Temporomandibular Joint Disorder BilateralPhase 2/3TMDNCT05651256
Efficacy of Botulinum Toxin in Temporomandibular Disorders
A Phase 2/3 study testing Botulinum toxin type A injection in people with Temporomandibular Joint Disorder Bilateral, run by University of Salamanca at 1 site in Spain.
Trial summary
Temporomandibular disorders (TMDs) represent a multifactorial pathological group that gives rise to a varied and complex symptomatology that includes decreased jaw movement, muscle and joint pain, joint crepitation and limitation or functional deviation of the jaw opening. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorder Bilateral
- What is being tested?
- Botulinum toxin type A injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2021to 30 Jul 2021
- Phase
- Phase 2/3
- 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 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The study included patients diagnosed with TMDs, according to the established diagnostic criteria, aged between 18 and 69 years (both included) and with unilateral painful symptomatology of more than three months' duration.
Who cannot join
- Patients previously treated with surgery/arthrocentesis of the TMJ; patients treated in the last six months with surgery in the cervicofacial region; patients who, at the time of inclusion in the study, were being treated in a "Pain Unit" and patients who had previously received treatment with BTX.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clinica Odontológica de la Universidad de Salamanca
Salamanca, 37007
About this study
Official title: Preliminary Findings of the Efficacy of Botulinum Toxin in Temporomandibular Disorders: A Randomized Clinical Trial
Temporomandibular disorders (TMDs) represent a multifactorial pathological group that gives rise to a varied and complex symptomatology that includes decreased jaw movement, muscle and joint pain, joint crepitation and limitation or functional deviation of the jaw opening.
All this is sometimes accompanied by headache and other painful symptoms in the neck musculature, incapacitating for many patients and at considerable public health expense. Intramuscular and intra-articular injections of botulinum toxin are a simple treatment that has proven to be effective in the treatment of the painful symptoms of these disorders, being a therapeutic option in situations of failure of conventional treatments, without presenting adverse effects.
Our study presents the preliminary results of twenty patients treated with this therapy
Read the detailed description
TMDs are a common pathology affecting up to 70% of the population, with a maximum incidence in young patients. We used a sample of twenty patients recruited in the Maxillofacial Surgery Service of the University Hospital of Salamanca (Spain), who met the inclusion criteria, with unilateral painful symptomatology of more than three months duration. All patients were randomly treated by intramuscular and intra-articular injections of BTX (100 U) in 8 predetermined points. Pain symptomatology was assessed at the different locations, together with joint symptomatology, at baseline and 6 weeks after treatment.
Adverse effects were also evaluated. In 85% of the patients, pain on oral opening improved and 90% showed improvement of pain on mastication. A 75% of the patients reported improvement in joint clicking/noise. Headaches improved or disappeared in 70% of the patients treated. Despite the limitations of the study and the preliminary results, intramuscular and intra-articular infiltrations with BTX were effective in the treatment of symptoms associated with TMDs, with minimal adverse effects.
- Being tested
- Botulinum toxin type A injection
- Keywords
- Botulinum toxin, Temporomandibular joint disorders, Masticatory disfunction syndrome, Randomized clinical trial
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type A injectionDrug
Also called Botox® 100 U, Allergan Pharmaceuticals Westport, Ireland
The solution for injection was prepared immediately before the intervention, by dissolving the vials of BTX, kept refrigerated at 5ºC, in 1 ml of sterile saline solution at room temperature. Eight injection sites were marked, three located in the masseter muscle, two in the lateral pterygoid muscle, one in the temporomandibular joint (TMJ) and two in the temporalis muscle. A 1 cc marked insulin syringe was used for intramuscular injection of the prepared solution, according to the locations and amounts proposed by Kim et al. and Ho et al. with a total dose of 100 U in each patient.distributed at the different injection sites.
| Study group | Role | What they receive |
|---|---|---|
| TREATMENT | Experimental | BEFORE TREATMENT/AFTER TREATMENT A 1 cc marked insulin syringe was used for intramuscular injection of the prepared solution, according to the locations and amounts proposed with a total dose of 100 U (Type A toxinum botulinum, Allergan) in each patient, distributed at the different injection sites: 40 U in the masseter muscle, (0.1 cc=10 U), 20 U in the area of greatest hypertrophy (anterior inferior masseter), 10 U in the direction of the mandibular inferior border and 10 U in the area of the posterior inferior masseter; 20 U in the lateral pterygoid muscle (10 U extraorally between the zygomatic arch and sigmoid notch and 10 U intraorally, behind the maxillary tuberosity); 20 U in the TMJ, 10mm anterior to the tragus and 2mm below the zygomatic arch and 20 U in the anterior part of the temporalis muscle. Receives: Drug: Botulinum toxin type A injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of pain intensity in the masticatory musculature
Pain intensity was evaluated through the visual analogue scale (VAS). The patients determined the intensity of pain in the different locations of the craniofacial region (temporal muscle, masseter muscle, pterygoid muscle, and TMJ) in a range of 0 to 10, before and after the administration of botulinum toxin.
