Delayed Onset Muscle Soreness Experimentally InducedDOMEXNCT07880782
Clinical and MRI Characteristics of Delayed Onset Muscle Soreness (DOMS) of the Shoulder Rotator Muscles Induced by Eccentric Exercise: An Exploratory Prospective Experimental Study
A study testing Isokinetic dynamometer in people with Delayed Onset Muscle Soreness Experimentally Induced, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to characterize the clinical and radiological manifestations of delayed onset muscle soreness (DOMS) experimentally induced by an isokinetic eccentric contraction protocol targeting the shoulder rotator muscles in asymptomatic athletic subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Delayed Onset Muscle Soreness Experimentally Induced
- What is being tested?
- Isokinetic dynamometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male subjects aged 18 to 45,
- No hormone therapy for the transgender population,
- Asymptomatic dominant shoulder,
- Athletes who have been performing upper-body strength training at least once a week for the past 3 months,
- Patients with no symptoms or history of: humeral, clavicular, or scapular fractures; glenohumeral, acromioclavicular, or sternoclavicular dislocations; shoulder surgery within the past 6 months; calcification; inflammatory arthritis; and/or tendon disorders,
- Enrollment in a social security program,
- Provision of information to the patient and obtaining the patient's free and informed consent.
Who cannot join
- Shoulder pain or history of shoulder pain
- Cognitive impairments deemed moderate to severe by the investigator Cardiac conditions that contraindicate maximal exertion
- Language barriers preventing participation in a rehabilitation program or the completion of a reliable assessment
- Persons under legal guardianship, conservatorship, or other legal protection
- Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marie-Martine LEFEVRE-COLAU, MD,PhD contact
Lynda OUSSALAH contact
France1 site
GH Paris Centre, Assistance Publique - Hôpitaux de Paris
Paris, France, 75014
Marie Martine LEFEVRE-COLAU, MD.PhD, 06 30 48 08 93 ext. +33, marie-martine.lefevre-colau@aphp.fr
Maxime BROHAN, MD, 06 22 57 43 74 ext. +33, maxime.brohan@aphp.fr
About this study
The purpose of this study is to characterize the clinical and radiological manifestations of delayed onset muscle soreness (DOMS) experimentally induced by an isokinetic eccentric contraction protocol targeting the shoulder rotator muscles in asymptomatic athletic subjects.
Read the detailed description
In recent years, an increasing number of young athletes have reported shoulder pain and weakness following intense physical activity, particularly strength training. These symptoms may sometimes suggest neurological conditions, such as suprascapular nerve involvement, but in most cases they correspond to delayed onset muscle soreness (DOMS), a common and benign response to unaccustomed or intense exercise. DOMS typically occurs between 12 and 48 hours after exercise and is characterized by diffuse muscle pain, transient loss of strength, tenderness to palpation, and reduced muscle flexibility. Despite its high prevalence, the clinical and imaging characteristics of DOMS affecting the shoulder rotator muscles remain insufficiently described, which may lead to diagnostic uncertainty and inappropriate management. To address this gap, this study is based on an experimental model designed to reproducibly induce DOMS in a controlled setting in healthy, physically active young adults.
Participants will undergo a standardized isokinetic exercise protocol targeting the internal and external rotator muscles of the shoulder. After an initial familiarization phase with the isokinetic device, participants will perform a structured exercise session consisting of 8 sets of 10 repetitions of eccentric contractions in both internal and external rotation. The protocol is designed to induce muscle fatigue and reproducible DOMS through controlled eccentric loading. Magnetic resonance imaging (MRI) of the shoulder will be performed at predefined time points during the study to assess muscle changes induced by the eccentric exercise. Particular attention will be paid to signal changes on fluid-sensitive sequences (T2/STIR), which are expected to reflect muscle edema and inflammation associated with DOMS.
In parallel, a comprehensive clinical and functional assessment will be conducted throughout the study. This includes evaluation of pain intensity using a visual analog scale (VAS), measurement of active and passive range of motion, assessment of muscle strength, and evaluation of functional impact using validated questionnaires such as the Shoulder Pain and Disability Index (SPADI) and the QuickDASH.
No invasive procedures or therapeutic interventions are involved in this study. The protocol relies exclusively on controlled mechanical (eccentric) muscle loading and non-invasive imaging.
- Being tested
- Isokinetic dynamometer
- Keywords
- DOMS, Delayed Onset Muscle Soreness, Magnetic resonance imaging, Excentric movement, Isokinetic dynamometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isokinetic dynamometerDevice
A standardized series of 8 sets of 10 repetitions of internal and external shoulder rotations performed under eccentric contractions.
| Study group | Role | What they receive |
|---|---|---|
| DOMS | Experimental | Asymptomatic male athletes who have been performing upper-limb strength training at least once per week for the past 3 months. Receives: Device: Isokinetic dynamometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Clinical and MRI Assessment of DOMS Evolution in Shoulder Rotator Muscles
A composite endpoint combining quantitative clinical parameters and qualitative and semi-quantitative MRI parameters, allowing analysis of the temporal evolution of DOMS from baseline through the different follow-up phases.
Measured: 3 months
Secondary outcomes (5)
Physical Impairment: numeric verbal scale of pain
self-evaluated numeric verbal scale of pain, ranging from 0 to 10 (lesser is better)
Measured: Day4, Day9 to Day16, and 3 months
Physical Impairment : mobility of shoulder joints
Active and passive shoulder bilateral global mobility.
Active and passive shoulder bilateral scapulohumeral mobility:
Measured in antepulsion/ abduction in scapular plane/ lateral rotation and medial rotation
Measured: Day4, Day9 to Day16, and 3 months
Self-administered questionnaire assessing quality of life of the upper limb
Assesses the ability to perform 23 activities, the severity of symptoms 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales.
Scores range from 0 (no disability) to 100 (most severe disability). In addition there are two optional modules of four questions each, sporting or instrumental and employment activity.
Measured: Day4, Day9 to Day16, and 3 months
Shoulder Pain and Disability Index (SPADI)
Self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. Total score ranging from 0 (best) to 100 (worst).
Measured: Day4, Day9 to Day16, and 3 months
MRI Normalization Time
Qualitative and semi-quantitative assessment of MRI muscle abnormalities on sagittal, axial, and coronal T2 fat-saturated and T2 STIR sequences, including presence, intensity and distribution of muscle hyperintensity, number of muscles involved, and associated lesions.
Measured: Day4, Day9 to Day16, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Delayed Onset Muscle Soreness Experimentally InducedStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880782
- Sponsor's protocol ID
- APHP260672
- Other IDs
- ID-RCB
- Acronym
- DOMEX
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Connolly DA, Sayers SP, McHugh MP. Treatment and prevention of delayed onset muscle soreness. J Strength Cond Res. 2003 Feb;17(1):197-208. doi: 10.1519/1533-4287(2003)0172.0.co;2.
PubMed 12580677Cheung K, Hume P, Maxwell L. Delayed onset muscle soreness : treatment strategies and performance factors. Sports Med. 2003;33(2):145-64. doi: 10.2165/00007256-200333020-00005.
PubMed 12617692Hody S, Croisier JL, Bury T, Rogister B, Leprince P. Eccentric Muscle Contractions: Risks and Benefits. Front Physiol. 2019 May 3;10:536. doi: 10.3389/fphys.2019.00536. eCollection 2019.
PubMed 31130877Bennie JA, Shakespear-Druery J, De Cocker K. Muscle-strengthening Exercise Epidemiology: a New Frontier in Chronic Disease Prevention. Sports Med Open. 2020 Aug 26;6(1):40. doi: 10.1186/s40798-020-00271-w.
PubMed 32844333Tiidus PM. Estrogen and gender effects on muscle damage, inflammation, and oxidative stress. Can J Appl Physiol. 2000 Aug;25(4):274-87. doi: 10.1139/h00-022.
