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

Primary Purpose

Degenerative Spondylolisthesis, Spinal Stenosis

Status
Active
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
AK1320 MS
Control
Sponsored by
Asahi Kasei Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Spondylolisthesis focused on measuring degenerative spondylolisthesis, spinal stenosis, posterolateral lumber fusion surgery, autograft

Eligibility Criteria

22 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal Alexandra Hospital
  • Queen Elizabeth II Health Sciences Centre
  • London Health Sciences Centre
  • Sunnybrook Health Sciences Centre
  • Montreal General Hospital
  • Hôpital Sacré-Coeur de Montréal
  • Centre Hospitalier Universitaire de Québec Laval

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

AK1320 MS

Control

Arm Description

AK1320 MS + Local Autologous Bone + Posterior Fixation

Local Autologous Bone + Posterior Fixation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Oswestry Low Back Pain Disability Questionnaire (ODI)
36-Item Short Form Survey (SF-36v2®)
AK1320 plasma concentrations

Full Information

First Posted
July 14, 2020
Last Updated
January 31, 2023
Sponsor
Asahi Kasei Pharma Corporation
Collaborators
Emergent Clinical Consulting, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04483297
Brief Title
First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS)
Acronym
ENHANCE
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 18, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asahi Kasei Pharma Corporation
Collaborators
Emergent Clinical Consulting, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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, the AK1320 MS group (n=7) and the Control group (n=3).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Spondylolisthesis, Spinal Stenosis
Keywords
degenerative spondylolisthesis, spinal stenosis, posterolateral lumber fusion surgery, autograft

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AK1320 MS
Arm Type
Experimental
Arm Description
AK1320 MS + Local Autologous Bone + Posterior Fixation
Arm Title
Control
Arm Type
Other
Arm Description
Local Autologous Bone + Posterior Fixation
Intervention Type
Drug
Intervention Name(s)
AK1320 MS
Intervention Description
AK1320 MS + Local Autologous Bone + Posterior Fixation. Ascending Dose.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Local Autologous Bone + Posterior Fixation
Primary Outcome Measure Information:
Title
Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events
Time Frame
24 months
Title
Summary of Neurological Status
Description
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 Outcome Measure Information:
Title
Successful Fusion
Description
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
Title
Oswestry Low Back Pain Disability Questionnaire (ODI)
Time Frame
24 months
Title
36-Item Short Form Survey (SF-36v2®)
Time Frame
24 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Facility Information:
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5W9
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Hôpital Sacré-Coeur de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Québec Laval
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1J1Z4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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