0 was the absence of pain and 10 the intensity of maximum pain. The percentage of patients in whom the pain intensity of the masticatory muscles decreased after treatment with botox type A was analyzed.
Measured: 6 weeks
Complications in the administration of botulinum toxin
Adverse side effects assessed included warmth, redness, and bruising at the injection site, swallowing disturbance, contracture or pain of the contralateral muscle, and abnormal jaw movements.
Therefore, the percentage of patients included in the study who presented complications after the injection of botulinum toxin according to the established parameters was analyzed.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Mar 2021
- Primary completion30 Mar 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint Disorder BilateralStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- clinical trial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JAVIER MONTERO, University of Salamanca
- Investigators
- JAVIER MONTERO, PROFESSOR, Study director, Salamanca University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651256
- Sponsor's protocol ID
- PI 2021 04 734
- Acronym
- TMD
- Status last verified
- Dec 2022
- First submitted
- 15 Nov 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
PubMed 24482784Okeson JP. Current terminology and diagnostic classification schemes. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1997 Jan;83(1):61-4. doi: 10.1016/s1079-2104(97)90092-5.
PubMed 9007925Liu F, Steinkeler A. Epidemiology, diagnosis, and treatment of temporomandibular disorders. Dent Clin North Am. 2013 Jul;57(3):465-79. doi: 10.1016/j.cden.2013.04.006.
PubMed 23809304Kobayashi FY, Gaviao MB, Montes AB, Marquezin MC, Castelo PM. Evaluation of oro-facial function in young subjects with temporomandibular disorders. J Oral Rehabil. 2014 Jul;41(7):496-506. doi: 10.1111/joor.12163. Epub 2014 Mar 24.
PubMed 24661101Baba K, Tsukiyama Y, Yamazaki M, Clark GT. A review of temporomandibular disorder diagnostic techniques. J Prosthet Dent. 2001 Aug;86(2):184-94. doi: 10.1067/mpr.2001.116231.
PubMed 11514808Gauer RL, Semidey MJ. Diagnosis and treatment of temporomandibular disorders. Am Fam Physician. 2015 Mar 15;91(6):378-86.
PubMed 25822556Lomas J, Gurgenci T, Jackson C, Campbell D. Temporomandibular dysfunction. Aust J Gen Pract. 2018 Apr;47(4):212-215. doi: 10.31128/AFP-10-17-4375.
PubMed 29621862Shoohanizad E, Garajei A, Enamzadeh A, Yari A. Nonsurgical management of temporomandibular joint autoimmune disorders. AIMS Public Health. 2019 Dec 12;6(4):554-567. doi: 10.3934/publichealth.2019.4.554. eCollection 2019.
PubMed 31909075Ta LE, Dionne RA. Treatment of painful temporomandibular joints with a cyclooxygenase-2 inhibitor: a randomized placebo-controlled comparison of celecoxib to naproxen. Pain. 2004 Sep;111(1-2):13-21. doi: 10.1016/j.pain.2004.04.029.
PubMed 15327804Herman CR, Schiffman EL, Look JO, Rindal DB. The effectiveness of adding pharmacologic treatment with clonazepam or cyclobenzaprine to patient education and self-care for the treatment of jaw pain upon awakening: a randomized clinical trial. J Orofac Pain. 2002 Winter;16(1):64-70.
PubMed 11889661Hersh EV, Balasubramaniam R, Pinto A. Pharmacologic management of temporomandibular disorders. Oral Maxillofac Surg Clin North Am. 2008 May;20(2):197-210, vi. doi: 10.1016/j.coms.2007.12.005.
PubMed 18343325Park J, Park HJ. Botulinum Toxin for the Treatment of Neuropathic Pain. Toxins (Basel). 2017 Aug 24;9(9):260. doi: 10.3390/toxins9090260.
PubMed 28837075Fallah HM, Currimbhoy S. Use of botulinum toxin A for treatment of myofascial pain and dysfunction. J Oral Maxillofac Surg. 2012 May;70(5):1243-5. doi: 10.1016/j.joms.2012.01.015. No abstract available.
