SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study)

Study Overview
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Brief Summary
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This study is to evaluate the effectiveness of a single-dose intervertebral disc injection of SI-6603 in subjects with lumbar disc herniation (LDH)

Official Title
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A Multicenter, Randomized, Double-blind, Sham-controlled, Comparative Study of SI-6603 in Subjects With Lumbar Disc Herniation (Phase 3)

Conditions
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Lumbar Disc Herniation

Intervention / Treatment
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* Drug: SI-6603
* Drug: Sham injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SI-6603<br> | Drug: SI-6603<br>* SI-6603 will be injected into an intervertebral disc.<br>|
| Sham Comparator: Sham injection<br> | Drug: Sham injection<br>* The injection will be performed without needle placement into an intervertebral disc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average worst leg pain score during the past 24 hours over the previous 7 days | Assessed by 100 mm Visual Analog Scale (VAS) | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average worst leg pain score during the past 24 hours over the previous 7 days | Assessed by 100 mm Visual Analog Scale (VAS) | 52 weeks | 
| Herniation volume assessed by MRI |  | 13 weeks | 
| Oswestry Disability Index (ODI) score |  | 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar disc herniation, Radiculopathy, Sciatica, Intradiscal injection, Chemonucleolysis