FibromyalgiaNCT02064296

Neuroimaging Approaches to Deconstructing Acupuncture for Chronic Pain

A study testing Needle acupuncture (Traditional Acupuncture) and Laser acupuncture (Non-traditional Acupuncture) in people with Fibromyalgia, run by University of Michigan 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

The aim of this study is to evaluate the impact of electro-acupuncture in pain processing on patients with fibromyalgia (FM). The investigators hypothesize that electro-acupuncture is effective for FM because it functions as a desensitization therapy, which when applied repeatedly over multiple treatment sessions… Read more about this study

Who is it for?: Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Fibromyalgia
What is being tested?: Needle acupuncture (Traditional Acupuncture) and Laser acupuncture (Non-traditional Acupuncture)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: 1 siteUnited States
Study dates: Dec 2014to 22 Nov 2019
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 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Have self-reported FM symptoms for at least one year and also meet the Wolfe et al 2011 criteria for Fibromyalgia.
Continued presence of pain more than 50% of days.
Pain greater than a certain threshold on the Visual Analog Scale (VAS) for pain; 7-day recall; [Note: The VAS is widely used in clinical pain research and as such we chose to use it for inclusion criteria and for clinical pain assessment below. Within our group numerical ratings scales 0-100 are more commonly used in quantitative sensory assessment, and as such we chose to use NRS scales for evoked pain assessments below.]
Willing to limit the introduction of any new medications or treatment modalities for control of FM symptoms during the study.
Able to travel to the study site to receive acupuncture treatments up to two times weekly.
Over 18 and under 65 years of age.

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Right-handed.
Female.
Capable of giving written informed consent.
Over 18 and under 65 years of age.
Female.
Right-handed.
Do not have fibromyalgia or an associated pain disorder, including: migraine, temporomandibular joint disorder (TMJ), chronic pelvic pain (CPP), or chronic fatigue syndrome (CFS).
Pain less than a certain threshold on the Visual Analog Scale (VAS) for pain; 7-day recall
Willing to complete all study procedures.
Capable of giving written informed consent.

Who cannot join

Acupuncture within last 6-months.
Presence of a known coagulation abnormality, thrombocytopenia, or bleeding diathesis that may preclude the safe use of acupuncture.
Presence of a concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc., or any other chronic pain condition with pain greater than fibromyalgia pain.
Peripheral neuropathy of know cause that interferes with activities of daily living.
History of vascular surgery in lower limbs or current lower limb vascular dysfunction.
History of head injury with substantial loss of consciousness.

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Routine daily use of narcotic analgesics, marijuana or have a history of substance abuse in the past 24 months as determine by subject self-report.
Stimulant medications, such as those used to treat ADD/ADHD (e.g., amphetamine/ dextroamphetamine [Adderall®], methylphenidate, dextroamphetamine), or the fatigue associated with sleep apnea or shift work (e.g., modafinil), are excluded.
Concurrent participation in other therapeutic trials.
Pregnant or nursing.
Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years).
Contraindications to fcMRI, fMRI, or 1H-MRS methods. These may include but are not limited to: surgical clips, surgical staples, metal implants, and certain metallic dental material. [Note: a more formal description of contraindications for MRI is present in our DSM Plan].
Use of over the counter pain medications (NSAIDs, etc.) on the day of MRI scan.
Use of as needed narcotic pain medication 48 hours prior to MRI scan.
Current, habitual, or previous use within the last 12 months of artificial nails, nail enhancements, or nail extensions that cover any portion of either thumbnail. Exceptions, including brief and/or occasional use, may be permissible at the discretion of the principle investigator.
Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigator that would prevent satisfactory completion of the study protocol.
Contraindications to the Electrostimulator device: Participants with electrical implants (i.e. pacemakers, defibrillators), cardiac rhythmic disorders, seizure disorders, any skin disorder in the vicinity of the electrode or an malignant diseases in the region of application. (Fibromyalgia participants only)
Have a diagnosis of fibromyalgia or meet the Wolfe et al 2011 criteria for Fibromyalgia.
Presence of a concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc. that causes pain.
Routine daily use of narcotic analgesics, marijuana or have a history of substance abuse in the past 24 months as determine by subject self-report.
Stimulant medications, such as those used to treat ADD/ADHD (e.g., amphetamine/ dextroamphetamine [Adderall®], methylphenidate, dextroamphetamine), or the fatigue associated with sleep apnea or shift work (e.g., modafinil), are excluded.
Concurrent participation in other therapeutic trials.
Pregnant or nursing.
Peripheral neuropathy of know cause that interferes with activities of daily living.
History of vascular surgery in lower limbs or current lower limb vascular dysfunction.
History of head injury with substantial loss of consciousness.
Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years).
Contraindications to fcMRI, fMRI, or 1H-MRS methods. (see above section)
Use of over the counter pain medications (NSAIDs, etc.) on the day of MRI scan.
Use of as needed narcotic pain medication 48 hours prior to MRI scan.
Current, habitual, or previous use within the last 12 months of artificial nails, nail enhancements, or nail extensions that cover any portion of either thumbnail. Exceptions, including brief and/or occasional use, may be permissible at the discretion of the principle investigator.
Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigator that would prevent satisfactory completion of the study protocol.

Trial locations and contacts

1 site in 1 country.

United States1 site

Chronic Pain and Fatigue Research Center
Ann Arbor, Michigan, 48106

Other trials in United States

About this study

Read the detailed description

This study design has two components: 1) a cross sectional assessment of brain chemistry, connectivity and response to pain in healthy controls and age- and sex-matched fibromyalgia patients, and 2) a longitudinal assessment of the same outcomes in fibromyalgia patients randomized to either electro-acupuncture (EA) or laser acupuncture.

The investigators will evaluate 80 fibromyalgia patients who will receive acupuncture treatment twice a week for 4 weeks, for a total of 8 treatments. Baseline data from these patients will be compared to results from 40 pain-free controls.

Participants will undergo experimental pain assessments as well as brain neuroimaging.

Note added after completion of study data gathering: Within the registration in ClinicalTrials.gov and the informed consent, one arm was referred to as "non-traditional acupuncture". In fact, this was a control arm, receiving mock laser acupuncture (Vita Laser 650, Lhasa OMS). They received 2 treatments per week for 4 weeks. As consented, they were told, with IRB permission, that they were receiving non-traditional laser acupuncture. This deception was essential to maintaining scientific integrity of the masking.

The laser acupuncture device (Vita Laser 650, Lhasa OMS) was positioned over all of the same acupoints used in electro-acupuncture (EA), but was turned off during treatment sessions. There was no palpation prior to positioning these devices, and there was no physical contact between device and skin.

Conditions: Fibromyalgia
Being tested: Needle acupuncture (Traditional Acupuncture), Laser acupuncture (Non-traditional Acupuncture)
Keywords: Fibromyalgia Chronic Pain
Medical subject headings: Fibromyalgia

What participants receive

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

Needle acupuncture (Traditional Acupuncture)Device
This group will receive needle acupuncture at 3 pairs of sites. The needles will be stimulated with low intensity, low frequency electric current using a constant-current electro-acupuncture device (AS Super 4 digital needle stimulator).
Laser acupuncture (Non-traditional Acupuncture)Device
For non-traditional acupuncture, a laser acupuncture device (Vita Laser 650, Lhasa OMS) will be positioned over all of the same acupoints used in EA. There will be no palpation prior to positioning these devices, and there will be no physical contact between device and skin.

Study groups in NCT02064296
Study group	Role	What they receive
Controls	No intervention	Healthy pain free controls will be recruited for comparison with fibromyalgia patients.
Non-Traditional Acupuncture	Active comparator	40 fibromyalgia patients will be randomized to non-traditional laser acupuncture (Vita Laser 650, Lhasa OMS). They will receive 2 treatments per week for 4 weeks. Receives: Device: Laser acupuncture (Non-traditional Acupuncture)
Traditional Acupuncture	Active comparator	40 fibromyalgia patients will be randomized to receive electro acupuncture (AS Super 4 digital needle stimulator, Harmony Medical Co) . They will receive 2 treatments per week for 4 weeks. Receives: Device: Needle acupuncture (Traditional Acupuncture)

What is being measured

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

Brain Neurocircuitry Underlying Chronic Pain (Percent of Time of a Somato-sensory Cortex Coactivation Pattern)
Characterize the altered somatosensory-related neurocircuitry underlying chronic pain in FM, as shown by the difference in brain connectivity between healthy controls and FM patients as measured by FMRI (occurrence rate of co-activation pattern). For each arm, the coactivation pattern was assessed at rest and during a pressure pain stimulation.
This is measured by the percent of scan time that an individual's brain displayed a particular coactivation pattern related to the somatosensory system.
Measured: At baseline
Change in Brain Connectivity With Acupuncture Treatment
Brain connectivity will be assessed at baseline and following either electro-acupuncture or mock laser acupuncture. Primary somatosensory cortex to insula connectivity. (Z-stat) A positive Z score reflects positive correlation in FMRI signal between different between brain areas. A negative Z score represents anti-correlation between in FMRI signal between brain regions. These scores reflect either positive connectivity or inhibitory connectivity. A mean of 0 represents no correlation or connectivity between regions.
Measured: Baseline and 4 weeks

Secondary outcomes (2)

Change in Brain Neurochemistry of Combined Glutamate and Glutamine (Glx) Within the Anterior Insular Cortex With Acupuncture Treatment
Brain neurochemistry assessed at baseline and following either electro-acupuncture or mock laser acupuncture using proton magnetic resonance spectroscopy (1H-MRS) measures of combined glutamate and glutamine (Glx).
Measured: Baseline and 4 weeks
Change in Brain Neurochemistry of Gama-aminobutyric Acid (GABA) Within the Anterior Insular Cortex With Acupuncture Treatment
Brain neurochemistry assessed at baseline and following either electro-acupuncture or mock laser acupuncture using proton magnetic resonance spectroscopy (1H-MRS) measures gama-aminobutyric acid (GABA).
Measured: Baseline and 4 weeks

Timeline

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

Dec 201422 Nov 2019

First posted17 Feb 2014 (estimated)
Study startDec 2014
Primary completion22 Nov 2019
Study completion22 Nov 2019

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 FibromyalgiaStudies of the same condition, open and under way.
More trials run by University of MichiganThe 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: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02064296
Sponsor's protocol ID: AcuAfference
Other IDs: R01AT007550
Status last verified: Aug 2022
First submitted: 11 Feb 2014
Last updated: 22 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Murphy AE, Buchtel H, Mawla I, Ichesco E, Larkin T, Harte SE, Zhan E, Napadow V, Harris RE. Temporal Summation but Not Expectations of Pain Relief Predict Response to Acupuncture Treatment in Fibromyalgia. J Pain. 2024 Oct;25(10):104622. doi: 10.1016/j.jpain.2024.104622. Epub 2024 Jul 8.
PubMed 38986891

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 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neuroimaging Approaches to Deconstructing Acupuncture for Chronic Pain
ClinicalTrials.gov ID: NCT02064296
Acronym / sponsor ID: AcuAfference
Conditions: Fibromyalgia
Keywords: Fibromyalgia Chronic Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH), Massachusetts General Hospital
Study start: Dec 2014
Primary completion: 22 Nov 2019 (actual)
Study completion: 22 Nov 2019 (actual)
First posted: 17 Feb 2014 (estimated)
Results: Posted 22 Sep 2022

Clinical summary

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

Detailed description

Participants will undergo experimental pain assessments as well as brain neuroimaging.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Controls	No intervention	–Healthy pain free controls will be recruited for comparison with fibromyalgia patients.
Non-Traditional Acupuncture	Active comparator	Device: Laser acupuncture (Non-traditional Acupuncture)40 fibromyalgia patients will be randomized to non-traditional laser acupuncture (Vita Laser 650, Lhasa OMS). They will receive 2 treatments per week for 4 weeks.
Traditional Acupuncture	Active comparator	Device: Needle acupuncture (Traditional Acupuncture)40 fibromyalgia patients will be randomized to receive electro acupuncture (AS Super 4 digital needle stimulator, Harmony Medical Co) . They will receive 2 treatments per week for 4 weeks.

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Have self-reported FM symptoms for at least one year and also meet the Wolfe et al 2011 criteria for Fibromyalgia.
Continued presence of pain more than 50% of days.
Pain greater than a certain threshold on the Visual Analog Scale (VAS) for pain; 7-day recall; [Note: The VAS is widely used in clinical pain research and as such we chose to use it for inclusion criteria and for clinical pain assessment below. Within our group numerical ratings scales 0-100 are more commonly used in quantitative sensory assessment, and as such we chose to use NRS scales for evoked pain assessments below.]
Willing to limit the introduction of any new medications or treatment modalities for control of FM symptoms during the study.
Able to travel to the study site to receive acupuncture treatments up to two times weekly.

Key exclusion criteria (32 listed)

Acupuncture within last 6-months.
Presence of a known coagulation abnormality, thrombocytopenia, or bleeding diathesis that may preclude the safe use of acupuncture.
Presence of a concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc., or any other chronic pain condition with pain greater than fibromyalgia pain.
Peripheral neuropathy of know cause that interferes with activities of daily living.
History of vascular surgery in lower limbs or current lower limb vascular dysfunction.

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
Needle acupuncture (Traditional Acupuncture)This group will receive needle acupuncture at 3 pairs of sites. The needles will be stimulated with low intensity, low frequency electric current using a constant-current electro-acupuncture device (AS Super 4 digital needle stimulator).	Device	Traditional Acupuncture
Laser acupuncture (Non-traditional Acupuncture)For non-traditional acupuncture, a laser acupuncture device (Vita Laser 650, Lhasa OMS) will be positioned over all of the same acupoints used in EA. There will be no palpation prior to positioning these devices, and there will be no physical contact between device and skin.	Device	Non-Traditional Acupuncture

Primary outcome

Brain Neurocircuitry Underlying Chronic Pain (Percent of Time of a Somato-sensory Cortex Coactivation Pattern)
Time frame: At baseline
Characterize the altered somatosensory-related neurocircuitry underlying chronic pain in FM, as shown by the difference in brain connectivity between healthy controls and FM patients as measured by FMRI (occurrence rate of co-activation pattern). For each arm, the coactivation pattern was assessed at rest and during a pressure pain stimulation. This is measured by the percent of scan time that an individual's brain displayed a particular coactivation pattern related to the somatosensory system.
Change in Brain Connectivity With Acupuncture Treatment
Time frame: Baseline and 4 weeks
Brain connectivity will be assessed at baseline and following either electro-acupuncture or mock laser acupuncture. Primary somatosensory cortex to insula connectivity. (Z-stat) A positive Z score reflects positive correlation in FMRI signal between different between brain areas. A negative Z score represents anti-correlation between in FMRI signal between brain regions. These scores reflect either positive connectivity or inhibitory connectivity. A mean of 0 represents no correlation or connectivity between regions.

2 secondary outcomes

Change in Brain Neurochemistry of Combined Glutamate and Glutamine (Glx) Within the Anterior Insular Cortex With Acupuncture Treatment
Time frame: Baseline and 4 weeks
Change in Brain Neurochemistry of Gama-aminobutyric Acid (GABA) Within the Anterior Insular Cortex With Acupuncture Treatment
Time frame: Baseline and 4 weeks

Results and safety

Results posted to the registry on 22 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Controls	27	26
Mock Laser Acupuncture	39	39
Electro-Acupuncture	40	40

Primary outcome: Brain Neurocircuitry Underlying Chronic Pain (Percent of Time of a Somato-sensory Cortex Coactivation Pattern)

Time frame: At baseline. Mean (Standard Deviation). Unit: percentage of scan time

Measure	Healthy Controls n = 19	Fibromyalgia Patients n = 63
Sensorimotor co-activation pattern at rest	0.1281 (0.05229)	0.1190 (0.03835)
Salience network co-activation pattern at rest	0.1213 (0.05289)	0.1345 (0.04560)
Sensorimotor co-activation pattern at pressure pain	0.1328 (0.05213)	0.1362 (0.03972)
Salience network co-activation pattern at pressure pain	0.1121 (0.05065)	0.1054 (0.04662)

Healthy Controls: p = 0.3330, t-test, 2 sided
Healthy Controls: p = 0.6474, t-test, 2 sided
Fibromyalgia Patients: p <0.0001, t-test, 2 sided

Population analysed: Because this is at baseline (pre-treatment) all fibromyalgia patients are combined in a single analysis group. Some individuals' data was unable to be analyzed because of typical collection challenges (e.g. participant movement). Three participants were lost to follow-up. Four fibromyalgia patients were excluded due to: pain from shingles (N=1), starting Adderall treatment (N=1), inadequate treatments (N=1), and doubling pregabalin dosage (N=1), taking place during the study.

Primary outcome: Change in Brain Connectivity With Acupuncture Treatment

Time frame: Baseline and 4 weeks. Mean (Standard Deviation). Unit: Z - stat

Measure	Mock Laser Acupuncture n = 37	Traditional Acupuncture n = 32
Baseline	0.5492 (1.799)	-0.3013 (1.178)
Post-treatment (4 weeks)	-0.08589 (1.182)	1.125 (1.379)

Mock Laser Acupuncture: p = 0.0653, t-test, 2 sided
Traditional Acupuncture: p <0.0001, t-test, 2 sided

Population analysed: Of the 38 participants in each arm who completed the intervention, three participants from the traditional acupuncture arm and one from the mock laser acupuncture arm were excluded from analysis for reasons complicating treatment interpretation, (e.g. addition of a new pain symptom or addition of an external study treatment.) Three participants from the Traditional Acupuncture arm were excluded due to poor data quality at either the pre- or post-treatment scanning visit.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Controls	0 of 27 (0%)	0 of 27 (0%)	0 of 27
Non-Traditional (Mock) Acupuncture	0 of 39 (0%)	9 of 39 (23.1%)	0 of 39
Traditional Acupuncture	0 of 40 (0%)	22 of 40 (55%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38986891Murphy AE, Buchtel H, Mawla I, Ichesco E, Larkin T, Harte SE, Zhan E, Napadow V, Harris RE. Temporal Summation but Not Expectations of Pain Relief Predict Response to Acupuncture Treatment in Fibromyalgia. J Pain. 2024 Oct;25(10):104622. doi: 10.1016/j.jpain.2024.104622. Epub 2024 Jul 8.

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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.

Richard E Harris, PhD principal investigator

University of Michigan

Viataly Napadow, PhD principal investigator

Massachusetts General Hospital

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

Questions about this trial

What is this clinical trial studying?

A study testing Needle acupuncture (Traditional Acupuncture) and Laser acupuncture (Non-traditional Acupuncture) in people with Fibromyalgia, run by University of Michigan 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 16 inclusion and 32 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 22 Sep 2022. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Sep 2022). 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?

Brain Neurocircuitry Underlying Chronic Pain (Percent of Time of a Somato-sensory Cortex Coactivation Pattern) (time frame: At baseline). 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?

On the ClinicalTrials.gov record for NCT02064296, 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 22 Sep 2022.