Chronic PainBvsBNCT05617118
BTA vs Baclofen for Pelvic Myofascial Pain Syndrome
An observational study of Chronic Pain and Chronic Pelvic Pain Syndrome, run by Saint Petersburg State University, Russia at 1 site in Russia.
Trial summary
The aim of the study is to test the hypothesis that oral taking of baclofen in therapeutic dosage for 60 days is equally effective as injection of botulinum toxin type "A" in the area of trigger points of the pelvic muscles. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain, Chronic Pelvic Pain Syndrome, Myofascial Pain Syndrome
- What is being tested?
- Baclofen 10mg and Botulinum toxin type A
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 52 participants
- Where
- 1 siteRussia
- Study dates
- 1 Dec 2022to 1 May 2024
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with long-term chronic pelvic pain syndrome who have not previously received targeted treatment for myofascial pelvic pain syndrome
Who may be able to join
- Myofascial pain syndrome (presence of trigger points), confirmed by palpation during examination.
- Ineffectiveness (with subsequent discontinuation) of at least one treatment method, including outpatient physiotherapy and /or oral analgesics, or NSAIDs.
Who cannot join
- The presence of any organic disease of the pelvic organs requiring active treatment, confirmed by anamnesis, consultation of a specialist (urologist, proctologist, gynecologist) and one of the objective imaging methods: CT, MRI, endoscopical or laboratory methods: general urine analysis or prostate secretion analysis. Such diseases include interstitial cystitis / SBMP, chronic prostatitis types I, II, IIIA according to the NIH classification.
- The presence in the anamnesis of the fact of previously conducted therapy with baclofen or injection of botulinum toxin type "A" into the pelvic floor muscles.
- Individual intolerance to botulinum toxin type "A" and /or baclofen.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Efficacy and Safety of Oral Baclofen Taking in Comparison With Botulinum Toxin A Injections in Myofascial Pelvic Pain Syndrome. Prospective Multicenter Cohort Study.
The aim of the study is to test the hypothesis that oral taking of baclofen in therapeutic dosage for 60 days is equally effective as injection of botulinum toxin type "A" in the area of trigger points of the pelvic muscles.
Read the detailed description
Chronic pelvic pain syndrome (CPPS) is an extremely common disease. The exact epidemiology and socio-economic impact cannot be determined due to its heterogeneity. Thus, according to population studies, CPPS can occur in 12.4% of women aged 18-50 years [1]. In turn, myofascial pelvic pain syndrome (MPPS) is often an underappreciated and untreated component of CPPS that occurs in at least 23% of patients and causes their complaints [2]. In men diagnosed with chronic prostatitis, in 92% of cases, complaints are caused by muscle spasm and pain in muscle structures, mistakenly interpreted by the patient as prostate pain [3]. Often, myofascial syndrome is idiopathic and is associated with problems in the musculoskeletal system. However, in some cases, the primary source is a urological, gynecological or proctological disease. The syndrome is characterized by the appearance of trigger points (TP) - "nodules" in the thickness of striated muscles, which cause distinct local soreness during palpation [4].
Treatment of this condition is complex: it includes training in relaxation of the pelvic muscles using a biofeedback therapy [5], myofascial release [6] and drug therapy. One of the drugs actively used in neurology is baclofen [7]. This drug reduces the spasticity of striated muscles. Despite the widespread using of baclofen in the treatment of neurological conditions accompanied by increased muscle tone, there are no qualitative studies evaluating its effectiveness in chronic pelvic pain syndrome.
If conservative therapy is ineffective, injections of botulinum toxin type "A" (BTA) into TP on pelvic floor muscles are the method of choice [8]. This method is a third-line treatment: thus, according to the meta-analysis of Fang Yuan Luo et al., which includes 5 RCTs and 12 observational studies, there is not enough convincing data for using BTA as the first line of treatment [9]. At the same time, there are a number of studies in which the effect of the introduction of BTA was comparable to the introduction of local anesthetics [10] and saline solution [11].
Thus, despite the inconsistency of the methods, a comparative study of the efficacy and safety of these drugs, as well as the quality of life of patients after treatment, is of interest.