PubMed 10953066Clarkson PM, Hubal MJ. Exercise-induced muscle damage in humans. Am J Phys Med Rehabil. 2002 Nov;81(11 Suppl):S52-69. doi: 10.1097/00002060-200211001-00007.
PubMed 12409811Impellizzeri FM, Bizzini M, Rampinini E, Cereda F, Maffiuletti NA. Reliability of isokinetic strength imbalance ratios measured using the Cybex NORM dynamometer. Clin Physiol Funct Imaging. 2008 Mar;28(2):113-9. doi: 10.1111/j.1475-097X.2007.00786.x. Epub 2007 Dec 7.
PubMed 18070123Drouin JM, Valovich-mcLeod TC, Shultz SJ, Gansneder BM, Perrin DH. Reliability and validity of the Biodex system 3 pro isokinetic dynamometer velocity, torque and position measurements. Eur J Appl Physiol. 2004 Jan;91(1):22-9. doi: 10.1007/s00421-003-0933-0. Epub 2003 Sep 24.
PubMed 14508689Kannus P. Isokinetic evaluation of muscular performance: implications for muscle testing and rehabilitation. Int J Sports Med. 1994 Jan;15 Suppl 1:S11-8. doi: 10.1055/s-2007-1021104.
PubMed 8157377Friedmann-Bette B, Bauer T, Kinscherf R, Vorwald S, Klute K, Bischoff D, Muller H, Weber MA, Metz J, Kauczor HU, Bartsch P, Billeter R. Effects of strength training with eccentric overload on muscle adaptation in male athletes. Eur J Appl Physiol. 2010 Mar;108(4):821-36. doi: 10.1007/s00421-009-1292-2. Epub 2009 Nov 25.
PubMed 19937450Wilke J, Behringer M. Is "Delayed Onset Muscle Soreness" a False Friend? The Potential Implication of the Fascial Connective Tissue in Post-Exercise Discomfort. Int J Mol Sci. 2021 Aug 31;22(17):9482. doi: 10.3390/ijms22179482.
PubMed 34502387LeBlanc AD, Schneider VS, Evans HJ, Pientok C, Rowe R, Spector E; New Collective Author. Regional changes in muscle mass following 17 weeks of bed rest. J Appl Physiol (1985). 1992 Nov;73(5):2172-8. doi: 10.1152/jappl.1992.73.5.2172.
PubMed 1474100Hotfiel T, Freiwald J, Hoppe MW, et al. Update: Delayed Onset Muscle Soreness (DOMS) - muscle biomechanics, pathophysiology
Burkhart SS, Morgan CD, Kibler WB. The disabled throwing shoulder: spectrum of pathology Part I: pathoanatomy and biomechanics. Arthroscopy. 2003 Apr;19(4):404-20. doi: 10.1053/jars.2003.50128.
PubMed 12671624Escamilla RF, Yamashiro K, Paulos L, Andrews JR. Shoulder muscle activity and function in common shoulder rehabilitation exercises. Sports Med. 2009;39(8):663-85. doi: 10.2165/00007256-200939080-00004.
PubMed 19769415
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and MRI Characteristics of Delayed Onset Muscle Soreness (DOMS) of the Shoulder Rotator Muscles Induced by Eccentric Exercise: An Exploratory Prospective Experimental Study
- ClinicalTrials.gov ID
- NCT07880782
- Acronym / sponsor ID
- DOMEX / APHP260672
- Keywords
- DOMS, Delayed Onset Muscle Soreness, Magnetic resonance imaging, Excentric movement, Isokinetic dynamometer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 19 Oct 2026 (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.
The purpose of this study is to characterize the clinical and radiological manifestations of delayed onset muscle soreness (DOMS) experimentally induced by an isokinetic eccentric contraction protocol targeting the shoulder rotator muscles in asymptomatic athletic subjects.
