Multiple Sclerosis, Relapsing-RemittingNCT04972929

Effects of Chiropractic Care on Cytokine Levels in Multiple Sclerosis

A study testing Spinal Manipulation in people with Multiple Sclerosis, Relapsing-Remitting, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Multiple Sclerosis, Relapsing-Remitting
What is being tested?: Spinal Manipulation
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 26 participants
Where: 1 siteUnited States
Study dates: 15 Sep 2023to 12 Mar 2025
Phase: Interventional
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 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Age 18 to 55 years
Physician-confirmed diagnosis of MS within the last 5 years
Expanded Disability Status Scale (EDSS) score below 4 based on Neurostatus-certified examination
Relapse free in the last 30 days
No known cardiovascular, pulmonary, or metabolic disease
Currently on stable FDA-approved disease modifying therapy (eg, interferon beta-1a or beta-1b, natalizumab etc.)

Show all 9Show fewer

Naïve to chiropractic care
No contraindications to spinal manipulation
Acceptance of informed consent.

Who cannot join

Uncontrolled hypertension (systolic pressure >160 mmHg, diastolic blood pressure >95 mmHg) Any past spinal surgery or recent history of bone fractures
Pregnancy in the last 12 months
Unable to understand English or follow simple instruction.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Alabama at Birmingham
Birmingham, Alabama, 35294

Other trials in United States

About this study

Official title: Effects of Chiropractic Care on Pro- and Anti-inflammatory Cytokine Levels in Multiple Sclerosis

Multiple sclerosis (MS) is an inflammatory autoimmune disease associated with an imbalance between pro- and anti-inflammatory markers (cytokines) resulting in a demyelinating and neurodegenerative disease. There is early evidence that spinal manipulation (chiropractic care) is better than control in influencing immune (cytokine) activity in asymptomatic participants, but few studies have been completed in participants with chronic inflammatory conditions, such as MS. The purpose of this project is to examine the immediate (after a single thoracic spinal manipulation treatment) and summative impact (after 8 thoracic spinal manipulation treatments occurring over 4 weeks) on pro-inflammatory (interleukin (IL) IL-1ß, IL-2, IL-6, Tumor necrosis factor-alpha) and anti-inflammatory (IL-4, IL-10) plasma cytokines 20 minutes and 2 hours after thoracic spinal manipulation in participants diagnosed with neuroinflammatory relapsing-remitting MS (RR-MS). Spinal manipulation treatment will be limited to the thoracic spine. Secondary outcomes will include determining the impact of 8 thoracic spinal manipulations on fatigue, cognitive processing speed, pain, depression, sleep, and motor function through questionnaires and performance of various in assessments such as the timed 25 foot walk test.

Read the detailed description

Study Design. The investigators plan to conduct a pilot parallel-group randomized controlled trial with appropriate SM and Sham SM treatment groups. Randomization will occur with the sequence being completed prior to enrolling the first participant and with concealed allocation by a member of the team not involved with the outcomes or treatments. The investigators designed the Sham SM treatments to ensure all participants have similar amounts of physical contact and clinician interaction (i.e. contextual environment for placebo-related improvement). The primary and secondary outcomes of the study will be assessed and processed by blinded assessors who are not part of the intervention delivery to reduce any potential bias in collected outcomes.

SM Delivery. Diversified (i.e. crossed bilateral hypothenar contact) chiropractic technique will be administered at levels of identified spinal joint restriction/dysfunction (derived from thoracic spine x-rays, static and motion palpation, and confirmed or provoked localized tenderness in paraspinal soft tissues). Participants in the SM and Sham SM group will be scheduled for 8 office visits (2x/wk) over a period of 4 weeks.

The Sham-SM will be delivered by setting the expansion control knob on an Activator II (Activator Methods®, Phoenix AZ) device to the zero position (off; no thrust) and placed onto the dorsal thumb surface of the clinician (no actual instrument contact with study participant). At a setting of zero, no excursion of the Activator II stylus occurs, despite the device delivering an audible clicking sound, with no biomechanical force being imparted to the participant.

Primary Outcome Variable. To examine the immediate (1x) and summative impact of SM (8x/4wk) on pro-inflammatory and anti-inflammatory plasma cytokine levels at 20 minutes and 2 hours post-SM (after the first and 8th treatment) and compared to baseline measures.

Secondary Outcome Variables. To examine the summative and secondary impact of 8 chiropractic treatments over 4 weeks on RR-MS-related fatigue (Fatigue Severity Scale, Modified Fatigue Impact Scale), cognitive processing speed (Symbol Digit Modalities Test), pain (short-form McGill Pain Questionnaire), depression (Hospital Anxiety Depression Scale), subjective sleep (Insomnia Severity Index) and upper/lower body motor function (Nine-Hole Peg Test, Timed 25 foot Walk Test). These secondary outcomes will be measured before onset of treatment (baseline) and upon completion of 8 spinal manipulation treatments over the period of 4 weeks) (2 visits per week).

Conditions: Multiple Sclerosis, Relapsing-Remitting
Being tested: Spinal Manipulation, Sham Spinal Manipulation
Keywords: chiropractic, spinal manipulation, multiple sclerosis, cytokines
Medical subject headings: Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Spinal ManipulationOther
Also called chiropractic care
Diversified (i.e. crossed bilateral hypothenar contact) chiropractic technique will be administered at levels of identified spinal joint restriction/dysfunction (derived from thoracic spine x-rays, static and motion palpation, and confirmed or provoked localized tenderness in paraspinal soft tissues).
Sham Spinal ManipulationOther
Sham-SM will be delivered by setting the expansion control knob on an Activator II (Activator Methods®, Phoenix AZ) device to the zero position (off; no thrust) and placed onto the dorsal thumb surface of the clinician (no actual instrument contact with study participant). At a setting of zero, no excursion of the Activator II stylus occurs, despite the device delivering an audible clicking sound, with no biomechanical force being imparted to the participant.

Study groups in NCT04972929
Study group	Role	What they receive
Spinal Manipulation	Experimental	The spinal manipulation (SM) group will receive manually delivered SM limited to the thoracic spine. Receives: Other: Spinal Manipulation
Sham Spinal Manipulation	Sham comparator	Sham-spinal manipulation will be delivered by setting the expansion control knob on an Activator II (Activator Methods®) device to the zero position (off; no thrust) and placed onto the dorsal thumb surface of the clinician. At a setting of zero, no excursion of the Activator II stylus occurs, despite the device delivering an audible clicking sound, with no biomechanical force being imparted. Receives: Other: Sham Spinal Manipulation

What is being measured

The primary outcome is the main question the study is designed to answer.

IL-6 Serum Inflammatory Cytokine Levels
Determined mean changes in serum inflammatory cytokine levels from baseline for each group
Measured: From baseline to after 8th treatment at 4 weeks
IL-4 Serum Inflammatory Cytokine Levels
Determine changes in serum inflammatory cytokine levels from baseline
Measured: From baseline to after 8th treatment at 4 weeks
IL-10 Serum Inflammatory Cytokine Levels
Determine changes in serum inflammatory cytokine levels from baseline
Measured: From baseline to after 8th treatment at 4 weeks
IL-2 Serum Inflammatory Cytokine Levels
Determine changes in serum inflammatory cytokine levels from baseline
Measured: From baseline to after 8th treatment at 4 weeks
TNFalpha Serum Inflammatory Cytokine
Determine changes in serum inflammatory cytokine levels from baseline
Measured: baseline to after 8th treatment at 4 weeks
IL-B Serum Cytokine Levels
Mean change in serum from baseline and after 8 treatments
Measured: baseline and 8th treatment after 4 weeks

Secondary outcomes (8)

Fatigue Severity Scale (FSS)
Determine changes in fatigue from baseline. It is a 9 item scale determining fatigue severity and its effect on a person's activities.
The 9-item Fatigue Severity Scale (FSS) is a self-report questionnaire designed to measure the severity of fatigue and its impact on daily functioning over the past week. Respondents rate nine statements on a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree). The scores for the nine statements are averaged to compute a total score ranging from 1 to 7, with higher average scores indicating greater fatigue severity.
Measured: From Baseline to after 8th treatment at 4 weeks
Modified Fatigue Impact Scale
Determine changes in fatigue and tiredness from baseline. It is a 21 item scale that provides a more in-depth look at the impact of fatigue and lack of energy might have on mental alertness and daily activities. It evaluates three domains: physical, cognitive, and psychosocial functioning, typically over the past 4 weeks, with a total score range of 0-84 (higher number indicate greater fatigue)
Measured: From baseline to after 8th treatment at 4 weeks
Cognitive Processing Speed
Determine changes in cognitive (rapid) processing speed from baseline. Assesses the time it takes to complete a mental task and is related to the speed at which a person can understand and react to a set of information that they receive.
Measured: From Baseline to after 8th treatment at 4 weeks
Total Change in Pain Short-form McGill Pain Questionnaire
The McGill Pain Questionnaire (MPQ) is a multidimensional self-report tool used to evaluate the quality, location, and intensity of a patient's pain. The mean change in pain scores will be totaled on a scale of 0-3, where 3 equals more severe pain on 15 separate items totaled to compute a total minimum score of 0 and maximum score of 45.
Measured: From Baseline to after 8th treatment at 4 weeks
Total Change in Hospital Anxiety Depression Scale
Determine changes in anxiety/depression from baseline. This is a 14 item instrument that you respond to inquires related about you have felt during the last week.The total score is out of 0-42, (0-21 per subscale). Total Scores are derived by summing responses for each of the two subscales or for the scale as a whole. Higher scores indicate greater levels of anxiety or depression.
Measured: From Baseline to after 8th treatment at 4 weeks
Insomnia Severity Index
Determine changes in sleep quality from baseline. This is a 7 item instrument to assess components of nighttime and daytime insomnia. The Insomnia Severity Index (ISI) is a 7-item, self-report questionnaire used to assess the severity of insomnia, with a total score ranging from 0-28. A score of 15 or higher is typically used to indicate moderate-to-severe clinical insomnia, with 8-14 indicating subthreshold insomnia.
Measured: From Baseline to after 8th treatment at 4 weeks
Nine-Hole Peg Test
Determine changes in upper limb coordination from baseline. This is a standardized timed assessment to assess finger dexterity in which 9 wooden pegs are placed into predrilled holes in a block of wood.
Measured: From Baseline to after 8th treatment at 4 weeks
Timed 25 Foot Walk Test
Determine changes in lower limb mobility from baseline. Evaluates leg function and quantitative mobility in a timed 25 foot walk.
Measured: From Baseline to after 8th treatment at 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 202312 Mar 2025

First posted22 Jul 2021
Study start15 Sep 2023
Primary completion12 Mar 2025
Study completion12 Mar 2025

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: e plan to conduct a randomized pilot parallel-group randomized controlled trial (RCT) with appropriate SM and Sham SM treatment groups.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04972929
Sponsor's protocol ID: IRB-300007021
Other IDs: TRG2020
Status last verified: Jul 2026
First submitted: 27 Apr 2021
Last updated: 20 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Alanazi MS, Motl RW, Jones BA, Qu H, Li P, Reed WR. Effects of thoracic manipulation with trigger point therapy on inflammatory cytokine levels in individuals with multiple sclerosis: a pilot study. Front Rehabil Sci. 2026 Apr 8;7:1699274. doi: 10.3389/fresc.2026.1699274. eCollection 2026.
PubMed 42028147

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Chiropractic Care on Pro- and Anti-inflammatory Cytokine Levels in Multiple Sclerosis
ClinicalTrials.gov ID: NCT04972929
Acronym / sponsor ID: IRB-300007021
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: chiropractic, spinal manipulation, multiple sclerosis, cytokines
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Study start: 15 Sep 2023 (actual)
Primary completion: 12 Mar 2025 (actual)
Study completion: 12 Mar 2025 (actual)
First posted: 22 Jul 2021 (actual)
Results: Posted 20 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: e plan to conduct a randomized pilot parallel-group randomized controlled trial (RCT) with appropriate SM and Sham SM treatment groups.

Arm	Type	Receives
Spinal Manipulation	Experimental	Other: Spinal ManipulationThe spinal manipulation (SM) group will receive manually delivered SM limited to the thoracic spine.
Sham Spinal Manipulation	Sham comparator	Other: Sham Spinal ManipulationSham-spinal manipulation will be delivered by setting the expansion control knob on an Activator II (Activator Methods®) device to the zero position (off; no thrust) and placed onto the dorsal thumb surface of the clinician. At a setting of zero, no excursion of the Activator II stylus occurs, despite the device delivering an audible clicking sound, with no biomechanical force being imparted.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Age 18 to 55 years
Physician-confirmed diagnosis of MS within the last 5 years
Expanded Disability Status Scale (EDSS) score below 4 based on Neurostatus-certified examination
Relapse free in the last 30 days
No known cardiovascular, pulmonary, or metabolic disease

Key exclusion criteria (3 listed)

Uncontrolled hypertension (systolic pressure >160 mmHg, diastolic blood pressure >95 mmHg) Any past spinal surgery or recent history of bone fractures
Pregnancy in the last 12 months
Unable to understand English or follow simple instruction.

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
Spinal ManipulationAlso: chiropractic careDiversified (i.e. crossed bilateral hypothenar contact) chiropractic technique will be administered at levels of identified spinal joint restriction/dysfunction (derived from thoracic spine x-rays, static and motion palpation, and confirmed or provoked localized tenderness in paraspinal soft tissues).	Other	Spinal Manipulation
Sham Spinal ManipulationSham-SM will be delivered by setting the expansion control knob on an Activator II (Activator Methods®, Phoenix AZ) device to the zero position (off; no thrust) and placed onto the dorsal thumb surface of the clinician (no actual instrument contact with study participant). At a setting of zero, no excursion of the Activator II stylus occurs, despite the device delivering an audible clicking sound, with no biomechanical force being imparted to the participant.	Other	Sham Spinal Manipulation

Primary outcome

IL-6 Serum Inflammatory Cytokine Levels
Time frame: From baseline to after 8th treatment at 4 weeks
Determined mean changes in serum inflammatory cytokine levels from baseline for each group
IL-4 Serum Inflammatory Cytokine Levels
Time frame: From baseline to after 8th treatment at 4 weeks
Determine changes in serum inflammatory cytokine levels from baseline
IL-10 Serum Inflammatory Cytokine Levels
Time frame: From baseline to after 8th treatment at 4 weeks
Determine changes in serum inflammatory cytokine levels from baseline
IL-2 Serum Inflammatory Cytokine Levels
Time frame: From baseline to after 8th treatment at 4 weeks
Determine changes in serum inflammatory cytokine levels from baseline
TNFalpha Serum Inflammatory Cytokine
Time frame: baseline to after 8th treatment at 4 weeks
Determine changes in serum inflammatory cytokine levels from baseline
IL-B Serum Cytokine Levels
Time frame: baseline and 8th treatment after 4 weeks
Mean change in serum from baseline and after 8 treatments

8 secondary outcomes

Fatigue Severity Scale (FSS)
Time frame: From Baseline to after 8th treatment at 4 weeks
Modified Fatigue Impact Scale
Time frame: From baseline to after 8th treatment at 4 weeks
Cognitive Processing Speed
Time frame: From Baseline to after 8th treatment at 4 weeks
Total Change in Pain Short-form McGill Pain Questionnaire
Time frame: From Baseline to after 8th treatment at 4 weeks
Total Change in Hospital Anxiety Depression Scale
Time frame: From Baseline to after 8th treatment at 4 weeks
Insomnia Severity Index
Time frame: From Baseline to after 8th treatment at 4 weeks
Nine-Hole Peg Test
Time frame: From Baseline to after 8th treatment at 4 weeks
Timed 25 Foot Walk Test
Time frame: From Baseline to after 8th treatment at 4 weeks

Results and safety

Results posted to the registry on 20 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Thoracic Spinal Manipulation/Trigger Point Therapy Group	11	11
Sham-spinal Manipulation Group	10	10

Primary outcome: IL-6 Serum Inflammatory Cytokine Levels

Time frame: From baseline to after 8th treatment at 4 weeks. Mean (Standard Deviation). Unit: pg/mL

Measure	Spinal Manipulation/Trigger Point Therapy n = 11	Sham-spinal Manipulation n = 10
Value	3.85 (6.01)	2.76 (4.77)

Spinal Manipulation/Trigger Point Therapy vs Sham-spinal Manipulation: Mean Difference (Final Values): -0.24 (95% CI -0.78 to 0.30)

Primary outcome: IL-4 Serum Inflammatory Cytokine Levels

Time frame: From baseline to after 8th treatment at 4 weeks. Mean (Standard Deviation). Unit: pg/ML

Measure	Thoracic Spinal Manipulation/Trigger Point Therapy n = 11	Sham-spinal Manipulation Group n = 10
Value	83.85 (187.51)	73.36 (198.60)

Thoracic Spinal Manipulation/Trigger Point Therapy vs Sham-spinal Manipulation Group: Mean Difference (Final Values): -0.03 (95% CI -4.69 to 4.62)

Primary outcome: IL-10 Serum Inflammatory Cytokine Levels

Time frame: From baseline to after 8th treatment at 4 weeks. Mean (Standard Deviation). Unit: pg/ML

Measure	Thoracic Spinal Manipulation/Trigger Point Therapy n = 11	Sham-manipulation Group n = 10
Value	12.01 (25.01)	8.82 (17.14)

Thoracic Spinal Manipulation/Trigger Point Therapy vs Sham-manipulation Group: Mean Difference (Final Values): 0.15 (95% CI -1.32 to 1.85)

Primary outcome: IL-2 Serum Inflammatory Cytokine Levels

Time frame: From baseline to after 8th treatment at 4 weeks. Mean (Standard Deviation). Unit: pg/mL

Measure	Thoracic Spinal Manipulation & Trigger Point Therapy n = 11	Sham Manipulation Group n = 10
Value	0.13 (0.43)	0.01 (1.12)

Thoracic Spinal Manipulation & Trigger Point Therapy vs Sham Manipulation Group: Mean Difference (Final Values): 0.14 (95% CI -1.15 to 0.64)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Thoracic Spinal Manipulation/Trigger Point Therapy Group	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Sham-spinal Manipulation Group	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Limitations and caveats (from the sponsor): Limitations include: the exploratory nature and small sample size (n=21) of this pilot study which was not adequately powered for hypothesis testing, but designed to inform for future studies; the timing of blood collection at 20 minutes and 2 hours post-intervention may not have captured the immediate, earliest or most relevant changes in cytokine/chemokine levels related to spinal manipulation/trigger point therapy.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42028147Alanazi MS, Motl RW, Jones BA, Qu H, Li P, Reed WR. Effects of thoracic manipulation with trigger point therapy on inflammatory cytokine levels in individuals with multiple sclerosis: a pilot study. Front Rehabil Sci. 2026 Apr 8;7:1699274. doi: 10.3389/fresc.2026.1699274. eCollection 2026.

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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.

William R Reed, DC, PhD principal investigator

University of Alabama at Birmingham

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Spinal Manipulation in people with Multiple Sclerosis, Relapsing-Remitting, run by University of Alabama at Birmingham 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 9 inclusion and 3 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: finished, as of the sponsor's last update on 20 Jul 2026. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jul 2026). 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?

IL-6 Serum Inflammatory Cytokine Levels (time frame: From baseline to after 8th treatment at 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04972929, which also lists 1 linked publication.

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 20 Jul 2026.