Tibial Meniscus InjuriesPhase 2SLAMNCT04331002
Success of Long-acting Anti-inflammatories After Anterior Cruciate Ligament and Meniscal Injury
A Phase 2 study testing Zilretta in people with Tibial Meniscus Injuries and Tibial Meniscus Tears, run by Austin V Stone at 1 site in United States.
Trial summary
The purpose of this study is to determine if extended-release triamcinolone acetonide treatment alters the progressive changes in bone shape previously demonstrated after anterior cruciate ligament (ACL) reconstruction with partial meniscectomy or meniscal repair. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Tibial Meniscus Injuries, Tibial Meniscus Tears, Tibial Meniscus, Torn
- What is being tested?
- Zilretta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2020to 11 Jul 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Written consent to participate in the study
- Male or female greater than or equal to 18 years of age and less than 40 years of age
- Has been consented to undergo arthroscopic ACL reconstruction with partial meniscectomy or meniscal repair
- Ambulatory and in good general health
- Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions.
- Willing to abstain from use of protocol-restricted medications during the study
- Females and males who have reproductive potential: Must use highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation (10 weeks; 4 to 14 weeks after surgery)
- Demonstrate persistent inflammation defined as synovial fluid IL-1a concentration greater than or equal to 5 pg/mL at the time of surgery
Who cannot join
- Known allergic reactions to components of the extended-release triamcinolone acetonide (Zilretta®)
- Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
- History of infection in either knee joint
- Clinical signs and symptoms of active knee infection or crystal disease in either knee within 1 month of Screening
- Other surgery or arthroscopy of either knee within 6 months of Screening
- Intraarticular treatment of any joint with any of the following agents within six (6) months of Screening: any corticosteroid preparation or any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection; investigational or marketed).
Show all 12Show fewer
- Intraarticular treatment in either knee with hyaluronic acid (investigational or marketed) within 6 months of Screening
- Parenteral or oral corticosteroids (investigational or marketed) within 3 months of Screening
- Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening
- Females who are pregnant or nursing or plan to become pregnant during the study; men whose female partner plans to conceive during the study
- Radiographic osteoarthritic changes defined as Kellgren-Lawrence grade 2 or greater (as determined by PI from patient's preoperative X-rays)
- Inability to read and understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
UK Healthcare at Turfland
Lexington, Kentucky, 40504
About this study
The purpose of this study is to determine if extended-release triamcinolone acetonide treatment alters the progressive changes in bone shape previously demonstrated after anterior cruciate ligament (ACL) reconstruction with partial meniscectomy or meniscal repair.
Read the detailed description
Anterior cruciate ligament (ACL) injury initiates a biochemical cascade that leads to cartilage degradation and the development of posttraumatic osteoarthritis (PTOA). ACL and acute traumatic meniscus tears have been linked to the development and progression of PTOA. As such, there is an unmet need to identify treatments that may alter the progression of PTOA following ACL meniscus injury. The overarching hypothesis of this project is that intraarticular administration of long-acting anti-inflammatory agents will alter the progression of PTOA following ACL reconstruction.
The current standard of care for patients with combined ACL and meniscus injuries consists of surgical treatment often with a short course of postoperative physical therapy. However, the current mechanically-based standard of care does not address the persistent inflammatory process that promotes cartilage degradation and PTOA progression. The pro-inflammatory stimulation of meniscus cells increases matrix metalloproteinase (MMP) and cytokine activity, and the combination of pro-inflammatory cytokines and compressive loading like what may be seen during sporting and high demand activities further results in degradative enzyme activity and increased production of pro-inflammatory mediators. In this way, the meniscus plays an active role in promoting the cycle of articular cartilage degradation and PTOA progression after ACL reconstruction.
Reducing MMP and cytokine activity after ACL and meniscus injury may alter the progression of PTOA for this at-risk patient population. After ACL injury and reconstruction demonstrate triamcinolone acetonide effectively reduces cartilage degradation, the inflammatory cascade and corresponding cartilage degradation are reinitiated after surgery, hyaluronate treatment 1 week after surgery unsuccessfully mitigates the inflammatory and catabolic processes, and pain and persistent postsurgical cytokine activity at 4 weeks were predictive of inferior knee biomechanics 6 months after surgery. In addition, long-acting agents may provide a greater treatment effect as temporal regulation of cytokine activity may more successfully alter the pro-inflammatory environment than shorter-duration treatments. These results identify that long-acting anti-inflammatory treatment is needed to alter the path of PTOA following meniscus injury and administration 8 weeks after surgery may offer the optimal timing of treatment.
