Muscle AcidosisNCT04049253
The Causal Connection Between Sng and Muscle Acidosis
A study testing Phosphate Buffer Solution in people with Muscle Acidosis, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial summary
This proposed study suggests that peripheral tissue acidosis sensed by the somatosensory system (sngceptin) would evoke the sng perception in the brain. This hypothesis is based on investigators preliminary data that the peripheral muscle acidosis will evoked the central sng perception. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Acidosis
- What is being tested?
- Phosphate Buffer Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Jul 2019to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject ages ranges from 20-45 years old.
- The subject has no chronic pain symptoms or complaint in last 6 months.
- The subject is subjectively able to discriminate sng and pain.
- The subject has no history of major diseases that required treatment or currently being under treatment.
- Gender: men and women half
- The used hand of subject is the right hand.
Show all 11Show fewer
- The educational level of subject is more than 9 years (graduated from junior high school)
- The subject didn't have physical and mental illness
- The subject didn't take prescribed medicine.
- The VAS questionnaire must be 0 point both of low back "pain" and low back "soreness" assessment.
- The subject who can fill the informed consent after understanding the purpose and medical help of this trial.
Who cannot join
- The subject has: Neuropathic pain due to causes other than that specified in the inclusion criteria (e.g., post-herpetic neuralgia; painful diabetic neuropathy; mononeuritis multiplex; central poststroke pain; failed back surgery in relation to the presenting episode of radiculopathy; spinal abscess, infection, hematoma, or malignancy; phantom limb pain; peripheral neuropathy due to alcoholism, malignancy, human immunodeficiency virus [HIV], syphilis; drug abuse; vitamin B12 deficiency; hypothyroidism; liver disease; toxic exposure). Pain that is associated with a substantial somatic pain component (e.g., non-neuropathic/musculoskeletal pain in lower limbs or other parts of the body apart from the back) or more than one cause or potential cause for pain symptoms.Any painful concurrent rheumatic disease such as, but not limited to, fibromyalgia, rheumatoid arthritis, or significant osteoarthritis.
- The subject is unable to reliably delineate or assess his or her own pain by anatomical location/distribution (e.g., the subject cannot reliably tell the difference between his or her back pain and lower limb pain and cannot rate the intensity of each separately).
- The subject has undergone lumbar spine surgery within the last 6 months or has received treatment with epidural injections, nerve blocks, or acupuncture for lower skin electrical resistance within 4 weeks before screening.
- The subject had a malignancy according to his/her report.
- The subject had allergic to lidocaine or monobasic sodium phosphate and dibasic sodium phosphate
- The subject has had a positive test for HIV antibody or a history of HIV according to his/her report.
Show all 19Show fewer
- The subject has had a positive test for hepatitis B surface antigen or hepatitis C antibody according to his/her report.
- The subject has a history of alcohol or narcotic substance abuse according to his/her report.
- The subject is female and is pregnant or breastfeeding at the time of the screening visit or plans to become pregnant during the study period.
- The subject cannot perform brain MRI scanning who had metal implants of head (such as fixed dentures, metal bone plate, vascular clamp, vascular embolization treatment coil, deep brain stimulator, artificial electronic ear, etc.), implants of head which affecting the image quality (such as the ventricle peritoneal catheter, etc.), implantation of permanent heart rate regulator, etc.
- The subject has suffered from claustrophobia.
- The subject has a history of spinal surgery.
- The VAS questionnaire not be 0 point either low back "pain" or low back "soreness" assessment.
- The subject has mental comorbidity (such as depression, panic disorder, etc)
- The subject has suffered from brain disease and had brain surgery.
- The subject has taken prescribed medicine which can affect specific function of brian (such as sleeping pills, tranquilizer, etc.).
- The subject has mental retardation.
- The educational level of subject is less than 9 years.
- The subject who under 20 years old or older than 45 years old, who is unable to understand the purpose of this trial and fill the informed consent.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Hospital
Taipei, No.252, Wusing St., Sinyi Dist., 11031
Jiann-Her Lin, MD/PhD, +886973405133, jiannher@me.com
Jiann-Her Lin, MD/PhD
About this study
This proposed study suggests that peripheral tissue acidosis sensed by the somatosensory system (sngceptin) would evoke the sng perception in the brain. This hypothesis is based on investigators preliminary data that the peripheral muscle acidosis will evoked the central sng perception. This proposed study also identify the detection of brain activation areas related to the peripheral muscle acidosis. Investigators will know specific brain areas related to sng perception evoked by the peripheral muscle acidosis and, accordingly, a novel mechanism and potential treatment for sng would be developed in this proposed study.
Read the detailed description
Sng is a prominent complaint in Taiwanese people with low back pain. "Sng" is created to represent this Taiwanese word. Based on investigators preliminary data, sng was one of the most common complaints in patients with chronic low back pain (CLBP) and also one of the most common indication for lumbar spine operations. Back sng is not adequately relieved by pain-killers or even by the lumbar spine operations. By using functional magnetic resonance imaging and questionnaires, the investigators preliminary study demonstrated that sng is different from pain in the level of brain perception and the level of subjective concept. It is very likely that sng has its own unique nerve pathway other than pain. The subjective feeling of sng is very similar to sour in taste, so it is likely that acidosis may be involved in the process of sng sensation, especially in the muscle. Delayed onset muscle soreness is a well-known example, and the soreness is dependent on the proton-sensing neurons. Indeed, substantial evidences showed that up to 80% muscle afferents are acid-sensitive but not nociceptors. Therefore, the investigators propose that sng is the perception in the brain when the tissue acidosis is sensed by the somatosensory system, and "sng-ception" is created to indicate the sensation of tissue acidosis. However, the causal connection between the peripheral sngception and the central brain perception of sng is not established. The objective of this proposal is to establish the causal connection between peripheral muscle acidosis and the central brain sng perception. The investigators central hypothesis is that acidosis-evoked sensation in the muscles will cause a central sng perception in the brain. This hypothesis is based on investigators previous studies that showed sng is different from pain in terms of subjective responses, brain activation areas and clinical impacts. To achieve this goal, two specific aims will be pursued 1. to determine if an acid solution will evokes sng response, and, 2. to detect the brain activation area of sng evoked by an acid solution in functional magnetic resonance imaging. Successful establishment of the casual connection between the peripheral muscle acidosis and the central brain sng perception will lead to a more comprehensive understanding of sng mechanism and the potential medication development.
- Conditions
- Muscle Acidosis
- Being tested
- Phosphate Buffer Solution
- Keywords
- sngceptin, soreness, muscle acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phosphate Buffer SolutionDrug
Also called Sodium phosphate solution, Phosphate buffered saline
Phosphate-buffered saline (abbreviated PBS) is a buffer solution commonly used in biological research. It is a water-based salt solution containing disodium hydrogen phosphate, sodium dihydrogen phosphate. The buffer helps to maintain a constant pH. The osmolarity and ion concentrations of the solutions match those of the human body (isotonic).
| Study group | Role | What they receive |
|---|---|---|
| Acidic phosphate buffer solution | Experimental | pH5.2 phosphate buffer solution Receives: Drug: Phosphate Buffer Solution |
| Neutral phosphate buffer solution | Placebo comparator | pH7.4 phosphate buffer solution Receives: Drug: Phosphate Buffer Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain functional magnetic resonance imaging
All images will be acquired on a 3 Tesla MRI system (MAGNETOM Prisma, Siemens, Erlangen, Germany) with a 20-channel head coil. To obtain an anatomical reference, high-resolution T1-weighted imaging was performed using a 3D magnetization-prepared rapid gradient echo (MPRAGE) sequence: repetition time (TR)/echo time (TE) = 2000 ms/3 ms, flip angle = 9°, field of view (FOV) = 256 × 192 × 208 mm3, acquisition matrix = 256 × 192 × 208, resulting in isotropic spatial resolution of 1 mm3. The task fMRI will be performed using an echo planar imaging (EPI) sequence with a twice-refocused balanced echo. The imaging parameters are: TR/TE = 2000/20 ms, slice thickness = 3.5 mm, 80 × 80 acquisition matrix, FOV = 200 × 200 mm, and in-plane spatial resolution = 3.0 mm x 3.0 mm.
