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

Spinal Stenosis Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04483297
• Other study ID #: AK1320-101
• Status: Terminated
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Degenerative Spondylolisthesis
• Spinal Stenosis
• Spondylolisthesis

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