First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS)

Phase 1TerminatedNCT04483297

Asahi Kasei Pharma Corporation30 enrolled

Overview

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.

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)).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Degenerative Spondylolisthesis Spinal Stenosis

Interventions

AK1320 MSDRUG

AK1320 MS + Local Autologous Bone + Posterior Fixation. Ascending Dose.

ControlOTHER

Local Autologous Bone + Posterior Fixation

Eligibility

Sex: ALLMin age: 22 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (7)

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

London Health Sciences Centre

London, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events

Time frame: 24 months

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.

Time frame: 24 months

Secondary Outcomes

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.

Time frame: 24 months

Oswestry Low Back Pain Disability Questionnaire (ODI)

Time frame: 24 months

36-Item Short Form Survey (SF-36v2®)

Time frame: 24 months

AK1320 plasma concentrations

Time frame: Pre-op(day 0), Post-op (day 0, day1), 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks

Data from ClinicalTrials.gov

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