Measured: The whole procedures will be done within 50 minutes. Before the injection, the subject will receive anatomical MRI scan (10 minutes) and baseline fMRI scan (10 minutes) After that, the acid or pH 7.4 PBS will be given into the midpoint of the left tibial
Secondary outcomes (2)
The visual analog scale (VAS) of "sng" in the legs
The subject will be asked for sng VAS before infusion and immediately after infusion.
Scale range 0 to 10 (1)0: No Sng (2)1-3: Mild Sng (3)4-6: Moderate Sng (4)7-9: Severe Sng (5)10: Worst Sng imaginable
Measured: Through fMRI completion an average of 6 months
Muscle pressure pain threshold
Muscle pressure pain threshold on bilateral tibialis anterior muscles will be measured by algometer.
Measured: Through fMRI completion an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start11 Jul 2019
- Primary completion31 Jul 2021 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Muscle AcidosisStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiann-Her,Lin, Taipei Medical University Hospital
- Investigators
- Jiann-Her Lin, MD/PhD, Principal investigator, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049253
- Sponsor's protocol ID
- N201902030
- Status last verified
- Oct 2020
- First submitted
- 23 Jul 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Issberner U, Reeh PW, Steen KH. Pain due to tissue acidosis: a mechanism for inflammatory and ischemic myalgia? Neurosci Lett. 1996 Apr 26;208(3):191-4. doi: 10.1016/0304-3940(96)12576-3.
PubMed 8733302Law LAF, Sluka KA, McMullen T, Lee J, Arendt-Nielsen L, Graven-Nielsen T. Acidic buffer induced muscle pain evokes referred pain and mechanical hyperalgesia in humans. Pain. 2008 Nov 30;140(2):254-264. doi: 10.1016/j.pain.2008.08.014. Epub 2008 Oct 2.
PubMed 18835099Lin JH, Hung CH, Han DS, Chen ST, Lee CH, Sun WZ, Chen CC. Sensing acidosis: nociception or sngception? J Biomed Sci. 2018 Nov 29;25(1):85. doi: 10.1186/s12929-018-0486-5.
PubMed 30486810Fujii Y, Ozaki N, Taguchi T, Mizumura K, Furukawa K, Sugiura Y. TRP channels and ASICs mediate mechanical hyperalgesia in models of inflammatory muscle pain and delayed onset muscle soreness. Pain. 2008 Nov 30;140(2):292-304. doi: 10.1016/j.pain.2008.08.013. Epub 2008 Oct 1.
PubMed 18834667Chen CC, Wong CW. Neurosensory mechanotransduction through acid-sensing ion channels. J Cell Mol Med. 2013 Mar;17(3):337-49. doi: 10.1111/jcmm.12025. Epub 2013 Mar 14.
PubMed 23490035Chen WN, Lee CH, Lin SH, Wong CW, Sun WH, Wood JN, Chen CC. Roles of ASIC3, TRPV1, and NaV1.8 in the transition from acute to chronic pain in a mouse model of fibromyalgia. Mol Pain. 2014 Jun 23;10:40. doi: 10.1186/1744-8069-10-40.
PubMed 24957987
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Causal Connection Between Sng and Muscle Acidosis
- ClinicalTrials.gov ID
- NCT04049253
- Acronym / sponsor ID
- N201902030
- Conditions
- Muscle Acidosis
- Keywords
- sngceptin, soreness, muscle acidosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposed study suggests that peripheral tissue acidosis sensed by the somatosensory system (sngceptin) would evoke the sng perception in the brain. This hypothesis is based on investigators preliminary data that the peripheral muscle acidosis will evoked the central sng perception. This proposed study also identify the detection of brain activation areas related to the peripheral muscle acidosis. Investigators will know specific brain areas related to sng perception evoked by the peripheral muscle acidosis and, accordingly, a novel mechanism and potential treatment for sng would be developed in this proposed study.
