Phase 3
N=352
SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study)
Lumbar Disc Herniation
Bottom Line
View on ClinicalTrials.gov: NCT03607838 ↗Enrolled (actual)
352
Serious AEs
3.8%
Results posted
Jul 2025
Primary outcome: Primary: Change From Baseline to Week 13 in Average Worst Leg Pain Score During the Past 24 Hours Over the Previous 7 Days — -41.7; -34.2 units on a scale — p=0.0263
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SI-6603 (Drug); Sham injection (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Seikagaku Corporation
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 13 in Average Worst Leg Pain Score During the Past 24 Hours Over the Previous 7 Days |
-41.7; -34.2 | 0.0263 sig |
| SECONDARY Change From Baseline to Week 52 in Average Worst Leg Pain Score During the Past 24 Hours Over the Previous 7 Days |
-51.2; -44.7 | 0.0558 |
| SECONDARY Change From Baseline to Week 13 in Herniation Volume |
-103.8; -78.1 | 0.0920 |
| SECONDARY Change From Baseline to Week 13 in Oswestry Disability Index (ODI) Score |
-29.6; -25.4 | 0.0336 sig |
Summary
This study is to evaluate the effectiveness of a single-dose intervertebral disc injection of SI-6603 in subjects with lumbar disc herniation (LDH)
Eligibility Criteria
Inclusion Criteria
- Subjects with single-level LDH (L4-L5 or L5-S1 (or L5-L6)) with clear, demonstrable nerve root impingement as assessed by magnetic resonance imaging (MRI) and clinical symptoms corresponding to position of the impaired nerve root.
- Subjects with radiculopathy/radicular leg pain in the unilateral leg for 6 weeks or more but 1 year or less.
- Subjects with positive result of Straight Leg Raise (SLR) test (≤70°) only on the ipsilateral leg having chief complaint of radiculopathy
- Subjects with inadequate improvement in pain caused by LDH despite 6 weeks or more of conservative treatment.
Exclusion Criteria
- Subjects who have 2 or more lumbar disc herniations as assessed by MRI.
- Subjects who have undergone a lumbar operation, lumbar percutaneous nucleotomy, or lumbar intradiscal therapies at the affected level of lumbar spine.
- Subjects who have received block procedure (e.g., spinal injection, epidural injection or nerve block) for treatment of LDH, oral or injectable corticosteroids within 28 days prior to randomization.
- Subjects who have received opioids or cannabis by any route of administration, local anesthesia to the back, buttock, or posterior/lateral aspects of the affected leg within 7 days prior to randomization.
- Subjects with a body mass index (BMI) ≥40.
- Subjects who are receiving compensation according to the Workers' Compensation Act or are involved in personal injury litigation due to a lumbar-related injury.
Data sourced from ClinicalTrials.gov (NCT03607838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.