Detailed description
In recent years, an increasing number of young athletes have reported shoulder pain and weakness following intense physical activity, particularly strength training. These symptoms may sometimes suggest neurological conditions, such as suprascapular nerve involvement, but in most cases they correspond to delayed onset muscle soreness (DOMS), a common and benign response to unaccustomed or intense exercise. DOMS typically occurs between 12 and 48 hours after exercise and is characterized by diffuse muscle pain, transient loss of strength, tenderness to palpation, and reduced muscle flexibility. Despite its high prevalence, the clinical and imaging characteristics of DOMS affecting the shoulder rotator muscles remain insufficiently described, which may lead to diagnostic uncertainty and inappropriate management. To address this gap, this study is based on an experimental model designed to reproducibly induce DOMS in a controlled setting in healthy, physically active young adults.
Participants will undergo a standardized isokinetic exercise protocol targeting the internal and external rotator muscles of the shoulder. After an initial familiarization phase with the isokinetic device, participants will perform a structured exercise session consisting of 8 sets of 10 repetitions of eccentric contractions in both internal and external rotation. The protocol is designed to induce muscle fatigue and reproducible DOMS through controlled eccentric loading. Magnetic resonance imaging (MRI) of the shoulder will be performed at predefined time points during the study to assess muscle changes induced by the eccentric exercise. Particular attention will be paid to signal changes on fluid-sensitive sequences (T2/STIR), which are expected to reflect muscle edema and inflammation associated with DOMS.
In parallel, a comprehensive clinical and functional assessment will be conducted throughout the study. This includes evaluation of pain intensity using a visual analog scale (VAS), measurement of active and passive range of motion, assessment of muscle strength, and evaluation of functional impact using validated questionnaires such as the Shoulder Pain and Disability Index (SPADI) and the QuickDASH.
No invasive procedures or therapeutic interventions are involved in this study. The protocol relies exclusively on controlled mechanical (eccentric) muscle loading and non-invasive imaging.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DOMS | Experimental | Device: Isokinetic dynamometerAsymptomatic male athletes who have been performing upper-limb strength training at least once per week for the past 3 months. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male subjects aged 18 to 45,
- No hormone therapy for the transgender population,
- Asymptomatic dominant shoulder,
- Athletes who have been performing upper-body strength training at least once a week for the past 3 months,
- Patients with no symptoms or history of: humeral, clavicular, or scapular fractures; glenohumeral, acromioclavicular, or sternoclavicular dislocations; shoulder surgery within the past 6 months; calcification; inflammatory arthritis; and/or tendon disorders,
Key exclusion criteria (5 listed)
- Shoulder pain or history of shoulder pain
- Cognitive impairments deemed moderate to severe by the investigator Cardiac conditions that contraindicate maximal exertion
- Language barriers preventing participation in a rehabilitation program or the completion of a reliable assessment
- Persons under legal guardianship, conservatorship, or other legal protection
- Refusal to participate
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 |
|---|---|---|
| Isokinetic dynamometerA standardized series of 8 sets of 10 repetitions of internal and external shoulder rotations performed under eccentric contractions. | Device | DOMS |
Primary outcome
Composite Clinical and MRI Assessment of DOMS Evolution in Shoulder Rotator Muscles
Time frame: 3 months
A composite endpoint combining quantitative clinical parameters and qualitative and semi-quantitative MRI parameters, allowing analysis of the temporal evolution of DOMS from baseline through the different follow-up phases.
5 secondary outcomes
Physical Impairment: numeric verbal scale of pain
Time frame: Day4, Day9 to Day16, and 3 months
Physical Impairment : mobility of shoulder joints
Time frame: Day4, Day9 to Day16, and 3 months
Self-administered questionnaire assessing quality of life of the upper limb
Time frame: Day4, Day9 to Day16, and 3 months
Shoulder Pain and Disability Index (SPADI)
Time frame: Day4, Day9 to Day16, and 3 months
MRI Normalization Time
Time frame: Day4, Day9 to Day16, and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Background: PubMed 12580677Connolly DA, Sayers SP, McHugh MP. Treatment and prevention of delayed onset muscle soreness. J Strength Cond Res. 2003 Feb;17(1):197-208. doi: 10.1519/1533-4287(2003)0172.0.co;2.