Detailed description
Sng is a prominent complaint in Taiwanese people with low back pain. "Sng" is created to represent this Taiwanese word. Based on investigators preliminary data, sng was one of the most common complaints in patients with chronic low back pain (CLBP) and also one of the most common indication for lumbar spine operations. Back sng is not adequately relieved by pain-killers or even by the lumbar spine operations. By using functional magnetic resonance imaging and questionnaires, the investigators preliminary study demonstrated that sng is different from pain in the level of brain perception and the level of subjective concept. It is very likely that sng has its own unique nerve pathway other than pain. The subjective feeling of sng is very similar to sour in taste, so it is likely that acidosis may be involved in the process of sng sensation, especially in the muscle. Delayed onset muscle soreness is a well-known example, and the soreness is dependent on the proton-sensing neurons. Indeed, substantial evidences showed that up to 80% muscle afferents are acid-sensitive but not nociceptors. Therefore, the investigators propose that sng is the perception in the brain when the tissue acidosis is sensed by the somatosensory system, and "sng-ception" is created to indicate the sensation of tissue acidosis. However, the causal connection between the peripheral sngception and the central brain perception of sng is not established. The objective of this proposal is to establish the causal connection between peripheral muscle acidosis and the central brain sng perception. The investigators central hypothesis is that acidosis-evoked sensation in the muscles will cause a central sng perception in the brain. This hypothesis is based on investigators previous studies that showed sng is different from pain in terms of subjective responses, brain activation areas and clinical impacts. To achieve this goal, two specific aims will be pursued 1. to determine if an acid solution will evokes sng response, and, 2. to detect the brain activation area of sng evoked by an acid solution in functional magnetic resonance imaging. Successful establishment of the casual connection between the peripheral muscle acidosis and the central brain sng perception will lead to a more comprehensive understanding of sng mechanism and the potential medication development.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acidic phosphate buffer solution | Experimental | Drug: Phosphate Buffer SolutionpH5.2 phosphate buffer solution |
| Neutral phosphate buffer solution | Placebo comparator | Drug: Phosphate Buffer SolutionpH7.4 phosphate buffer solution |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- The subject ages ranges from 20-45 years old.
- The subject has no chronic pain symptoms or complaint in last 6 months.
- The subject is subjectively able to discriminate sng and pain.
- The subject has no history of major diseases that required treatment or currently being under treatment.
- Gender: men and women half
Key exclusion criteria (19 listed)
- The subject has: Neuropathic pain due to causes other than that specified in the inclusion criteria (e.g., post-herpetic neuralgia; painful diabetic neuropathy; mononeuritis multiplex; central poststroke pain; failed back surgery in relation to the presenting episode of radiculopathy; spinal abscess, infection, hematoma, or malignancy; phantom limb pain; peripheral neuropathy due to alcoholism, malignancy, human immunodeficiency virus [HIV], syphilis; drug abuse; vitamin B12 deficiency; hypothyroidism; liver disease; toxic exposure). Pain that is associated with a substantial somatic pain component (e.g., non-neuropathic/musculoskeletal pain in lower limbs or other parts of the body apart from the back) or more than one cause or potential cause for pain symptoms.Any painful concurrent rheumatic disease such as, but not limited to, fibromyalgia, rheumatoid arthritis, or significant osteoarthritis.
- The subject is unable to reliably delineate or assess his or her own pain by anatomical location/distribution (e.g., the subject cannot reliably tell the difference between his or her back pain and lower limb pain and cannot rate the intensity of each separately).
- The subject has undergone lumbar spine surgery within the last 6 months or has received treatment with epidural injections, nerve blocks, or acupuncture for lower skin electrical resistance within 4 weeks before screening.
- The subject had a malignancy according to his/her report.
