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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04483297
Other study ID # AK1320-101
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date November 18, 2020
Est. completion date January 30, 2024

Study information

Verified date March 2024
Source Asahi Kasei Pharma Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 instrumented posterolateral lumber autograft fusion surgery.


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 with each cohort having 2 treatment groups. Cohort 1 and Cohort 2 (AK1320 MS group (n=3-7); Control group (n=0-3)) and Cohort 3 and Cohort 4 (AK1320 MS group (n=6-7); Control group (n=0-3)).


Recruitment information / eligibility

Status Terminated
Enrollment 30
Est. completion date January 30, 2024
Est. primary completion date November 27, 2023
Accepts healthy volunteers No
Gender All
Age group 22 Years to 80 Years
Eligibility Inclusion Criteria: 1. Involved level L1 to S1 2. Use of local autologous bone only. 3. Degenerative spondylolisthesis up to Meyerding's Classification Grade 1 or 2. 4. Moderate or higher disability as assessed by Oswestry Disability Index. 5. Neurogenic claudication and/or radiculopathy with or without back pain. 6. Male or female over 22 years of age and less than 81 years of age. Exclusion Criteria: 1. Prior lumbar decompression or spine fusion attempt (any level). 2. Undergoing concurrent interbody fusion. 3. Requires spinal fusion at more than one lumbar level. 4. Degenerative scoliosis. 5. BMI > 40. 6. Radiographically confirmed significant spinal instability. 7. Active or recent (within the past two (2) years) worker's compensation litigation.

Study Design


Intervention

Drug:
AK1320 MS
AK1320 MS + Local Autologous Bone + Posterior Fixation. Ascending Dose.
Other:
Control
Local Autologous Bone + Posterior Fixation

Locations

Country Name City State
Canada Royal Alexandra Hospital Edmonton Alberta
Canada Queen Elizabeth II Health Sciences Centre Halifax Nova Scotia
Canada London Health Sciences Centre London Ontario
Canada Hôpital Sacré-Coeur de Montréal Montreal Quebec
Canada Montreal General Hospital Montreal Quebec
Canada Centre Hospitalier Universitaire de Québec Laval Québec Quebec
Canada Sunnybrook Health Sciences Centre Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
Asahi Kasei Pharma Corporation Emergent Clinical Consulting, LLC

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events 24 months
Primary Summary of Neurological Status Neurological status will be determined preoperatively and postoperatively using a comprehensive neurological status scale. Neurological status is based on four types of measurements: lower extremity motor, dermatomal sensation, reflexes and straight leg raise. 24 months
Secondary Successful Fusion Fusion will be evaluated through CT scans. Successful fusion will be defined as complete bridging bone between the index level transverse processes with a lack of lucency or lucent lines through the fusion mass. 24 months
Secondary Oswestry Low Back Pain Disability Questionnaire (ODI) 24 months
Secondary 36-Item Short Form Survey (SF-36v2®) 24 months
Secondary AK1320 plasma concentrations Pre-op(day 0), Post-op (day 0, day1), 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks
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