PubMed 22538024Patel J, Cardoso JA, Mehta S. A systematic review of botulinum toxin in the management of patients with temporomandibular disorders and bruxism. Br Dent J. 2019 May;226(9):667-672. doi: 10.1038/s41415-019-0257-z.
PubMed 31076698Serrera-Figallo MA, Ruiz-de-Leon-Hernandez G, Torres-Lagares D, Castro-Araya A, Torres-Ferrerosa O, Hernandez-Pacheco E, Gutierrez-Perez JL. Use of Botulinum Toxin in Orofacial Clinical Practice. Toxins (Basel). 2020 Feb 11;12(2):112. doi: 10.3390/toxins12020112.
PubMed 32053883
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Findings of the Efficacy of Botulinum Toxin in Temporomandibular Disorders: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05651256
- Acronym / sponsor ID
- TMD / PI 2021 04 734
- Keywords
- Botulinum toxin, Temporomandibular joint disorders, Masticatory disfunction syndrome, Randomized clinical trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 14 Dec 2022 (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.
Temporomandibular disorders (TMDs) represent a multifactorial pathological group that gives rise to a varied and complex symptomatology that includes decreased jaw movement, muscle and joint pain, joint crepitation and limitation or functional deviation of the jaw opening.
All this is sometimes accompanied by headache and other painful symptoms in the neck musculature, incapacitating for many patients and at considerable public health expense. Intramuscular and intra-articular injections of botulinum toxin are a simple treatment that has proven to be effective in the treatment of the painful symptoms of these disorders, being a therapeutic option in situations of failure of conventional treatments, without presenting adverse effects.
Our study presents the preliminary results of twenty patients treated with this therapy
Detailed description
TMDs are a common pathology affecting up to 70% of the population, with a maximum incidence in young patients. We used a sample of twenty patients recruited in the Maxillofacial Surgery Service of the University Hospital of Salamanca (Spain), who met the inclusion criteria, with unilateral painful symptomatology of more than three months duration. All patients were randomly treated by intramuscular and intra-articular injections of BTX (100 U) in 8 predetermined points. Pain symptomatology was assessed at the different locations, together with joint symptomatology, at baseline and 6 weeks after treatment.
Adverse effects were also evaluated. In 85% of the patients, pain on oral opening improved and 90% showed improvement of pain on mastication. A 75% of the patients reported improvement in joint clicking/noise. Headaches improved or disappeared in 70% of the patients treated. Despite the limitations of the study and the preliminary results, intramuscular and intra-articular infiltrations with BTX were effective in the treatment of symptoms associated with TMDs, with minimal adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- clinical trial
| Arm | Type | Receives |
|---|---|---|
| TREATMENT | Experimental | Drug: Botulinum toxin type A injectionBEFORE TREATMENT/AFTER TREATMENT A 1 cc marked insulin syringe was used for intramuscular injection of the prepared solution, according to the locations and amounts proposed with a total dose of 100 U (Type A toxinum botulinum, Allergan) in each patient, distributed at the different injection sites: 40 U in the masseter muscle, (0.1 cc=10 U), 20 U in the area of greatest hypertrophy (anterior inferior masseter), 10 U in the direction of the mandibular inferior border and 10 U in the area of the posterior inferior masseter; 20 U in the lateral pterygoid muscle (10 U extraorally between the zygomatic arch and sigmoid notch and 10 U intraorally, behind the maxillary tuberosity); 20 U in the TMJ, 10mm anterior to the tragus and 2mm below the zygomatic arch and 20 U in the anterior part of the temporalis muscle. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study included patients diagnosed with TMDs, according to the established diagnostic criteria, aged between 18 and 69 years (both included) and with unilateral painful symptomatology of more than three months' duration.
Key exclusion criteria (1 listed)
- Patients previously treated with surgery/arthrocentesis of the TMJ; patients treated in the last six months with surgery in the cervicofacial region; patients who, at the time of inclusion in the study, were being treated in a "Pain Unit" and patients who had previously received treatment with BTX.
