TerminatedPhase 1

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

Stopped: Sponsor decision

Canada30 participantsStarted 2020-11-18

Plain-language 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.

Who can participate

Age range22 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: 24 months

Summary of Neurological Status

Timeframe: 24 months

Trial details

NCT IDNCT04483297

SponsorAsahi Kasei Therapeutics Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-27

View on ClinicalTrials.gov More Degenerative Spondylolisthesis trials