Clinical trial NCT04483297: First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS)
Official title: First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS) In Subjects With Degenerative Spondylolisthesis and Concomitant Symptomatic Spinal Stenosis Who Are Undergoing Decompression And Single Level Instrumented Posterolateral Lumbar Autograft Fusion Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Degenerative Spondylolisthesis
Spinal Stenosis
Keywords: degenerative spondylolisthesis
spinal stenosis
posterolateral lumber fusion surgery
autograft
Lead sponsor: Asahi Kasei Pharma Corporation
Sponsor class: INDUSTRY
Collaborators: name: Emergent Clinical Consulting, LLC
First posted: 2020-07-23
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 instrumented posterolateral lumber autograft fusion surgery.

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 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)).

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events
timeFrame: 24 months
measure: Summary of Neurological Status
timeFrame: 24 months
Secondary outcomes:
measure: Successful Fusion
timeFrame: 24 months
measure: Oswestry Low Back Pain Disability Questionnaire (ODI)
timeFrame: 24 months
measure: 36-Item Short Form Survey (SF-36v2®)
timeFrame: 24 months
measure: AK1320 plasma concentrations
timeFrame: Pre-op(day 0), Post-op (day 0, day1), 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Montreal
country: Canada
facility: Hôpital Sacré-Coeur de Montréal
state: Quebec
city: Québec
country: Canada
facility: Centre Hospitalier Universitaire de Québec Laval
state: Quebec
Study officials:
References: