Lyme ArthritisPhase 3NCT04038346
Symptomatic Management of Lyme Arthritis
A Phase 3 study testing Naproxen and Acetaminophen in people with Lyme Arthritis and Lyme Disease, run by Desiree Neville, MD at 1 site in United States.
Trial summary
Lyme arthritis resolves with appropriate antimicrobial treatment in a majority of patients, but 10-20% of patients develop antibiotic-refractory Lyme arthritis with prolonged arthritis symptoms and treatment courses. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Lyme Arthritis, Lyme Disease, Arthritis
- What is being tested?
- Naproxen and Acetaminophen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 12 May 2025
- Phase
- Phase 3
- 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Arthritis
- Undergoing Lyme disease testing (Lyme test positive)
Who cannot join
- Patients will be secondarily withdrawn from analysis and instructed to stop study medication if their Lyme test is negative.
- Underlying diagnosis of rheumatoid or recurrent arthritis Already on scheduled NSAIDs
- Anything that restricts the prescription of naproxen or acetaminophen:
- Hypersensitivity to naproxen (for example: anaphylactic reactions, serious skin reactions) or any component of the formulation; history of aspirin induced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs, underlying kidney or liver impairment
- Already taking daily NSAIDs (naproxen or ibuprofen) or daily acetaminophen
- Hypersensitivity to acetaminophen or any component of the formulation; severe liver impairment or severe active liver disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
About this study
Lyme arthritis resolves with appropriate antimicrobial treatment in a majority of patients, but 10-20% of patients develop antibiotic-refractory Lyme arthritis with prolonged arthritis symptoms and treatment courses. Excessive up-regulation of the inflammatory process has been shown in patients with antibiotic-refractory Lyme arthritis. The over-expressed pro-inflammatory cell mediators are downstream of NSAID inhibition, which would suggest initial inflammatory inhibition may be beneficial in these patients. While NSAIDs are known to reduce pro-inflammatory cell mediators early in the course of inflammation, research has shown that there are other cytokines that play a role in the healing after inflammation that are also inhibited by NSAIDs, and that NSAID use can delay healing.
It is not known if scheduled NSAID therapy will reduce, increase, or have no effect on the occurrence of refractory Lyme arthritis cases. The hypothesis of the study is that prescribing scheduled NSAIDs at the time of diagnosis of Lyme arthritis can prevent the development of the excessive inflammatory phase and decrease the number of patients with antibiotic-refractory Lyme arthritis, or at least decrease the duration of persistent Lyme arthritis symptoms.
The pilot study design randomizes patients to scheduled NSAIDs, scheduled acetaminophen, or scheduled NSAIDs x 1 week than acetaminophen. Primary outcomes are duration of arthritis symptoms, number of refractory cases, side effects and compliance.
Read the detailed description
Specific Aims:
- Demonstrate feasibility to ensure adequate patient enrollment and symptomatic follow-up of patients with Lyme arthritis.
- Develop pilot data necessary for sample size and power calculations:
The purpose of the research study is to evaluate whether there is symptomatic benefit of schedule NSAID therapy in patients with Lyme arthritis diagnosis.
- Quantification of antibiotic-refractory Lyme arthritis in our population
- Symptomatic outcomes of patients with Lyme arthritis on scheduled NSAIDs versus those not placed on scheduled NSAIDs (duration to resolution and number of patients with resistant arthritis)
- Assess side effects of patients with Lyme arthritis placed on scheduled NSAIDs versus those not placed on scheduled NSAIDs
- Assess changes in resources (follow-up visits, further prescriptions) required for patients taking scheduled NSAIDs versus not taking scheduled NSAIDs
Background:
Lyme disease is the systemic tick-borne disease caused by Borrelia burgdorferi infection, and is endemic to an expanding portion of the United States. Lyme arthritis is a common presentation of Lyme disease. While Lyme arthritis resolves with appropriate antimicrobial treatment in a majority of patients, 10-20% of patients develop antibiotic-refractory Lyme arthritis with prolonged inflammatory arthritis. Research suggests excessive up-regulation of the inflammatory process in patients with prolonged symptoms. The over-expressed pro- inflammatory cell mediators are downstream of NSAID inhibition, which would suggest NSAIDs may be beneficial in these patients. In fact, there is data that NSAIDs and/or disease-modifying anti-rheumatic drugs (DMARDs) may be beneficial in refractory Lyme arthritis cases, once diagnosed as refractory.
The hypothesis of the study is that prescribing scheduled NSAIDs at the time of diagnosis can prevent the development of the excessive inflammatory phase and decrease the number of patients with antibiotic-refractory Lyme arthritis, or at least decrease the duration of persistent Lyme arthritis symptoms. There are no known methods to identify patients who will develop antibiotic-refractory Lyme arthritis. This work is important to delineate optimal timing and duration of NSAIDs given the research that shows the anti- inflammatory effects during healing can potentially delay recovery.
Significance:
While antibiotic-refractory Lyme arthritis has been studied at a microbiologic/cytokine level as well as evaluated in terms of treatment once patients have been deemed antibiotic refractory, to our knowledge there are no published studies evaluating prevention.
With no literature looking at the question of NSAIDs for the prevention of antibiotic- refractory Lyme arthritis, this pilot study is needed to adequately calculate sample size and power calculations for a large-scale multicenter study. There is anecdotal data from the Rheumatology and Infectious Disease departments at the UPMC Children's Hospital of Pittsburgh that early scheduled NSAIDs may decrease refractory cases, but there has been no formal evaluation into this question. Retrospective evaluation is challenging since the medications in question (NSAIDs) are over the counter, and clinicians may recommend scheduled or intermittent NSAID therapy without documentation, and certainly without prescriptions in the medical record. Many patients with refractory Lyme arthritis are placed on NSAIDs, but given the question of delayed healing with inhibition of prostaglandins during the healing phase of inflammation, the question of whether NSAIDs are beneficial in patients to prevent refractory arthritis is worthwhile rather than the current process of variable NSAID prescription.
- Conditions
- Lyme Arthritis, Lyme Disease, Arthritis
- Being tested
- Naproxen, Acetaminophen
- Keywords
- Lyme Arthritis, Lyme, Lyme Disease, Arthritis, NSAID
- Medical subject headings
- Lyme Disease, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaproxenDrug
Also called naprosyn, aleve, anaprox
Patients will be randomized to an NSAID (naproxen)
AcetaminophenDrug
Also called tylenol
Patients will be randomized to acetaminophen
| Study group | Role | What they receive |
|---|---|---|
| NSAID | Experimental | Naproxen at weight based standard dose given bid daily until symptoms resolve Receives: Drug: Naproxen |
| Acetaminophen | Active comparator | Acetaminophen at weight based standard dose given qid until symptoms resolve Receives: Drug: Acetaminophen |
| NSAID first, then Acetaminophen | Experimental | Naproxen at weight based standard dose given bid for one week, then acetaminophen at weight based standard dose given qid until symptoms resolve Receives: Drug: Naproxen; Drug: Acetaminophen |
| Standard Care | No intervention | Symptom observation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys
0-100 scale (no pain to worst pain - higher score, worse outcome), slide bar in text survey
Measured: days 0(enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected
Joint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text Surveys
0-100 scale (no redness to maximal redness- higher score, worse outcome), slide bar in text survey
Measured: days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score for join redness will be collected
Joint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text Surveys
0-100 scale (no joint movement to normal joint movement- higher score, better outcome), slide bar in text survey
Measured: days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score for joint movement will be collected
Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys
0-100 scale (severely impaired function to normal function- higher score, better outcome), slide bar in text survey
Measured: days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected
Time to Complete Symptom Resolution as Collected by a Yes/no Question on the Text Survey
If patient answers yes to symptoms completely resolved, the time frame from enrollment will be the days to symptom resolution
Measured: Symptom resolution recorded (days 0, 1, 3, 7, 10, 14, 21, 28, 60) once they enter "yes" to symptoms completely resolved
Secondary outcomes (4)
Medication Compliance as Determined by Question in Serial Text Survey
Parents enter number of days patient has taken the medication in the past day as well as per day since the last survey in two questions on the text survey with their response being a drop down number list on the text survey- medication compliance will be compared to the number of doses that would be full compliance for that treatment arm
Measured: days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)
The Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text Survey
survey asks parents to describe any medication side effects they feel their child has had - descriptive outcome only
Measured: days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)
The Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text Survey
Parents are asked to list any medications in addition to their study drug and the prescribed antibiotic that their child has taken- descriptive outcome only
Measured: days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)
Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey
Parents are asked if their child had fever in the 24 hours prior to taking the text survey
Measured: days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start1 Oct 2019
- Primary completion12 May 2025
- Study completion12 May 2025
Why it stopped: Study with overlapping patient population
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 Lyme ArthritisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, controlled, non blinded
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Desiree Neville, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Desiree Neville, MD, University of Pittsburgh
- Investigators
- Desiree NW Neville, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038346
- Sponsor's protocol ID
- STUDY20040185
- Status last verified
- Nov 2025
- First submitted
- 15 Jul 2019
- Last updated
- 17 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptomatic Management of Lyme Arthritis
- ClinicalTrials.gov ID
- NCT04038346
- Acronym / sponsor ID
- STUDY20040185
- Conditions
- Lyme Arthritis, Lyme Disease, Arthritis
- Keywords
- Lyme Arthritis, Lyme, Lyme Disease, Arthritis, NSAID
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study with overlapping patient population
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Desiree Neville, MDUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 12 May 2025 (actual)
- First posted
- 30 Jul 2019 (actual)
- Results
- Posted 17 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lyme arthritis resolves with appropriate antimicrobial treatment in a majority of patients, but 10-20% of patients develop antibiotic-refractory Lyme arthritis with prolonged arthritis symptoms and treatment courses. Excessive up-regulation of the inflammatory process has been shown in patients with antibiotic-refractory Lyme arthritis. The over-expressed pro-inflammatory cell mediators are downstream of NSAID inhibition, which would suggest initial inflammatory inhibition may be beneficial in these patients. While NSAIDs are known to reduce pro-inflammatory cell mediators early in the course of inflammation, research has shown that there are other cytokines that play a role in the healing after inflammation that are also inhibited by NSAIDs, and that NSAID use can delay healing.
It is not known if scheduled NSAID therapy will reduce, increase, or have no effect on the occurrence of refractory Lyme arthritis cases. The hypothesis of the study is that prescribing scheduled NSAIDs at the time of diagnosis of Lyme arthritis can prevent the development of the excessive inflammatory phase and decrease the number of patients with antibiotic-refractory Lyme arthritis, or at least decrease the duration of persistent Lyme arthritis symptoms.
The pilot study design randomizes patients to scheduled NSAIDs, scheduled acetaminophen, or scheduled NSAIDs x 1 week than acetaminophen. Primary outcomes are duration of arthritis symptoms, number of refractory cases, side effects and compliance.
Detailed description
Specific Aims:
- Demonstrate feasibility to ensure adequate patient enrollment and symptomatic follow-up of patients with Lyme arthritis.
- Develop pilot data necessary for sample size and power calculations:
The purpose of the research study is to evaluate whether there is symptomatic benefit of schedule NSAID therapy in patients with Lyme arthritis diagnosis.
- Quantification of antibiotic-refractory Lyme arthritis in our population
- Symptomatic outcomes of patients with Lyme arthritis on scheduled NSAIDs versus those not placed on scheduled NSAIDs (duration to resolution and number of patients with resistant arthritis)
- Assess side effects of patients with Lyme arthritis placed on scheduled NSAIDs versus those not placed on scheduled NSAIDs
- Assess changes in resources (follow-up visits, further prescriptions) required for patients taking scheduled NSAIDs versus not taking scheduled NSAIDs
Background:
Lyme disease is the systemic tick-borne disease caused by Borrelia burgdorferi infection, and is endemic to an expanding portion of the United States. Lyme arthritis is a common presentation of Lyme disease. While Lyme arthritis resolves with appropriate antimicrobial treatment in a majority of patients, 10-20% of patients develop antibiotic-refractory Lyme arthritis with prolonged inflammatory arthritis. Research suggests excessive up-regulation of the inflammatory process in patients with prolonged symptoms. The over-expressed pro- inflammatory cell mediators are downstream of NSAID inhibition, which would suggest NSAIDs may be beneficial in these patients. In fact, there is data that NSAIDs and/or disease-modifying anti-rheumatic drugs (DMARDs) may be beneficial in refractory Lyme arthritis cases, once diagnosed as refractory.
The hypothesis of the study is that prescribing scheduled NSAIDs at the time of diagnosis can prevent the development of the excessive inflammatory phase and decrease the number of patients with antibiotic-refractory Lyme arthritis, or at least decrease the duration of persistent Lyme arthritis symptoms. There are no known methods to identify patients who will develop antibiotic-refractory Lyme arthritis. This work is important to delineate optimal timing and duration of NSAIDs given the research that shows the anti- inflammatory effects during healing can potentially delay recovery.