- Background: PubMed 12617692Cheung K, Hume P, Maxwell L. Delayed onset muscle soreness : treatment strategies and performance factors. Sports Med. 2003;33(2):145-64. doi: 10.2165/00007256-200333020-00005.
- Background: PubMed 31130877Hody S, Croisier JL, Bury T, Rogister B, Leprince P. Eccentric Muscle Contractions: Risks and Benefits. Front Physiol. 2019 May 3;10:536. doi: 10.3389/fphys.2019.00536. eCollection 2019.
- Background: PubMed 32844333Bennie JA, Shakespear-Druery J, De Cocker K. Muscle-strengthening Exercise Epidemiology: a New Frontier in Chronic Disease Prevention. Sports Med Open. 2020 Aug 26;6(1):40. doi: 10.1186/s40798-020-00271-w.
- Background: PubMed 10953066Tiidus PM. Estrogen and gender effects on muscle damage, inflammation, and oxidative stress. Can J Appl Physiol. 2000 Aug;25(4):274-87. doi: 10.1139/h00-022.
- Background: PubMed 12409811Clarkson PM, Hubal MJ. Exercise-induced muscle damage in humans. Am J Phys Med Rehabil. 2002 Nov;81(11 Suppl):S52-69. doi: 10.1097/00002060-200211001-00007.
- Background: PubMed 18070123Impellizzeri FM, Bizzini M, Rampinini E, Cereda F, Maffiuletti NA. Reliability of isokinetic strength imbalance ratios measured using the Cybex NORM dynamometer. Clin Physiol Funct Imaging. 2008 Mar;28(2):113-9. doi: 10.1111/j.1475-097X.2007.00786.x. Epub 2007 Dec 7.
- Background: PubMed 14508689Drouin JM, Valovich-mcLeod TC, Shultz SJ, Gansneder BM, Perrin DH. Reliability and validity of the Biodex system 3 pro isokinetic dynamometer velocity, torque and position measurements. Eur J Appl Physiol. 2004 Jan;91(1):22-9. doi: 10.1007/s00421-003-0933-0. Epub 2003 Sep 24.
- Background: PubMed 8157377Kannus P. Isokinetic evaluation of muscular performance: implications for muscle testing and rehabilitation. Int J Sports Med. 1994 Jan;15 Suppl 1:S11-8. doi: 10.1055/s-2007-1021104.
- Background: PubMed 19937450Friedmann-Bette B, Bauer T, Kinscherf R, Vorwald S, Klute K, Bischoff D, Muller H, Weber MA, Metz J, Kauczor HU, Bartsch P, Billeter R. Effects of strength training with eccentric overload on muscle adaptation in male athletes. Eur J Appl Physiol. 2010 Mar;108(4):821-36. doi: 10.1007/s00421-009-1292-2. Epub 2009 Nov 25.
- Background: PubMed 34502387Wilke J, Behringer M. Is "Delayed Onset Muscle Soreness" a False Friend? The Potential Implication of the Fascial Connective Tissue in Post-Exercise Discomfort. Int J Mol Sci. 2021 Aug 31;22(17):9482. doi: 10.3390/ijms22179482.
- Background: PubMed 1474100LeBlanc AD, Schneider VS, Evans HJ, Pientok C, Rowe R, Spector E; New Collective Author. Regional changes in muscle mass following 17 weeks of bed rest. J Appl Physiol (1985). 1992 Nov;73(5):2172-8. doi: 10.1152/jappl.1992.73.5.2172.
- Individual participant dataSharing planned: No
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.
Marie-Martine LEFEVRE-COLAU, MD,PhD contact
Lynda OUSSALAH contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isokinetic dynamometer in people with Delayed Onset Muscle Soreness Experimentally Induced, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 19 Oct 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Martine LEFEVRE-COLAU, MD,PhD (06 30 48 08 93 ext. +33, marie-martine.lefevre-colau@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Clinical and MRI Assessment of DOMS Evolution in Shoulder Rotator Muscles (time frame: 3 months). 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 NCT07880782, which also lists 33 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 19 Oct 2026.