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 |
|---|---|---|
| Botulinum toxin type A injectionAlso: Botox® 100 U, Allergan Pharmaceuticals Westport, IrelandThe solution for injection was prepared immediately before the intervention, by dissolving the vials of BTX, kept refrigerated at 5ºC, in 1 ml of sterile saline solution at room temperature. Eight injection sites were marked, three located in the masseter muscle, two in the lateral pterygoid muscle, one in the temporomandibular joint (TMJ) and two in the temporalis muscle. A 1 cc marked insulin syringe was used for intramuscular injection of the prepared solution, according to the locations and amounts proposed by Kim et al. and Ho et al. with a total dose of 100 U in each patient.distributed at the different injection sites. | Drug | TREATMENT |
Primary outcome
Measurement of pain intensity in the masticatory musculature
Time frame: 6 weeks
Pain intensity was evaluated through the visual analogue scale (VAS). The patients determined the intensity of pain in the different locations of the craniofacial region (temporal muscle, masseter muscle, pterygoid muscle, and TMJ) in a range of 0 to 10, before and after the administration of botulinum toxin. 0 was the absence of pain and 10 the intensity of maximum pain. The percentage of patients in whom the pain intensity of the masticatory muscles decreased after treatment with botox type A was analyzed.
Complications in the administration of botulinum toxin
Time frame: 6 weeks
Adverse side effects assessed included warmth, redness, and bruising at the injection site, swallowing disturbance, contracture or pain of the contralateral muscle, and abnormal jaw movements. Therefore, the percentage of patients included in the study who presented complications after the injection of botulinum toxin according to the established parameters was analyzed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Background: PubMed 24482784Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
- Background: PubMed 9007925Okeson JP. Current terminology and diagnostic classification schemes. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1997 Jan;83(1):61-4. doi: 10.1016/s1079-2104(97)90092-5.
- Background: PubMed 23809304Liu F, Steinkeler A. Epidemiology, diagnosis, and treatment of temporomandibular disorders. Dent Clin North Am. 2013 Jul;57(3):465-79. doi: 10.1016/j.cden.2013.04.006.
- Background: PubMed 24661101Kobayashi FY, Gaviao MB, Montes AB, Marquezin MC, Castelo PM. Evaluation of oro-facial function in young subjects with temporomandibular disorders. J Oral Rehabil. 2014 Jul;41(7):496-506. doi: 10.1111/joor.12163. Epub 2014 Mar 24.
- Background: PubMed 11514808Baba K, Tsukiyama Y, Yamazaki M, Clark GT. A review of temporomandibular disorder diagnostic techniques. J Prosthet Dent. 2001 Aug;86(2):184-94. doi: 10.1067/mpr.2001.116231.
- Background: PubMed 25822556Gauer RL, Semidey MJ. Diagnosis and treatment of temporomandibular disorders. Am Fam Physician. 2015 Mar 15;91(6):378-86.
- Background: PubMed 29621862Lomas J, Gurgenci T, Jackson C, Campbell D. Temporomandibular dysfunction. Aust J Gen Pract. 2018 Apr;47(4):212-215. doi: 10.31128/AFP-10-17-4375.
- Background: PubMed 31909075Shoohanizad E, Garajei A, Enamzadeh A, Yari A. Nonsurgical management of temporomandibular joint autoimmune disorders. AIMS Public Health. 2019 Dec 12;6(4):554-567. doi: 10.3934/publichealth.2019.4.554. eCollection 2019.
- Background: PubMed 15327804Ta LE, Dionne RA. Treatment of painful temporomandibular joints with a cyclooxygenase-2 inhibitor: a randomized placebo-controlled comparison of celecoxib to naproxen. Pain. 2004 Sep;111(1-2):13-21. doi: 10.1016/j.pain.2004.04.029.
- Background: PubMed 11889661Herman CR, Schiffman EL, Look JO, Rindal DB. The effectiveness of adding pharmacologic treatment with clonazepam or cyclobenzaprine to patient education and self-care for the treatment of jaw pain upon awakening: a randomized clinical trial. J Orofac Pain. 2002 Winter;16(1):64-70.
- Background: PubMed 18343325Hersh EV, Balasubramaniam R, Pinto A. Pharmacologic management of temporomandibular disorders. Oral Maxillofac Surg Clin North Am. 2008 May;20(2):197-210, vi. doi: 10.1016/j.coms.2007.12.005.
- Background: PubMed 28837075Park J, Park HJ. Botulinum Toxin for the Treatment of Neuropathic Pain. Toxins (Basel). 2017 Aug 24;9(9):260. doi: 10.3390/toxins9090260.
- 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. This study is not recruiting at the moment.
JAVIER MONTERO, PROFESSOR study director
Salamanca University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Botulinum toxin type A injection in people with Temporomandibular Joint Disorder Bilateral, run by University of Salamanca at 1 site in Spain.
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 1 inclusion and 1 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 14 Dec 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 Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measurement of pain intensity in the masticatory musculature (time frame: 6 weeks). 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 NCT05651256, which also lists 48 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 14 Dec 2022.