A phase 3, randomized, double-blind, sham-controlled trial of SI-6603 (condoliase) in patients with radicular leg pain associated with lumbar disc herniation
Condoliase met its primary endpoint of significantly improving radicular leg pain at Week 13 and was generally well tolerated in patients with LDH. Chemonucleolysis with condoliase has the potential to provide a less invasive treatment option than surgery for those unresponsive to conservative treatment strategies.
Authors
- Pragya B Gupta (ORCID: https://orcid.org/0000-0002-2482-7569)
- José Juan Oliva Rivera
- Ferdinand Formoso
- Thomas R. Fuerst (ORCID: https://orcid.org/0000-0002-9766-9995)
- Yukihiro Matsuyama (ORCID: https://orcid.org/0000-0002-6506-3454)
- Steven Gershon
- Kevin Macadaeg
- Evan James Zucker (ORCID: https://orcid.org/0000-0002-0667-6322)
- Jun Watanabe (ORCID: https://orcid.org/0000-0003-4477-4238)
- Kee D. Kim (ORCID: https://orcid.org/0000-0002-0788-0288)
- Kazuhiro Chiba (ORCID: https://orcid.org/0000-0002-4078-5258)
- Anand Patel (ORCID: https://orcid.org/0000-0001-6418-7386)
- Takayuki Seo
- Farshad Ahadian (ORCID: https://orcid.org/0000-0003-3451-0992)
- Hamid Hassanzadeh (ORCID: https://orcid.org/0000-0002-6129-4722)
- A.E. Miller
- Kenneth D. Candido
Institutions
- Clarion University (US)
- Johns Hopkins University (US)
- Johns Hopkins Medicine (US)
- University of California System (US)
- Hamamatsu University School of Medicine (JP)
- University of California San Diego (US)
- Pain Relief Foundation (GB)
- Chicago Anesthesia Pain Specialists (US)
- Pain Management Institute (US)
- Center for Independent Living (US)
- Medical Advanced Pain Specialists (US)
- Coastal Orthopedics (US)
- Johns Hopkins Hospital (US)
- Indiana Spine Group (US)
- Rho (United States) (US)
- International Drug Development (FR)
- Seikagaku Corporation (Japan) (JP)
- National Defense Medical College (JP)
- University of California, Davis (US)
Publication Details
- Journal
- The Spine Journal
- Published
- 2024-08-19
- DOI
- https://doi.org/10.1016/j.spinee.2024.08.006
- Citations
- 11
- Primary Topic
- Spine and Intervertebral Disc Pathology
- Type
- article
- Field-Weighted Citation Impact
- 4.67
Funders
- NuVasive
- Seikagaku Corporation