The model whereby femoral shape change and cytokine activity are mediated by a long-acting anti-inflammatory agent (extended-release triamcinolone acetonide) will be tested. Femoral shape changes have been demonstrated after ACL injury and reconstruction, with shape changes in the first 6 months after surgery correlating with subsequent MRI evidence of cartilage degradation and inferior patient-reported outcomes 3 years postoperatively. A Phase 2a, double-blind, placebo-controlled, randomized controlled trial will be performed. The trial will determine if a long-acting anti-inflammatory agent (extended-release triamcinolone acetonide) improves patient-reported outcomes and/or lessens progressive bone shape changes or cartilage breakdown when compared to placebo (saline). Saline was chosen as the placebo as saline has few potential risks and rare adverse events and is the most commonly used placebo treatment option used in knee osteoarthritis research.
- Conditions
- Tibial Meniscus Injuries, Tibial Meniscus Tears, Tibial Meniscus, Torn, Anterior Cruciate Ligament Tear
- Being tested
- Zilretta, Placebo
- Keywords
- Knee, Meniscectomy, Meniscus Repair, Anti-inflammatory, Anterior cruciate ligament
- Medical subject headings
- Tibial Meniscus Injuries, Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZilrettaDrug
Also called Extended release triamcinolone acetonide
ZILRETTA is an injectable suspension that delivers 32 mg of triamcinolone acetonide. It is supplied as a single-dose kit containing one vial of ZILRETTA microsphere powder, one vial of 5 mL diluent, and one sterile vial adapter.
PlaceboOther
Also called Saline
5 mL normal saline
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The experimental group will receive a single 32 mg Zilretta injection approximately 8 weeks after meniscus surgery. Receives: Drug: Zilretta |
| Placebo | Placebo comparator | The placebo group will receive a single 5 mL injection of normal saline approximately 8 weeks after meniscus surgery. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bone Shape (Baseline to 4 Months)
Using manual segmentation, the volume of the medial femoral condyle will be quantified from 3-Tesla magnetic resonance imaging (MRI) scans performed before and 4 months after the study injection. Medial condyle volume will be expressed as cm3.
Measured: Baseline, 4 months
Secondary outcomes (10)
Change in IKDC (Baseline to 4 Months)
The International Knee Documentation Committee (IKDC) scores range from 0-100 with greater scores being indicative of greater self-reported function and reduced pain.
Measured: Baseline, 4 months, 1 year, 2 years
Change in IKDC (Baseline to 1 Year)
The International Knee Documentation Committee (IKDC) scores range from 0-100 with greater scores being indicative of greater self-reported function and reduced pain.
Measured: Baseline, 4 months, 1 year, 2 years
Change in IKDC (Baseline to 2 Years)
The International Knee Documentation Committee (IKDC) scores range from 0-100 with greater scores being indicative of greater self-reported function and reduced pain.
Measured: Baseline, 4 months, 1 year, 2 years
Change in KOOS Global (Baseline to 4 Months)
The Knee injury and Osteoarthritis Outcome Score (KOOS) Global scores range from 0-100 with greater scores being indicative of greater self-reported knee function and reduced pain and symptoms.
Measured: Baseline, 4 months, 1 year, 2 years
Change in KOOSglobal (Baseline to 1 Year)
The Knee injury and Osteoarthritis Outcome Score (KOOS) Global scores range from 0-100 with greater scores being indicative of greater self-reported knee function and reduced pain and symptoms.
Measured: Baseline, 4 months, 1 year, 2 years
Change in KOOSglobal (Baseline to 2 Years)
The Knee injury and Osteoarthritis Outcome Score (KOOS) Global scores range from 0-100 with greater scores being indicative of greater self-reported knee function and reduced pain and symptoms.
Measured: Baseline, 4 months, 1 year, 2 years
Change in ICOAP (Baseline to 4 Months)
The Intermittent and Constant Osteoarthritis Pain (ICOAP) Score is a valid and reliable tool to assess osteoarthritis-related pain. Scores range from 0 to 100, with greater scores indicating worse pain.
Measured: Baseline, 4 months, 1 year, 2 years
Change in ICOAP (Baseline to 1 Year)
The Intermittent and Constant Osteoarthritis Pain (ICOAP) Score is a valid and reliable tool to assess osteoarthritis-related pain. Scores range from 0 to 100, with greater scores indicating worse pain.
Measured: Baseline, 4 months, 1 year, 2 years
Change in ICOAP (Baseline to 2 Years)
The Intermittent and Constant Osteoarthritis Pain (ICOAP) Score is a valid and reliable tool to assess osteoarthritis-related pain. Scores range from 0 to 100, with greater scores indicating worse pain.
