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SpasticityPhase 1/2LANTIMANCT04752774

A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.

A Phase 1/2 study testing Corabotase and Dysport in people with Spasticity, run by Ipsen at 81 sites in 14 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of the study is to assess the safety and efficacy of increasing doses of Corabotase (also known as IPN10200) with the aim to evaluate the Pharmacodynamics (PD) profile of Corabotase and to establish the total Corabotase doses(s) that offer the best efficacy/safety profile when used for the treatment of… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Spasticity
What is being tested?
Corabotase and Dysport
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
81 sitesin 14 countries
Study dates
29 Apr 2021to 30 Mar 2029
Phase
Phase 1/2
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must be 18 to 70 years of age inclusive (except for dose escalation must be 18 to 65 years of age) at the time of signing the informed consent.
  • Has spastic hemiparesis following stroke or Traumatic brain injury (TBI)
  • Is at least 6 months post-stroke or TBI
  • Has never received BoNT or if previously treated, should have received their last injection of any commercialized BoNT-A or B at least 4 months prior to study Baseline
  • Has a MAS score ≥2 in the (PTMG) to be injected
  • Is eligible to receive a total recommended dose 1000 U Dysport in the upper limb when applicable.
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  • Has angle of spasticity ≥5° in the PTMG to be injected.
  • Does not have any fixed contractures as defined by:
  • Complete fingers extension with Angle of arrest at slow speed (Tardieu Scale) (XV1) ≥160°
  • Complete wrist extension with XV1 ≥90°
  • Complete elbow extension with XV1 ≥160°
  • Physiotherapy, occupational therapy, splinting, use of benzodiazepine, and muscle relaxants had to be stable from at least 30 days preceding the study Baseline up to the Month 3 visit, and whenever possible until the end of the study.
  • In good health (i.e. absence of any uncontrolled systemic disease or other significant medical condition) as determined by medical history, physical and neurological examinations, clinical laboratory studies, electrocardiograms (ECGs), vital signs, and Investigator's judgment prior to randomization
  • Male and female participants Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Male participants must agree that, if their partner is at risk of becoming pregnant, they will use an effective method of contraception. The participants must agree to use the contraception during the whole period of the study.
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: Is a woman of non-childbearing potential (WONCBP) or is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method (until the end of the study). The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive pregnancy test.

Who cannot join

  • Any medical condition (including severe dysphagia or airway disease) that may increase, in the opinion of the investigator, the likelihood of adverse events (AEs) related to BoNT treatment.
  • Known disease of the neuromuscular junction (e.g. Lambert-Eaton myasthenic syndrome, myasthenia gravis or amyotrophic lateral sclerosis etc.).
  • Has a history of hypersensitivity to the investigational medicinal products (or other BoNTs) or any excipient used in their formulation.
  • Clinically diagnosed significant anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that might interfere with the participant's participation in the study.
  • Likely treatment with any serotype of BoNT for any condition during the study.
  • Undergone previous surgery to treat spasticity in the affected upper limb.
Show all 19Show fewer
  • Has initiated physiotherapy within 30 days prior to Baseline (if physiotherapy initiated more than 30 days prior to Baseline and ongoing, the therapy regimen should be maintained at the same frequency and intensity throughout the study if possible or at least up to 3-months post-injection).
  • Has received previous treatment with phenol and or alcohol in the targeted upper limb any time before the study.
  • Has been treated or is likely to be treated with intrathecal baclofen during the 30 days prior to study Baseline or during the course of the study.
  • Current or planned treatment with any medications that interfere either directly or indirectly with neuromuscular transmission, such as curare-like non depolarising agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics, within 30 days prior to Baseline.
  • Use of concomitant therapy which, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study intervention, including medications affecting bleeding disorders. For patients taking vitamin K antagonists, the INR values should be controlled (between 2 and 3)
  • Currently planned or a history of tendon lengthening surgery, significant contracture or muscle atrophy at target joint or muscle in the past 6 months prior to Screening.
  • Use of any experimental device within 30 days or use of any treatment with an experimental drug within five times the documented terminal half-life of the respective drug or its metabolites or if the half-life is unknown within 30 days prior to the start of the study (prior to Baseline) and during the conduct of the study.
  • Presence of any other condition (e.g. neuromuscular disorder, muscular dystrophies, cancer cachexia, sarcopenia or other disorder that could interfere with neuromuscular function), laboratory finding or circumstance that, in the judgment of the investigator, might increase the risk to the participant or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
  • Pregnant or lactating women, or women of childbearing potential not willing to practice a highly effective form of contraception method at the beginning of the study, for the duration of the study and for the duration of the study
  • Inability to understand protocol procedures and requirements
  • Infection at the injection site(s)
  • A history of drug or alcohol abuse
  • Male participants who are not vasectomised and who have female partners of childbearing potential and are not willing to use condoms with spermicide throughout study participation.