- Conditions
- Chronic Pain, Chronic Pelvic Pain Syndrome, Myofascial Pain Syndrome, Myofascial Trigger Point Pain, Pelvic Floor Disorders
- Being tested
- Baclofen 10mg, Botulinum toxin type A
- Medical subject headings
- Chronic Pain, Myofascial Pain Syndromes, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baclofen 10mgDrug
Also called Baclosan
Baclofen is a medication, a central myorelaxant, a GABAb stimulator.
Also called Botox, Xeomin, Dysport
Botulinum toxin, often shortened to BoNT, is a neurotoxic protein produced by the bacterium Clostridium botulinum and related species.
| Study group | Role | What they receive |
|---|---|---|
| Baclofen | A cohort of patients who have not previously received baclofen will be offered a course of the drug therapy at a dosage of 10 mg according to the scheme:
1-3 days - 1 tablet per day; 4-6 days - 2 tablets per day; 7-9 days - 3 tablets per day; 10 days and then 4 tablets per day (morning and evening). Receives: Drug: Baclofen 10mg | |
| BTA | A cohort of patients who previously received baclofen and canceled the course due to the development of side effects and/or individual intolerance, or who have contraindications to the use of this drug, will receive several injections with a total volume of 100 units. botulinum toxin type "A" in dilution up to 20 ml, distributed at the trigger points of the pelvic floor muscles. Receives: Drug: Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
PGI-I
Patients Global Impression of Improvement (PGI-I). The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1. Very much better to 7. Very much worse.
Measured: 60 days
Secondary outcomes (4)
VAS
Visual Analogue Scale (VAS). The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best). The line is divided into 10 sections. 1 section = 1 point. The more points, the more pronounced the pain syndrome - the worse outcome
Measured: 14, 30, 60 days
The Lamont Scale
The Lamont scale was developed to aide in the diagnosis of vaginismus. The five degrees of severity are defined. The more points, the more pronounced the patient's reaction to the examination in the gynecological chair. Points from 1 to 5. The The higher the score, the more pronounced the vaginismus and fear of examination. Minimum score = 0. Maximum score = 5. The lower score, the better outcome
Measured: 14, 30, 60 days
IPSS/QoL
International Prostate Symptom Score (IPSS). The IPSS questionnaire evaluates the impact of lower urinary tract symptoms on the patient's quality of life. It consists of 8 questions. Questionts evaluates whether the patient has symptoms of incomplete emptying of the bladder and ranges from 0 to 5 points. The increase in scores is directly proportional to the increase in symptoms. Minimum score = 0. Maximum score = 41. The lower score, the better outcome
Measured: 14, 30, 60 days
Clavien-Dindo Complication rate
The development of complications from therapy that require its termination
Measured: 14, 30, 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start1 Dec 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Petersburg State University, Russia
- Sponsor type
- University, hospital or other
- Collaborators
- Ural State Medical University
- Responsible party
- Principal investigator, Gleb Kovalev, Saint Petersburg State University, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617118
- Sponsor's protocol ID
- 22/30 301
- Acronym
- BvsB
- Status last verified
- Apr 2023
- First submitted
- 7 Nov 2022
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Zondervan K, Barlow DH. Epidemiology of chronic pelvic pain. Baillieres Best Pract Res Clin Obstet Gynaecol. 2000 Jun;14(3):403-14. doi: 10.1053/beog.1999.0083.
PubMed 10962634Tu FF, As-Sanie S, Steege JF. Prevalence of pelvic musculoskeletal disorders in a female chronic pelvic pain clinic. J Reprod Med. 2006 Mar;51(3):185-9.
PubMed 16674013Zermann D, Ishigooka M, Doggweiler R, Schmidt R. Chronic prostatitis: A myofascial pain syndrome? Infections in Urology 1999;12:84-92
Jha S, Toozs-Hobson P, Roper JC, Gurung S, Brair A, Bach F. Botulinum injections for myofascial pelvic pain. Int Urogynecol J. 2021 May;32(5):1151-1156. doi: 10.1007/s00192-020-04435-w. Epub 2020 Jul 21.
PubMed 32696187Hite M, Curran T. Biofeedback for Pelvic Floor Disorders. Clin Colon Rectal Surg. 2021 Jan;34(1):56-61. doi: 10.1055/s-0040-1714287. Epub 2020 Sep 4.