Significance:
While antibiotic-refractory Lyme arthritis has been studied at a microbiologic/cytokine level as well as evaluated in terms of treatment once patients have been deemed antibiotic refractory, to our knowledge there are no published studies evaluating prevention.
With no literature looking at the question of NSAIDs for the prevention of antibiotic- refractory Lyme arthritis, this pilot study is needed to adequately calculate sample size and power calculations for a large-scale multicenter study. There is anecdotal data from the Rheumatology and Infectious Disease departments at the UPMC Children's Hospital of Pittsburgh that early scheduled NSAIDs may decrease refractory cases, but there has been no formal evaluation into this question. Retrospective evaluation is challenging since the medications in question (NSAIDs) are over the counter, and clinicians may recommend scheduled or intermittent NSAID therapy without documentation, and certainly without prescriptions in the medical record. Many patients with refractory Lyme arthritis are placed on NSAIDs, but given the question of delayed healing with inhibition of prostaglandins during the healing phase of inflammation, the question of whether NSAIDs are beneficial in patients to prevent refractory arthritis is worthwhile rather than the current process of variable NSAID prescription.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Prospective, randomized, controlled, non blinded
| Arm | Type | Receives |
|---|---|---|
| NSAID | Experimental | Drug: NaproxenNaproxen at weight based standard dose given bid daily until symptoms resolve |
| Acetaminophen | Active comparator | Drug: AcetaminophenAcetaminophen at weight based standard dose given qid until symptoms resolve |
| NSAID first, then Acetaminophen | Experimental | Drug: Naproxen, Drug: AcetaminophenNaproxen at weight based standard dose given bid for one week, then acetaminophen at weight based standard dose given qid until symptoms resolve |
| Standard Care | No intervention | –Symptom observation only |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Arthritis
- Undergoing Lyme disease testing (Lyme test positive)
Key exclusion criteria (6 listed)
- Patients will be secondarily withdrawn from analysis and instructed to stop study medication if their Lyme test is negative.
- Underlying diagnosis of rheumatoid or recurrent arthritis Already on scheduled NSAIDs
- Hypersensitivity to naproxen (for example: anaphylactic reactions, serious skin reactions) or any component of the formulation; history of aspirin induced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs, underlying kidney or liver impairment
- Already taking daily NSAIDs (naproxen or ibuprofen) or daily acetaminophen
- Hypersensitivity to acetaminophen or any component of the formulation; severe liver impairment or severe active liver disease
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 |
|---|---|---|
| NaproxenAlso: naprosyn, aleve, anaproxPatients will be randomized to an NSAID (naproxen) | Drug | NSAID, NSAID first, then Acetaminophen |
| AcetaminophenAlso: tylenolPatients will be randomized to acetaminophen | Drug | Acetaminophen, NSAID first, then Acetaminophen |
Primary outcome
Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys
Time frame: days 0(enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected
0-100 scale (no pain to worst pain - higher score, worse outcome), slide bar in text survey
Joint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text Surveys
Time frame: days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score for join redness will be collected
0-100 scale (no redness to maximal redness- higher score, worse outcome), slide bar in text survey
Joint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text Surveys
Time frame: days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score for joint movement will be collected
0-100 scale (no joint movement to normal joint movement- higher score, better outcome), slide bar in text survey
Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys
Time frame: days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected
0-100 scale (severely impaired function to normal function- higher score, better outcome), slide bar in text survey
Time to Complete Symptom Resolution as Collected by a Yes/no Question on the Text Survey
Time frame: Symptom resolution recorded (days 0, 1, 3, 7, 10, 14, 21, 28, 60) once they enter "yes" to symptoms completely resolved
If patient answers yes to symptoms completely resolved, the time frame from enrollment will be the days to symptom resolution
4 secondary outcomes
Medication Compliance as Determined by Question in Serial Text Survey
Time frame: days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)
The Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text Survey
Time frame: days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)
The Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text Survey
Time frame: days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)
Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey
Time frame: days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Desiree NW Neville, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Naproxen and Acetaminophen in people with Lyme Arthritis and Lyme Disease, run by Desiree Neville, MD 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 2 inclusion and 6 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 17 Nov 2025. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 17 Nov 2025). 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?
Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys (time frame: days 0(enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected). The study lists 5 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 17 Nov 2025.