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AK1320 Microspheres for Spinal Stenosis (ENHANCE Trial)

Phase 1
Waitlist Available
Research Sponsored by Asahi Kasei Pharma Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female over 22 years of age and less than 81 years of age.
Moderate or higher disability as assessed by Oswestry Disability Index.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

ENHANCE Trial Summary

This trial will test a new drug, AK1320 MS, to see if it is safe and effective in treating patients with degenerative spondylolisthesis and concomitant symptomatic spinal stenosis.

Who is the study for?
This trial is for men and women aged 22-80 with degenerative spondylolisthesis (Grade 1 or 2) and spinal stenosis causing moderate to severe disability. Participants must be undergoing specific spine fusion surgery using their own bone. Excluded are those with significant spinal instability, a BMI over 40, scoliosis requiring multi-level fusion, recent back surgeries, or involved in workers' comp claims.Check my eligibility
What is being tested?
The study tests AK1320 MS microspheres in patients having decompression and single-level spine fusion surgery for spondylolisthesis with spinal stenosis. It aims to assess the safety and effectiveness of this treatment compared to a control group not receiving the microspheres.See study design
What are the potential side effects?
While the side effects of AK1320 MS aren't detailed here, typical risks may include inflammation at the injection site, pain, infection risk from surgery, possible allergic reactions to materials used in microspheres, or complications related to spine surgery.

ENHANCE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 22 and 80 years old.
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My back pain significantly limits my daily activities.
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I am using my own bone for the procedure.
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My condition affects my lower spine from L1 to S1.
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My spine condition is classified as mild to moderate.
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I experience leg pain from nerve issues, with or without back pain.

ENHANCE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events
Summary of Neurological Status
Secondary outcome measures
36-Item Short Form Survey (SF-36v2®)
AK1320 plasma concentrations
Oswestry Low Back Pain Disability Questionnaire (ODI)
+1 more

ENHANCE Trial Design

2Treatment groups
Experimental Treatment
Group I: ControlExperimental Treatment1 Intervention
Local Autologous Bone + Posterior Fixation
Group II: AK1320 MSExperimental Treatment1 Intervention
AK1320 MS + Local Autologous Bone + Posterior Fixation

Find a Location

Who is running the clinical trial?

Emergent Clinical Consulting, LLCIndustry Sponsor
3 Previous Clinical Trials
2,569 Total Patients Enrolled
Asahi Kasei Pharma CorporationLead Sponsor
15 Previous Clinical Trials
2,781 Total Patients Enrolled

Media Library

AK1320 MS (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04483297 — Phase 1
Spinal Stenosis Research Study Groups: Control, AK1320 MS
Spinal Stenosis Clinical Trial 2023: AK1320 MS Highlights & Side Effects. Trial Name: NCT04483297 — Phase 1
AK1320 MS (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04483297 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals will be participating in this research endeavor?

"To adequately execute this medical trial, Emergent Clinical Consulting, LLC needs to recruit 40 eligible candidates. To do so they will be conducting the study at Sunnybrook Health Sciences Centre and London Health Sciences Centre in Ontario and Quebec respectively."

Answered by AI

Is this medical experiment recruiting participants who are senior citizens?

"The stated requirements for potential patients of this trial are that they must be between the ages of 22 and 80. There exist 23 studies targeted towards those under 18 years old, whereas 265 trials focus on individuals over 65."

Answered by AI

In what locales has this research been conducted?

"In addition to the Sunnybrook Health Sciences Centre in Toronto, Ontario, and London Health Sciences Centre in London, Quebec; Montreal General Hospital in Montreal, Nova Scotia is also hosting this clinical trial. Furthermore, there are 7 other sites participating."

Answered by AI

Are there opportunities for new participants to enroll in this experiment?

"Affirmative. According to clinicaltrials.gov, this research study is presently recruiting participants for its trials which were first announced on the 18th of November 2020 and have been recently updated as of May 17 2022. Forty individuals are desired from seven distinct medical centres to take part in the experiment."

Answered by AI

What qualifications are necessary for potential participants in this trial?

"Eligibility for this trial necessitates that participants have spinal stenosis and are between 22 to 80 years of age. Approximately 40 patients need to be enrolled in the study."

Answered by AI

Has AK1320 MS been granted clearance by the Food and Drug Administration?

"Due to the scarcity of data on efficacy and safety, AK1320 MS only receives a score of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS)
2020. "First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04483297.
~7 spots leftby Apr 2025
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