PubMed 33536850Peñas CF de las, Campo MS, Carnero JF, Page JCM. Manual therapies in myofascial trigger point treatment: A systematic review. Journal of Bodywork and Movement Therapies 2005;9:27-34. doi:10.1016/j.jbmt.2003.11.001.
Chang WJ. Muscle Relaxants for Acute and Chronic Pain. Phys Med Rehabil Clin N Am. 2020 May;31(2):245-254. doi: 10.1016/j.pmr.2020.01.005. Epub 2020 Mar 13.
PubMed 32279727Morrissey D, El-Khawand D, Ginzburg N, Wehbe S, O'Hare P 3rd, Whitmore K. Botulinum Toxin A Injections Into Pelvic Floor Muscles Under Electromyographic Guidance for Women With Refractory High-Tone Pelvic Floor Dysfunction: A 6-Month Prospective Pilot Study. Female Pelvic Med Reconstr Surg. 2015 Sep-Oct;21(5):277-82. doi: 10.1097/SPV.0000000000000177.
PubMed 25900057Luo FY, Nasr-Esfahani M, Jarrell J, Robert M. Botulinum toxin injection for chronic pelvic pain: A systematic review. Acta Obstet Gynecol Scand. 2020 Dec;99(12):1595-1602. doi: 10.1111/aogs.13946. Epub 2020 Jul 16.
PubMed 32597494Levesque A, Ploteau S, Michel F, Siproudhis L, Bautrant E, Eggermont J, Rabischong B, Volteau C, Perrouin-Verbe MA, Labat JJ. Botulinum toxin infiltrations versus local anaesthetic infiltrations in pelvic floor myofascial pain: Multicentre, randomized, double-blind study. Ann Phys Rehabil Med. 2021 Jan;64(1):101354. doi: 10.1016/j.rehab.2019.12.009. Epub 2020 Jan 22.
PubMed 31981833Parsons BA, Goonewardene S, Dabestani S, Pacheco-Figueiredo L, Yuan Y, Zumstein V, Cottrell AM, Borovicka J, Dinis-Oliveira P, Berghmans B, Elneil S, Hughes J, Messelink BEJ, de C Williams AC, Baranowski AP, Engeler DS. The Benefits and Harms of Botulinum Toxin-A in the Treatment of Chronic Pelvic Pain Syndromes: A Systematic Review by the European Association of Urology Chronic Pelvic Pain Panel. Eur Urol Focus. 2022 Jan;8(1):320-338. doi: 10.1016/j.euf.2021.01.005. Epub 2021 Jan 30.
PubMed 33526405Cook D, Lauzier F, Rocha MG, Sayles MJ, Finfer S. Serious adverse events in academic critical care research. CMAJ. 2008 Apr 22;178(9):1181-4. doi: 10.1503/cmaj.071366. No abstract available.
PubMed 18427095
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Oral Baclofen Taking in Comparison With Botulinum Toxin A Injections in Myofascial Pelvic Pain Syndrome. Prospective Multicenter Cohort Study.
- ClinicalTrials.gov ID
- NCT05617118
- Acronym / sponsor ID
- BvsB / 22/30 301
- Conditions
- Chronic Pain, Chronic Pelvic Pain Syndrome, Myofascial Pain Syndrome, Myofascial Trigger Point Pain, Pelvic Floor Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Saint Petersburg State University, RussiaUniversity, hospital or other
- Collaborators
- Ural State Medical University
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 15 Nov 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.
The aim of the study is to test the hypothesis that oral taking of baclofen in therapeutic dosage for 60 days is equally effective as injection of botulinum toxin type "A" in the area of trigger points of the pelvic muscles.
Detailed description
Chronic pelvic pain syndrome (CPPS) is an extremely common disease. The exact epidemiology and socio-economic impact cannot be determined due to its heterogeneity. Thus, according to population studies, CPPS can occur in 12.4% of women aged 18-50 years [1]. In turn, myofascial pelvic pain syndrome (MPPS) is often an underappreciated and untreated component of CPPS that occurs in at least 23% of patients and causes their complaints [2]. In men diagnosed with chronic prostatitis, in 92% of cases, complaints are caused by muscle spasm and pain in muscle structures, mistakenly interpreted by the patient as prostate pain [3]. Often, myofascial syndrome is idiopathic and is associated with problems in the musculoskeletal system. However, in some cases, the primary source is a urological, gynecological or proctological disease. The syndrome is characterized by the appearance of trigger points (TP) - "nodules" in the thickness of striated muscles, which cause distinct local soreness during palpation [4].