Measured: Baseline, 4 months, 1 year, 2 years
Change in CTXII (Baseline to 4 Months)
C-terminal cross-linked telopeptides (CTX); CTXII levels measured by ELISA. CTXII is a biomarker of type II collagen breakdown
Measured: Baseline, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start21 Aug 2020
- Primary completion11 Jul 2022
- Study completion11 Jul 2022
Why it stopped: Funding Termination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tibial Meniscus InjuriesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After providing informed consent prior to ACL reconstruction with meniscal involvement, synovial fluid will be collected and assessed for the concentration of pro-inflammatory cytokine interleukin-1alpha (IL-1a). This will be done to identify patients that present with persistent inflammation after surgery that may be at increased risk of cartilage degradation. Patients with elevated IL-1a, defined as concentrations \> 5 pg/mL, will then be randomized to one of two groups. The threshold of 5 pg/mL was based on our pilot study of 19 patients. For those with elevated IL-1a, eight weeks after surgery the knee will be aspirated and one group will receive a single 32 mg Zilretta injection and the other group will receive a 5 mL saline injection.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austin V Stone
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Austin V Stone, University of Kentucky
- Investigators
- Austin Stone, MD, PhD, Study director, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331002
- Sponsor's protocol ID
- 53136
- Acronym
- SLAM
- Status last verified
- Jul 2023
- First submitted
- 27 Jul 2019
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: With the participant's approval and as approved by local Institutional Review Boards (IRBs), de-identified biological samples will be stored at the University of Kentucky Orthopedic Biomarker Repository. These samples could be used to research the causes of osteoarthritis after meniscus injury, its complications and other conditions for which individuals with meniscus injuries are at increased risk, and to improve treatment. Before sharing biomarker samples, we will ensure that the participant has given previous consent to the sharing of the information or samples. When we confirm that the previously provided consent is still in effect we will remove identifiers such as (e.g., name, medical record number, or date of birth). We will use a secure electronic log to track information shared without releasing the individual participant's identity.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Success of Long-acting Anti-inflammatories After Anterior Cruciate Ligament and Meniscal Injury
- ClinicalTrials.gov ID
- NCT04331002
- Acronym / sponsor ID
- SLAM / 53136
- Conditions
- Tibial Meniscus Injuries, Tibial Meniscus Tears, Tibial Meniscus, Torn, Anterior Cruciate Ligament Tear
- Keywords
- Knee, Meniscectomy, Meniscus Repair, Anti-inflammatory, Anterior cruciate ligament
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding Termination
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Austin V StoneUniversity, hospital or other
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 11 Jul 2022 (actual)
- Study completion
- 11 Jul 2022 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Posted 27 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if extended-release triamcinolone acetonide treatment alters the progressive changes in bone shape previously demonstrated after anterior cruciate ligament (ACL) reconstruction with partial meniscectomy or meniscal repair.
Detailed description
Anterior cruciate ligament (ACL) injury initiates a biochemical cascade that leads to cartilage degradation and the development of posttraumatic osteoarthritis (PTOA). ACL and acute traumatic meniscus tears have been linked to the development and progression of PTOA. As such, there is an unmet need to identify treatments that may alter the progression of PTOA following ACL meniscus injury. The overarching hypothesis of this project is that intraarticular administration of long-acting anti-inflammatory agents will alter the progression of PTOA following ACL reconstruction.
The current standard of care for patients with combined ACL and meniscus injuries consists of surgical treatment often with a short course of postoperative physical therapy. However, the current mechanically-based standard of care does not address the persistent inflammatory process that promotes cartilage degradation and PTOA progression. The pro-inflammatory stimulation of meniscus cells increases matrix metalloproteinase (MMP) and cytokine activity, and the combination of pro-inflammatory cytokines and compressive loading like what may be seen during sporting and high demand activities further results in degradative enzyme activity and increased production of pro-inflammatory mediators. In this way, the meniscus plays an active role in promoting the cycle of articular cartilage degradation and PTOA progression after ACL reconstruction.
Reducing MMP and cytokine activity after ACL and meniscus injury may alter the progression of PTOA for this at-risk patient population. After ACL injury and reconstruction demonstrate triamcinolone acetonide effectively reduces cartilage degradation, the inflammatory cascade and corresponding cartilage degradation are reinitiated after surgery, hyaluronate treatment 1 week after surgery unsuccessfully mitigates the inflammatory and catabolic processes, and pain and persistent postsurgical cytokine activity at 4 weeks were predictive of inferior knee biomechanics 6 months after surgery. In addition, long-acting agents may provide a greater treatment effect as temporal regulation of cytokine activity may more successfully alter the pro-inflammatory environment than shorter-duration treatments. These results identify that long-acting anti-inflammatory treatment is needed to alter the path of PTOA following meniscus injury and administration 8 weeks after surgery may offer the optimal timing of treatment.