Trial locations and contacts

81 sites in 14 countries. Contact the study team or a site near you to ask about taking part.

Ipsen Recruitment Enquiries contact

see email

clinical.trials@ipsen.com

81 sites in 14 countries

Poland15 sites, 9 recruiting

  • St Wojciech - Adalbertus Hospital, Neurology Department

    Gdansk, 80-462

    Recruiting

  • Specialist Doctor Practice

    Katowice, 40-097

    Terminated

  • Ma-Lek MS Therapy Centre

    Katowice, 40-571

    Withdrawn

  • Neuro-Medic

    Katowice, 40-686

    Recruiting

  • Specialist Practises LLC

    Krakow, 30-539

    Recruiting

  • Linden Medical Center

    Krakow, 30-721

    Specialist P LLC

    Recruiting

  • Clinical Center for Neurology Sp. z o .o. (LLC)

    Krakow, 31-505

    Specialist P LLC

    Recruiting

  • NeuroKlinika - Private Practice Prof. Andrzej Bogucki

    Lodz, 90-640

    Withdrawn

  • Health Institute Dr n. med. Magdalena Boczarska-Jedynak

    Oświęcim, 32-600

    Recruiting

  • Clinical Research Center SP. ZOO MEDIC-R

    Poznan, 61-731

    Terminated

  • Neuro-Kard Ilkowski and Partners

    Poznan, 61-853

    Recruiting

  • Holy Spirit Specialist Hospital in Sandomierz - Neurology Teaching Hospital, Neurology Department

    Sandomierz, 27-600

    Recruiting

  • Wolski Hospital, Neurological Department

    Warsaw, 01-211

    Withdrawn

  • NeuroProtect Medical Center

    Warsaw, 01-684

    Withdrawn

  • EuroMediCare Specialist Outpatient Clinics in Wroclaw

    Wroclaw, 50-220

    Recruiting

Other trials in Poland

Germany8 sites, 4 recruiting

  • University Hospital Bonn, Clinic and Policlinic for Neurology

    Bonn, 53127

    Recruiting

  • Heinrich Heine University Medical Center, Department of Neurology

    Düsseldorf, 40225

    Terminated

  • University Medicine Goettingen, Department of Neurology

    Goettigen, 37075

    Withdrawn

  • University Hospital Hamburg-Eppendorf, Clinic and Polyclinic of Neurology

    Hamburg, 20246

    Recruiting

  • University Hospital Johannes Gutenberg - University of Mainz, Clinic and Polyclinic of Neurology

    Mainz, 55131

    Terminated

  • Ludwig Maximilians University Hospital, Campus Grosshadern, Department of Neurology

    Munich, 81377

    Withdrawn

  • GFO Clinics Troisdorf, St. Johannes Sieglar

    Troisdorf, 53844

    Recruiting

  • University Hospital Tuebingen, Department of Neurology

    Tübingen, 72076

    Recruiting

Other trials in Germany

Spain7 sites, 7 recruiting

  • Hospital Maritimo de Oza

    A Coruña, 15006

    Recruiting

  • University Hospital Vall d'Hebron

    Barcelona, 08035

    Recruiting

  • Juan Ramon Jimenez Hospital

    Huelva, 21005

    Recruiting

  • University Hospital de La Princesa, Physical Medicine and Rehabilitation

    Madrid, 28006

    Recruiting

  • Santiago de Compostela Clinical Hospital, Physical Medicine and Rehabilitation

    Santiago de Compostela, 15706

    Recruiting

  • University Hospital Virgen Macarena, Physical Medicine and Rehabilitation

    Seville, 41009

    Recruiting

  • Meixoeiro Hospital at Vigo University Hospital Complex

    Vigo, 36200

    Recruiting

Other trials in Spain

Czechia6 sites, 4 recruiting

  • University Hospital Hradec Kralove, Clinic of Neurology

    Hradec Králové, 500 05

    Withdrawn

  • Hospital Jihlava, Department of Neurology

    Jihlava, 586 33

    Recruiting

  • University Hospital Ostrava, Clinic of Neurology, Center for Demyelinating diseases