Treatment of this condition is complex: it includes training in relaxation of the pelvic muscles using a biofeedback therapy [5], myofascial release [6] and drug therapy. One of the drugs actively used in neurology is baclofen [7]. This drug reduces the spasticity of striated muscles. Despite the widespread using of baclofen in the treatment of neurological conditions accompanied by increased muscle tone, there are no qualitative studies evaluating its effectiveness in chronic pelvic pain syndrome.
If conservative therapy is ineffective, injections of botulinum toxin type "A" (BTA) into TP on pelvic floor muscles are the method of choice [8]. This method is a third-line treatment: thus, according to the meta-analysis of Fang Yuan Luo et al., which includes 5 RCTs and 12 observational studies, there is not enough convincing data for using BTA as the first line of treatment [9]. At the same time, there are a number of studies in which the effect of the introduction of BTA was comparable to the introduction of local anesthetics [10] and saline solution [11].
Thus, despite the inconsistency of the methods, a comparative study of the efficacy and safety of these drugs, as well as the quality of life of patients after treatment, is of interest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baclofen | – | Drug: Baclofen 10mgA cohort of patients who have not previously received baclofen will be offered a course of the drug therapy at a dosage of 10 mg according to the scheme: 1-3 days - 1 tablet per day; 4-6 days - 2 tablets per day; 7-9 days - 3 tablets per day; 10 days and then 4 tablets per day (morning and evening). |
| BTA | – | Drug: Botulinum toxin type AA cohort of patients who previously received baclofen and canceled the course due to the development of side effects and/or individual intolerance, or who have contraindications to the use of this drug, will receive several injections with a total volume of 100 units. botulinum toxin type "A" in dilution up to 20 ml, distributed at the trigger points of the pelvic floor muscles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with long-term chronic pelvic pain syndrome who have not previously received targeted treatment for myofascial pelvic pain syndrome
Key inclusion criteria (2 listed)
- Myofascial pain syndrome (presence of trigger points), confirmed by palpation during examination.
- Ineffectiveness (with subsequent discontinuation) of at least one treatment method, including outpatient physiotherapy and /or oral analgesics, or NSAIDs.
Key exclusion criteria (4 listed)
- The presence of any organic disease of the pelvic organs requiring active treatment, confirmed by anamnesis, consultation of a specialist (urologist, proctologist, gynecologist) and one of the objective imaging methods: CT, MRI, endoscopical or laboratory methods: general urine analysis or prostate secretion analysis. Such diseases include interstitial cystitis / SBMP, chronic prostatitis types I, II, IIIA according to the NIH classification.
- The presence in the anamnesis of the fact of previously conducted therapy with baclofen or injection of botulinum toxin type "A" into the pelvic floor muscles.
- Individual intolerance to botulinum toxin type "A" and /or baclofen.
- Pregnancy
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 |
|---|---|---|
| Baclofen 10mgAlso: BaclosanBaclofen is a medication, a central myorelaxant, a GABAb stimulator. | Drug | Baclofen |
| Botulinum toxin type AAlso: Botox, Xeomin, DysportBotulinum toxin, often shortened to BoNT, is a neurotoxic protein produced by the bacterium Clostridium botulinum and related species. | Drug | BTA |
Primary outcome
PGI-I
Time frame: 60 days
Patients Global Impression of Improvement (PGI-I). The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1. Very much better to 7. Very much worse.
4 secondary outcomes
VAS
Time frame: 14, 30, 60 days
The Lamont Scale
Time frame: 14, 30, 60 days
IPSS/QoL
Time frame: 14, 30, 60 days
Clavien-Dindo Complication rate
Time frame: 14, 30, 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Background: PubMed 10962634Zondervan K, Barlow DH. Epidemiology of chronic pelvic pain. Baillieres Best Pract Res Clin Obstet Gynaecol. 2000 Jun;14(3):403-14. doi: 10.1053/beog.1999.0083.