The model whereby femoral shape change and cytokine activity are mediated by a long-acting anti-inflammatory agent (extended-release triamcinolone acetonide) will be tested. Femoral shape changes have been demonstrated after ACL injury and reconstruction, with shape changes in the first 6 months after surgery correlating with subsequent MRI evidence of cartilage degradation and inferior patient-reported outcomes 3 years postoperatively. A Phase 2a, double-blind, placebo-controlled, randomized controlled trial will be performed. The trial will determine if a long-acting anti-inflammatory agent (extended-release triamcinolone acetonide) improves patient-reported outcomes and/or lessens progressive bone shape changes or cartilage breakdown when compared to placebo (saline). Saline was chosen as the placebo as saline has few potential risks and rare adverse events and is the most commonly used placebo treatment option used in knee osteoarthritis research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- After providing informed consent prior to ACL reconstruction with meniscal involvement, synovial fluid will be collected and assessed for the concentration of pro-inflammatory cytokine interleukin-1alpha (IL-1a). This will be done to identify patients that present with persistent inflammation after surgery that may be at increased risk of cartilage degradation. Patients with elevated IL-1a, defined as concentrations > 5 pg/mL, will then be randomized to one of two groups. The threshold of 5 pg/mL was based on our pilot study of 19 patients. For those with elevated IL-1a, eight weeks after surgery the knee will be aspirated and one group will receive a single 32 mg Zilretta injection and the other group will receive a 5 mL saline injection.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: ZilrettaThe experimental group will receive a single 32 mg Zilretta injection approximately 8 weeks after meniscus surgery. |
| Placebo | Placebo comparator | Other: PlaceboThe placebo group will receive a single 5 mL injection of normal saline approximately 8 weeks after meniscus surgery. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Written consent to participate in the study
- Male or female greater than or equal to 18 years of age and less than 40 years of age
- Has been consented to undergo arthroscopic ACL reconstruction with partial meniscectomy or meniscal repair
- Ambulatory and in good general health
- Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions.
Key exclusion criteria (12 listed)
- Known allergic reactions to components of the extended-release triamcinolone acetonide (Zilretta®)
- Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
- History of infection in either knee joint
- Clinical signs and symptoms of active knee infection or crystal disease in either knee within 1 month of Screening
- Other surgery or arthroscopy of either knee within 6 months of Screening
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 |
|---|---|---|
| ZilrettaAlso: Extended release triamcinolone acetonideZILRETTA is an injectable suspension that delivers 32 mg of triamcinolone acetonide. It is supplied as a single-dose kit containing one vial of ZILRETTA microsphere powder, one vial of 5 mL diluent, and one sterile vial adapter. | Drug | Experimental |
| PlaceboAlso: Saline5 mL normal saline | Other | Placebo |
Primary outcome
Change in Bone Shape (Baseline to 4 Months)
Time frame: Baseline, 4 months
Using manual segmentation, the volume of the medial femoral condyle will be quantified from 3-Tesla magnetic resonance imaging (MRI) scans performed before and 4 months after the study injection. Medial condyle volume will be expressed as cm3.
10 secondary outcomes
Change in IKDC (Baseline to 4 Months)
Time frame: Baseline, 4 months, 1 year, 2 years
Change in IKDC (Baseline to 1 Year)
Time frame: Baseline, 4 months, 1 year, 2 years
Change in IKDC (Baseline to 2 Years)
Time frame: Baseline, 4 months, 1 year, 2 years
Change in KOOS Global (Baseline to 4 Months)
Time frame: Baseline, 4 months, 1 year, 2 years
Change in KOOSglobal (Baseline to 1 Year)
Time frame: Baseline, 4 months, 1 year, 2 years
Change in KOOSglobal (Baseline to 2 Years)
Time frame: Baseline, 4 months, 1 year, 2 years
Change in ICOAP (Baseline to 4 Months)
Time frame: Baseline, 4 months, 1 year, 2 years
Change in ICOAP (Baseline to 1 Year)
Time frame: Baseline, 4 months, 1 year, 2 years
Change in ICOAP (Baseline to 2 Years)
Time frame: Baseline, 4 months, 1 year, 2 years
Change in CTXII (Baseline to 4 Months)
Time frame: Baseline, 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. With the participant's approval and as approved by local Institutional Review Boards (IRBs), de-identified biological samples will be stored at the University of Kentucky Orthopedic Biomarker Repository. These samples could be used to research the causes of osteoarthritis after meniscus injury, its complications and other conditions for which individuals with meniscus injuries are at increased risk, and to improve treatment. Before sharing biomarker samples, we will ensure that the participant has given previous consent to the sharing of the information or samples. When we confirm that the previously provided consent is still in effect we will remove identifiers such as (e.g., name, medical record number, or date of birth). We will use a secure electronic log to track information shared without releasing the individual participant's identity.
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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.
Austin Stone, MD, PhD study director
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zilretta in people with Tibial Meniscus Injuries and Tibial Meniscus Tears, run by Austin V Stone at 1 site in United States.
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 8 inclusion and 12 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Bone Shape (Baseline to 4 Months) (time frame: Baseline, 4 months). 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 27 Jul 2023.