    Ostrava, 708 52

    Recruiting

  • Regional Hospital Pardubice, Clinic of Neurology

    Pardubice, 532 03

    Recruiting

  • University Hospital Kralovske Vinohrady, Clinic of Neurology

    Prague, 100 34

    Withdrawn

  • General University Hospital in Prague, Clinic of Neurology

    Prague, 120 00

    Recruiting

Other trials in Czechia

Russia6 sites

  • Federal Siberian Research and Clinical Center, Department of Nervous Diseases, Traditional Medicine with Course in Postgraduate Education

    Krasnoyarsk, 660049

    Withdrawn

  • National Medical Research Center Treatment and Rehabilitation Center, Department of Neurology

    Moscow, 125367

    Withdrawn

  • "Praximed" - Diagnostic and Rehabilitation Center, Rehalibitation Department

    Saint Petersburg, 194223

    Withdrawn

  • N.P. Bekhtereva Research Institute of Human Brain

    Saint Petersburg, 197376

    Withdrawn

  • Astarta, LLC, Department of Neurology

    Saint Petersburg, 199226

    Withdrawn

  • Medical and Sanitary Unit #70 of "Passazhiravtotrans"

    Saint Petersburg

    Withdrawn

Other trials in Russia

United States5 sites, 4 recruiting

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Recruiting

  • Rancho Los Amigos National Rehab

    Downey, California, 90242

    Recruiting

  • Einstein Physical Medicine and Rehabilitation at Elkins Park

    Elkins Park, Pennsylvania, 19027

    Recruiting

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

    Terminated

  • Kansas Institute of Research

    Overland Park, Kansas, 66211

    Recruiting

Other trials in United States

Bulgaria5 sites, 4 recruiting

  • Multiprofile Hospital for Active Treatment "Heart and Brain"

    Pleven, 5800

    Withdrawn

  • Medical Center "Rusemed" EOOD

    Rousse, 7005

    Recruiting

  • Multiprofile Hospital for Active Treatment of Neurology and Psychiatry "Sveti Naum", Sofia, Neurological Diseases Clinic for Neurodegenerative and Peripheral Neurological Diseases

    Sofia, 1113

    Recruiting

  • Diagnostic Consulting Center - Convex EOOD

    Sofia, 1680

    Recruiting

  • Medical Center Medica Plus Ltd

    Veliko Tarnovo, 5006

    Recruiting

Other trials in Bulgaria

Hungary5 sites, 5 recruiting

  • Semmelweis University, Rehabilitation Clinic, Rehabilitation Department of Brain Injuries

    Budapest

    Recruiting

  • University of Debrecen Clinical Center, Department of Medical Rehabilitation and Physical Medicine

    Debrecen, H-4031

    Recruiting

  • Petz Aladar University Teaching Hospital, Department of Neurology

    Győr

    Recruiting

  • Szent Damjan Greek Catholic Hospital, Department of Neurology and Stroke

    Kisvárda, H-4600

    Recruiting

  • Borsod-Abauj-Zemplen County Central Hospital and University Educational Hospital, Department of Neurology

    Miskolc

    Recruiting

Other trials in Hungary

Austria4 sites, 3 recruiting

  • Medical University Innsbruck, Department of Neurology

    Innsbruck, 6020

    Recruiting

  • Kepler University Hospital GmbH, Department of Neurology and Psychiatry

    Linz, 4021

    Recruiting

  • Brothers of Charity Hospital Linz, Department of Neurology I

    Linz, A-4021

    Recruiting

  • Medical University Vienna, Department of Neurology

    Vienna, 1090

    Withdrawn

Other trials in Austria

France4 sites, 4 recruiting

  • Bastia Hospital Center

    Bastia, 20600

    Not yet recruiting

  • Bordeaux University Hospital Center - Pellegrin Hospital Group

    Bordeaux, 33076

    Not yet recruiting

  • Brest University Hospital Center - Morvan Hospital

    Brest, 29200

    Not yet recruiting

  • Raymond-Poincare Hospital - APHP

    Garches, 92380

    Not yet recruiting

Other trials in France

Italy4 sites, 4 recruiting

  • ASST Spedali Civili Brescia

    Brescia, 25123

    Recruiting

  • University Hospital "Federico II"