- Background: PubMed 16674013Tu FF, As-Sanie S, Steege JF. Prevalence of pelvic musculoskeletal disorders in a female chronic pelvic pain clinic. J Reprod Med. 2006 Mar;51(3):185-9.
- BackgroundZermann D, Ishigooka M, Doggweiler R, Schmidt R. Chronic prostatitis: A myofascial pain syndrome? Infections in Urology 1999;12:84-92
- Background: PubMed 32696187Jha S, Toozs-Hobson P, Roper JC, Gurung S, Brair A, Bach F. Botulinum injections for myofascial pelvic pain. Int Urogynecol J. 2021 May;32(5):1151-1156. doi: 10.1007/s00192-020-04435-w. Epub 2020 Jul 21.
- Background: PubMed 33536850Hite M, Curran T. Biofeedback for Pelvic Floor Disorders. Clin Colon Rectal Surg. 2021 Jan;34(1):56-61. doi: 10.1055/s-0040-1714287. Epub 2020 Sep 4.
- BackgroundPeñas CF de las, Campo MS, Carnero JF, Page JCM. Manual therapies in myofascial trigger point treatment: A systematic review. Journal of Bodywork and Movement Therapies 2005;9:27-34. doi:10.1016/j.jbmt.2003.11.001.
- Background: PubMed 32279727Chang WJ. Muscle Relaxants for Acute and Chronic Pain. Phys Med Rehabil Clin N Am. 2020 May;31(2):245-254. doi: 10.1016/j.pmr.2020.01.005. Epub 2020 Mar 13.
- Background: PubMed 25900057Morrissey D, El-Khawand D, Ginzburg N, Wehbe S, O'Hare P 3rd, Whitmore K. Botulinum Toxin A Injections Into Pelvic Floor Muscles Under Electromyographic Guidance for Women With Refractory High-Tone Pelvic Floor Dysfunction: A 6-Month Prospective Pilot Study. Female Pelvic Med Reconstr Surg. 2015 Sep-Oct;21(5):277-82. doi: 10.1097/SPV.0000000000000177.
- Background: PubMed 32597494Luo FY, Nasr-Esfahani M, Jarrell J, Robert M. Botulinum toxin injection for chronic pelvic pain: A systematic review. Acta Obstet Gynecol Scand. 2020 Dec;99(12):1595-1602. doi: 10.1111/aogs.13946. Epub 2020 Jul 16.
- Background: PubMed 31981833Levesque A, Ploteau S, Michel F, Siproudhis L, Bautrant E, Eggermont J, Rabischong B, Volteau C, Perrouin-Verbe MA, Labat JJ. Botulinum toxin infiltrations versus local anaesthetic infiltrations in pelvic floor myofascial pain: Multicentre, randomized, double-blind study. Ann Phys Rehabil Med. 2021 Jan;64(1):101354. doi: 10.1016/j.rehab.2019.12.009. Epub 2020 Jan 22.
- Background: PubMed 33526405Parsons BA, Goonewardene S, Dabestani S, Pacheco-Figueiredo L, Yuan Y, Zumstein V, Cottrell AM, Borovicka J, Dinis-Oliveira P, Berghmans B, Elneil S, Hughes J, Messelink BEJ, de C Williams AC, Baranowski AP, Engeler DS. The Benefits and Harms of Botulinum Toxin-A in the Treatment of Chronic Pelvic Pain Syndromes: A Systematic Review by the European Association of Urology Chronic Pelvic Pain Panel. Eur Urol Focus. 2022 Jan;8(1):320-338. doi: 10.1016/j.euf.2021.01.005. Epub 2021 Jan 30.
- Background: PubMed 18427095Cook D, Lauzier F, Rocha MG, Sayles MJ, Finfer S. Serious adverse events in academic critical care research. CMAJ. 2008 Apr 22;178(9):1181-4. doi: 10.1503/cmaj.071366. No abstract available.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Chronic Pelvic Pain Syndrome, run by Saint Petersburg State University, Russia at 1 site in Russia.
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 2 inclusion and 4 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 11 Apr 2023. 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gleb Kovalev, MD, PhD (+7(911)199-72-75, kovalev2207@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PGI-I (time frame: 60 days). 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 NCT05617118, which also lists 12 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 11 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.