Degenerative SpondylolisthesisPhase 1ENHANCENCT04483297
First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS)
A Phase 1 study testing AK1320 MS in people with Degenerative Spondylolisthesis and Spinal Stenosis, run by Asahi Kasei Therapeutics Corporation at 7 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Degenerative Spondylolisthesis, Spinal Stenosis
- What is being tested?
- AK1320 MS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesCanada
- Study dates
- 18 Nov 2020to 30 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
London Health Sciences Centre
London, Ontario, N6A5W9
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Hôpital Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5
Centre Hospitalier Universitaire de Québec Laval
Québec, Quebec, G1J1Z4
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
About this study
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
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.
Read the 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. 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)).
- Conditions
- Degenerative Spondylolisthesis, Spinal Stenosis
- Being tested
- AK1320 MS, Control
- Keywords
- degenerative spondylolisthesis, spinal stenosis, posterolateral lumber fusion surgery, autograft
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK1320 MSDrug
AK1320 MS + Local Autologous Bone + Posterior Fixation. Ascending Dose.
ControlOther
Local Autologous Bone + Posterior Fixation
| Study group | Role | What they receive |
|---|---|---|
| AK1320 MS | Experimental | AK1320 MS + Local Autologous Bone + Posterior Fixation Receives: Drug: AK1320 MS |
| Control | Other | Local Autologous Bone + Posterior Fixation Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events
Measured: 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.
Measured: 24 months
Secondary outcomes (4)
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.
Measured: 24 months
Oswestry Low Back Pain Disability Questionnaire (ODI)
Measured: 24 months
36-Item Short Form Survey (SF-36v2®)
Measured: 24 months
AK1320 plasma concentrations
Measured: Pre-op(day 0), Post-op (day 0, day1), 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start18 Nov 2020
- Primary completion27 Nov 2023
- Study completion30 Jan 2024
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative SpondylolisthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asahi Kasei Therapeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emergent Clinical Consulting, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483297
- Sponsor's protocol ID
- AK1320-101
- Acronym
- ENHANCE
- Status last verified
- Mar 2024
- First submitted
- 14 Jul 2020
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04483297
- Acronym / sponsor ID
- ENHANCE / AK1320-101
- Conditions
- Degenerative Spondylolisthesis, Spinal Stenosis
- Keywords
- degenerative spondylolisthesis, spinal stenosis, posterolateral lumber fusion surgery, autograft
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Asahi Kasei Therapeutics CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Emergent Clinical Consulting, LLC
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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)).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AK1320 MS | Experimental | Drug: AK1320 MSAK1320 MS + Local Autologous Bone + Posterior Fixation |
| Control | Other | Other: ControlLocal Autologous Bone + Posterior Fixation |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK1320 MSAK1320 MS + Local Autologous Bone + Posterior Fixation. Ascending Dose. | Drug | AK1320 MS |
| ControlLocal Autologous Bone + Posterior Fixation | Other | Control |
Primary outcome
Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events
Time frame: 24 months
Summary of Neurological Status
Time frame: 24 months
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.
4 secondary outcomes
Successful Fusion
Time frame: 24 months
Oswestry Low Back Pain Disability Questionnaire (ODI)
Time frame: 24 months
36-Item Short Form Survey (SF-36v2®)
Time frame: 24 months
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
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AK1320 MS in people with Degenerative Spondylolisthesis and Spinal Stenosis, run by Asahi Kasei Therapeutics Corporation at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.