- The subject had allergic to lidocaine or monobasic sodium phosphate and dibasic sodium phosphate
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 |
|---|---|---|
| Phosphate Buffer SolutionAlso: Sodium phosphate solution, Phosphate buffered salinePhosphate-buffered saline (abbreviated PBS) is a buffer solution commonly used in biological research. It is a water-based salt solution containing disodium hydrogen phosphate, sodium dihydrogen phosphate. The buffer helps to maintain a constant pH. The osmolarity and ion concentrations of the solutions match those of the human body (isotonic). | Drug | Acidic phosphate buffer solution, Neutral phosphate buffer solution |
Primary outcome
Brain functional magnetic resonance imaging
Time frame: The whole procedures will be done within 50 minutes. Before the injection, the subject will receive anatomical MRI scan (10 minutes) and baseline fMRI scan (10 minutes) After that, the acid or pH 7.4 PBS will be given into the midpoint of the left tibial
All images will be acquired on a 3 Tesla MRI system (MAGNETOM Prisma, Siemens, Erlangen, Germany) with a 20-channel head coil. To obtain an anatomical reference, high-resolution T1-weighted imaging was performed using a 3D magnetization-prepared rapid gradient echo (MPRAGE) sequence: repetition time (TR)/echo time (TE) = 2000 ms/3 ms, flip angle = 9°, field of view (FOV) = 256 × 192 × 208 mm3, acquisition matrix = 256 × 192 × 208, resulting in isotropic spatial resolution of 1 mm3. The task fMRI will be performed using an echo planar imaging (EPI) sequence with a twice-refocused balanced echo. The imaging parameters are: TR/TE = 2000/20 ms, slice thickness = 3.5 mm, 80 × 80 acquisition matrix, FOV = 200 × 200 mm, and in-plane spatial resolution = 3.0 mm x 3.0 mm.
2 secondary outcomes
The visual analog scale (VAS) of "sng" in the legs
Time frame: Through fMRI completion an average of 6 months
Muscle pressure pain threshold
Time frame: Through fMRI completion an average of 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 8733302Issberner U, Reeh PW, Steen KH. Pain due to tissue acidosis: a mechanism for inflammatory and ischemic myalgia? Neurosci Lett. 1996 Apr 26;208(3):191-4. doi: 10.1016/0304-3940(96)12576-3.
- Background: PubMed 18835099Law LAF, Sluka KA, McMullen T, Lee J, Arendt-Nielsen L, Graven-Nielsen T. Acidic buffer induced muscle pain evokes referred pain and mechanical hyperalgesia in humans. Pain. 2008 Nov 30;140(2):254-264. doi: 10.1016/j.pain.2008.08.014. Epub 2008 Oct 2.
- Background: PubMed 30486810Lin JH, Hung CH, Han DS, Chen ST, Lee CH, Sun WZ, Chen CC. Sensing acidosis: nociception or sngception? J Biomed Sci. 2018 Nov 29;25(1):85. doi: 10.1186/s12929-018-0486-5.
- Background: PubMed 18834667Fujii Y, Ozaki N, Taguchi T, Mizumura K, Furukawa K, Sugiura Y. TRP channels and ASICs mediate mechanical hyperalgesia in models of inflammatory muscle pain and delayed onset muscle soreness. Pain. 2008 Nov 30;140(2):292-304. doi: 10.1016/j.pain.2008.08.013. Epub 2008 Oct 1.
- Background: PubMed 23490035Chen CC, Wong CW. Neurosensory mechanotransduction through acid-sensing ion channels. J Cell Mol Med. 2013 Mar;17(3):337-49. doi: 10.1111/jcmm.12025. Epub 2013 Mar 14.
- Background: PubMed 24957987Chen WN, Lee CH, Lin SH, Wong CW, Sun WH, Wood JN, Chen CC. Roles of ASIC3, TRPV1, and NaV1.8 in the transition from acute to chronic pain in a mouse model of fibromyalgia. Mol Pain. 2014 Jun 23;10:40. doi: 10.1186/1744-8069-10-40.
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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.
Jiann-Her Lin, MD/PhD principal investigator
Taipei Medical University 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 Phosphate Buffer Solution in people with Muscle Acidosis, run by Taipei Medical University Hospital at 1 site in Taiwan.
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 11 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 8 Oct 2020. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiann-Her Lin, MD/PhD (+886973405133, jiannher@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain functional magnetic resonance imaging (time frame: The whole procedures will be done within 50 minutes. Before the injection, the subject will receive anatomical MRI scan (10 minutes) and baseline fMRI scan (10 minutes) After that, the acid or pH 7.4 PBS will be given into the midpoint of the left tibial). 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 NCT04049253, which also lists 6 linked publications.
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 8 Oct 2020.