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

NCT04483297 | Terminated Phase 1

• 1 other identifier: AK1320-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

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.

Conditions

Degenerative Spondylolisthesis; Spinal Stenosis

Keywords

degenerative spondylolisthesis; spinal stenosis; posterolateral lumber fusion surgery; autograft

Outcome Measures

Primary Outcomes (2)

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

  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.

  24 months

Secondary Outcomes (4)

• Successful Fusion

  24 months

• Oswestry Low Back Pain Disability Questionnaire (ODI)

  24 months

• 36-Item Short Form Survey (SF-36v2®)

  24 months

• 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

Study Arms (2)

AK1320 MS

EXPERIMENTAL

AK1320 MS + Local Autologous Bone + Posterior Fixation

Drug: AK1320 MS

Control

OTHER

Local Autologous Bone + Posterior Fixation

Other: Control

Interventions

AK1320 MS DRUG

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

AK1320 MS

Control OTHER

Local Autologous Bone + Posterior Fixation

Control

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asahi Kasei Pharma Corporation: lead
• Emergent Clinical Consulting, LLC: collaborator

Study Sites (7)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

London Health Sciences Centre

London, Ontario, N6A5W9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Hôpital Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

Centre Hospitalier Universitaire de Québec Laval

Québec, Quebec, G1J1Z4, Canada

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 23, 2020
• Study Start: November 18, 2020
• Primary Completion: November 27, 2023
• Study Completion: January 30, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)