, 24-72 hrs, 6 weeks, 3, 6 & 12 months

Sponsor's own description

This trial is a multi-center, open-label, dose-escalation study designed to evaluate the safety, tolerability and pharmacokinetics of Cethrin in two types of spinal cord injury patients: those with a complete cervical injury or a complete thoracic injury. Dose levels from 0.3 mg - 9 mg of Cethrin will be administered.

Publications & conference data

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

1. Traumatic Brain Injuries: Pathophysiology and Potential Therapeutic Targets.
   Ng SY, Lee AYW. · · 2019 · cited 572× · PMID 31827423 · DOI 10.3389/fncel.2019.00528
2. Inflammogenesis of Secondary Spinal Cord Injury.
   Anwar MA, Al Shehabi TS, Eid AH. · · 2016 · cited 316× · PMID 27147970 · DOI 10.3389/fncel.2016.00098
3. Concise Review: Bridging the Gap: Novel Neuroregenerative and Neuroprotective Strategies in Spinal Cord Injury.
   Ahuja CS, Fehlings M. · · 2016 · cited 160× · PMID 27130222 · DOI 10.5966/sctm.2015-0381
4. Drug delivery, cell-based therapies, and tissue engineering approaches for spinal cord injury.
   Kabu S, Gao Y, Kwon BK, Labhasetwar V. · · 2015 · cited 133× · PMID 26343846 · DOI 10.1016/j.jconrel.2015.08.060
5. Rho-kinase inhibitors as therapeutics: from pan inhibition to isoform selectivity.
   Hahmann C, Schroeter T. · · 2010 · cited 119× · PMID 19907920 · DOI 10.1007/s00018-009-0189-x
6. Rho Inhibitor VX-210 in Acute Traumatic Subaxial Cervical Spinal Cord Injury: Design of the SPinal Cord Injury Rho INhibition InvestiGation (SPRING) Clinical Trial.
   Fehlings MG, Kim KD, Aarabi B, Rizzo M, et al · · 2018 · cited 75× · PMID 29316845 · DOI 10.1089/neu.2017.5434
7. ROCKing Regeneration: Rho Kinase Inhibition as Molecular Target for Neurorestoration.
   Tönges L, Koch JC, Bähr M, Lingor P. · · 2011 · cited 75× · PMID 22065949 · DOI 10.3389/fnmol.2011.00039
8. Advances in the Signaling Pathways Downstream of Glial-Scar Axon Growth Inhibitors.
   Sami A, Selzer ME, Li S. · · 2020 · cited 63× · PMID 32714150 · DOI 10.3389/fncel.2020.00174