    Naples, 80131

    Not yet recruiting

  • University Polyclinic Foundation "Agostino Gemelli" - IRCCS

    Rome, 00168

    Not yet recruiting

  • Clinical Research Center of Verona S.r.l. - CRC

    Verona, 37134

    Recruiting

Other trials in Italy

Japan4 sites, 4 recruiting

  • Fukuoka Rehabilitation Hospital

    Fukuoka

    Recruiting

  • Chutoen General Medical Center, Department of Rehabilitation

    Shizuoka

    Recruiting

  • Tokushima University Hospital

    Tokushima, 770-8503

    Recruiting

  • NHO Murayama Medical Center, Department of Rehabilitation

    Tokyo

    Recruiting

Other trials in Japan

Portugal4 sites, 4 recruiting

  • Alto Ave Central Hospital

    Guimarães, 4835-044

    Recruiting

  • Local Health Unit Loures-Odivelas E.P.E.

    Loures, 2674-514

    Recruiting

  • Local Health Unit of Matosinhos (ULSM), EPE - Pedro Hispano Hospital

    Matosinhos Municipality, 4464-513

    Recruiting

  • Local Unit of Health in Alto Minho, EPE

    Viana do Castelo, 4904-858

    Recruiting

Other trials in Portugal

South Korea4 sites, 4 recruiting

  • Dongguk University Ilsan Hospital

    Goyang-si, 10326

    Recruiting

  • The Catholic University of Korea - Incheon St. Mary's Hospital

    Incheon, 21431

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Recruiting

Other trials in South Korea

About this study

Official title: An Integrated Phase I/II, Multicentre, Double-blind, Randomised, Dysport and Placebo-controlled, Dose Escalation and Dose-finding Study to Evaluate the Safety and Efficacy of IPN10200 in the Treatment of Adult Upper Limb Spasticity.

The purpose of the study is to assess the safety and efficacy of increasing doses of Corabotase (also known as IPN10200) with the aim to evaluate the Pharmacodynamics (PD) profile of Corabotase and to establish the total Corabotase doses(s) that offer the best efficacy/safety profile when used for the treatment of Adult upper limb (AUL) spasticity.

Conditions
Spasticity
Being tested
Corabotase, Placebo, Dysport
Keywords
Upper limb spasticity after stroke or traumatic brain injury
Medical subject headings
Muscle Spasticity, Brain Injuries, Traumatic

What participants receive

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

  • CorabotaseBiological

    Also called IPN10200

    Powder and solvent for solution for injection

  • PlaceboDrug

    Powder and solvent for solution for injection

  • DysportBiological

    Powder for solution for injection

Study groups in NCT04752774
Study groupRoleWhat they receive
Dose escalationExperimentalOne single administration of study medication (Corabotase, Dysport or placebo) will be injected in a dose-escalation manner. Dose-escalation will include several cohorts.
Receives: Biological: Corabotase; Drug: Placebo; Biological: Dysport
Dose rangingExperimentalTwo fixed doses of Corabotase will be administrated as a single injection into several muscle groups of the upper limb. Participants will be randomised in the ratio of 3:3:2 (total Corabotase dose 1: 30 participants; total Corabotase dose 2: 30 participants; Dysport: 20 participants)
Receives: Biological: Corabotase; Biological: Dysport
Total doseExperimentalOne single injection of study medication will be administered locally into several muscle groups of the upper limb. Participants will be randomized in the ratio of 2:1 (Total Corabotase dose: 30 participants; placebo: 15 participants, resulting in a total of 45 participants in Stage 3). Or Participants will be randomized in the ratio of 3:1 (Corabotase lower dose: 30 participants; placebo: 10 participants, then Corabotase higher dose: 30 participants; placebo: 10 participants, resulting in a total of 80 participants in Stage 3).
Receives: Biological: Corabotase; Drug: Placebo

What is being measured

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

  1. Percentage of participants with treatment emergent adverse events (TEAEs).

    An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: From baseline until the end of study (9 months)

  2. Percentage of participants with adverse events of special interest (AESI).

    Measured: From baseline until the end of study (9 months)

  3. Change from baseline in vital sign parameter (blood pressure)

    Measured: 9 months

  4. Change from baseline in vital sign parameter (Heart rate)

    Measured: 9 months

  5. Change from baseline in clinical laboratory test results.

    Number and percentage of participants with low, normal or high values and normal or abnormal examinations will be presented.

