Status:
TERMINATED
First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS)
Lead Sponsor:
Asahi Kasei Pharma Corporation
Collaborating Sponsors:
Emergent Clinical Consulting, LLC
Conditions:
Degenerative Spondylolisthesis
Spinal Stenosis
Eligibility:
All Genders
22-80 years
Phase:
PHASE1
Brief Summary
The safety and efficacy of AK1320 MS will be evaluated in patients with degenerative spondylolisthesis and concomitant symptomatic spinal stenosis who are undergoing decompression and single level ins...
Detailed Description
This will be a first in human Phase I, ascending dose, multi-center, randomized patient study evaluating the efficacy, safety, PK of AK1320 MS. The study will enroll up to 4 dose escalating cohorts wi...
Eligibility Criteria
Inclusion
- Involved level L1 to S1
- Use of local autologous bone only.
- Degenerative spondylolisthesis up to Meyerding's Classification Grade 1 or 2.
- Moderate or higher disability as assessed by Oswestry Disability Index.
- Neurogenic claudication and/or radiculopathy with or without back pain.
- Male or female over 22 years of age and less than 81 years of age.
Exclusion
- Prior lumbar decompression or spine fusion attempt (any level).
- Undergoing concurrent interbody fusion.
- Requires spinal fusion at more than one lumbar level.
- Degenerative scoliosis.
- BMI \> 40.
- Radiographically confirmed significant spinal instability.
- Active or recent (within the past two (2) years) worker's compensation litigation.
Key Trial Info
Start Date :
November 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04483297
Start Date
November 18 2020
End Date
January 30 2024
Last Update
March 6 2024
Active Locations (7)
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1
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
2
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
3
London Health Sciences Centre
London, Ontario, Canada, N6A5W9
4
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5