    Measured: 9 months

  6. Presence of IPN10200 and BoNT-A antibodies (binding and neutralising)

    Measured: From baseline until the end of study (9 months)

  7. Change from baseline in physical examination findings.

    Number of Participants with change in physical examination findings

    Measured: 9 months

Secondary outcomes (14)

  1. Change from Baseline to all post-treatment visits in Modified Ashworth scale (MAS) score in the Primary target muscle group (PTMG)

    MAS is a scale to assess muscle tone in the injected muscles. The muscle tone will be rated as per grading from 0 to 4, there 0 =No increase in muscle tone and 4 =Affected part(s) rigid in flexion or extension.

    Measured: from baseline until the end of study (9 months)

  2. Change from Baseline to post-treatment Day 29 in MAS score in the PTMG.

    If PD profile of IPN10200 in dose escalation indicates a peak of effect different than Day 29, the endpoint will be modified accordingly)

    Measured: From baseline until post-treatment Day 29

  3. Change from Baseline in MAS score in all injected muscle Groups

    Measured: From baseline until the end of study (9 months)

  4. Time to onset - time to the response to treatment (a reduction of at least one grade in the MAS score).

    Measured: From baseline until the end of study (9 months)

  5. Peak of effect - maximal decrease in the MAS score from Baseline.

    Measured: From baseline until the end of study (9 months)

  6. Time to peak - time to reach the peak of effect (maximal decrease in the MAS score from Baseline).

    Measured: From baseline until the end of study (9 months)

  7. Duration of effect - duration between time to onset and last timepoint with a response to Treatment.

    Measured: From baseline until the end of study (9 months)

  8. Response to treatment as measured by at least one grade reduction in MAS score in the PTMG from Baseline

    Measured: From baseline until the end of study (9 months)

  9. Response to treatment as measured by at least one grade reduction in MAS score in all injected muscles from Baseline

    Measured: From baseline until the end of study (9 months)

  10. Physician's Global Assessment (PGA) score of overall treatment response

    The PGA is a 9-point scale (from -4= markedly worse to +4=markedly improved) used to assess global overall treatment response by the investigator.

    Measured: From baseline until the end of study (9 months)

  11. Patient Global Impression of Change in the Spastic Clinical Pattern using specific scale (PGI-c)

    PGI-C is a scale to assess global impression of change in the spastic clinical pattern using a 7-point Likert scale (from -3: very much worse to +3: very much improved) by answering a specific question

    Measured: from baseline until the end of study (9 months)

  12. Change from Baseline in the Disability Assessment Scale (DAS)

    The DAS will be used to assess the effect of upper limb spasticity on hygiene, dressing, limb position and pain. Participants will be assessed in an interview format.

    Measured: From baseline until the end of study (9 months)

  13. Reduction of pain in the shoulder (adducted/rotated pattern) using the Numeric Rating Scale

    Measured: From baseline until the end of study (9 months)

  14. The number and percentage of participants with presence of IPN10200 and BoNT-A antibodies and titres (binding and neutralising)

    Measured: At baseline

Timeline

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

  1. First posted12 Feb 2021
  2. Study start29 Apr 2021
  3. Primary completion30 Mar 2029 (estimated)
  4. Study completion30 Mar 2029 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04752774
Sponsor's protocol ID
D-FR-10200-001
Other IDs
2020-003623-42
Acronym
LANTIMA
Status last verified
Jul 2026
First submitted
3 Feb 2021
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Corabotase and Dysport in people with Spasticity, run by Ipsen at 81 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 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: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in Poland, Germany, Spain, Czechia, Russia and 9 more countries. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Ipsen Recruitment Enquiries (see email, clinical.trials@ipsen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with treatment emergent adverse events (TEAEs). (time frame: From baseline until the end of study (9 months)). The study lists 7 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 NCT04752774.

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 28 Jul 2026.

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