Carpal Tunnel SyndromePhase 4NCT04025203
Pain Reduction and Changes in Upper Limb Function Produced by Different Treatments in Carpal Tunnel Syndrome
A Phase 4 study testing Median nerve neural mobilization, Ibuprofen Arginine and Gabapentin in people with Carpal Tunnel Syndrome, run by Francisco Unda Solano at 1 site in Venezuela.
Trial summary
In the present investigation the pain reduction effects of a physiotherapy technique will be compared to those produced by two different pharmaceutical treatments and also by the absence of treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Median nerve neural mobilization, Ibuprofen Arginine and Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteVenezuela
- Study dates
- 1 Aug 2019to 30 Nov 2019
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be medically diagnosed with unilateral carpal tunnel syndrome (with confirmative electrodiagnostic findings).
- Full understanding of written and spoken Spanish (language).
- Participants must freely consent to participate.
- The presence of positive Phalen and Tinel sign.
- The presence of carpal tunnel syndrome signs and symptoms
Who cannot join
- The lack to meet inclusion criterions, the presence of cognitive impairment, tumors, cancer, recent (affected) upper limb surgery or trauma, pregnancy, metabolic neuropathy, obesity (body mass index over 30), participants who are not employed, deformities of the (affected) upper limb, recent skin injuries or infections (in the affected upper limb), autoimmune inflammatory conditions or flu type symptoms, allergy to gabapentin, allergy to ibuprofen arginine, and also: participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Reduction and Changes in Upper Limb Function Produced by Physiotherapy, Ibuprofen Arginine, Gabapentin and the Absence of Treatment, in Carpal Tunnel Syndrome
In the present investigation the pain reduction effects of a physiotherapy technique will be compared to those produced by two different pharmaceutical treatments and also by the absence of treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.
Read the detailed description
The present randomized clinical trial will perform a comparison of the pain reduction effects produced by the application of a non invasive and non pharmacological median nerve neural mobilization (physiotherapy treatment), to those effects produced by an oral ibuprofen arginine pharmacological treatment, an oral gabapentin pharmacological treatment and the lack of treatment in subjects diagnosed with carpal tunnel syndrome. Additionally, effects over the functionality of the affected upper limb will be evaluated and compared. Subjects will be invited to participate and randomly allocated to 4 different groups.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Median nerve neural mobilization, Ibuprofen Arginine, Gabapentin
- Keywords
- Ibuprofen Arginine, Gabapentin, Median nerve neural mobilization, Physiotherapy, Pain management
- Medical subject headings
- Carpal Tunnel Syndrome, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Median nerve neural mobilizationOther
Manual therapy maneuver performed in the upper limb.
Ibuprofen ArginineDrug
Also called Spedifen
Oral tablets
GabapentinDrug
Also called Neurontin
oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Median nerve neural mobilization | Experimental | Non pharmaceutical, non invasive, physiotherapy technique; which consists of a passive and repetitive upper limb movement that seeks to induced median nerve gliding and incursions against surrounding connective tissue. Subjects will be treated 5 days per week during a total time lapse of 4 weeks. Receives: Other: Median nerve neural mobilization |
| Ibuprofen arginine | Active comparator | Oral tablet pharmaceutical treatment. Participants will be treated with a maximum of 1200 mg per day, subdivided in 3 intakes of 400 mg each 8 hours during a time lapse of 4 weeks. Receives: Drug: Ibuprofen Arginine |
| Gabapentin | Active comparator | Oral capsule pharmaceutical treatment. Participants will be treated with a maximum of 600 mg per day, subdivided in 2 intakes of 300 mg each 12 hours during a time lapse of 4 weeks. Receives: Drug: Gabapentin |
| Control group | No intervention | Waiting list control group. Participants that belong to the no intervention arm will be assigned to a waiting list to receive treatment. The participants will not receive treatment for carpal tunnel syndrome during a time lapse of 4 weeks. After this period of time, participants will begin the best treatment available. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distal upper limb pain
Assessed through the visual analog scale (VAS). The VAS is a psychometric response scale. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.The VAS is the most frequently used method to assess pain intensity. The scale will be displayed as a horizontal 10-cm line labelled at each end by descriptors such as 'no pain' (the minimum and best outcome possible) and 'worse pain ever' (maximum and worst outcome possible). The participant will mark the line to indicate pain severity and it is simply quantified by measuring the distance in centimeters from 0 (no pain) to the patient's marked rating.
Measured: Changes from baseline (measured immediately before the application of the first treatment) and 40 minutes after the application of the last treatment.
Secondary outcomes (1)
Upper limb function
Assessed through the QuickDASH questionary, which is a shortened version of the 30-item DASH (Disabilities of the Arm, Shoulder and Hand) instrument.The instrument administered to the participants will be a self-report questionnaire, that will rate the difficulty and interference of daily life on a 5 point Likert scale. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability).
Measured: Changes from baseline (measured immediately before the application of the first treatment) at 40 minutes after the application of the last treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start1 Aug 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francisco Unda Solano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francisco Unda Solano, Universidad Europea de Madrid
- Investigators
- Francisco Unda, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025203
- Sponsor's protocol ID
- CE0072015-02-01
- Status last verified
- Dec 2025
- First submitted
- 14 Jul 2019
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ilyas AM, Miller AJ, Graham JG, Matzon JL. A Prospective, Randomized, Double-Blinded Trial Comparing Acetaminophen, Ibuprofen, and Oxycodone for Pain Management After Hand Surgery. Orthopedics. 2019 Mar 1;42(2):110-115. doi: 10.3928/01477447-20190221-02. Epub 2019 Feb 27.
PubMed 30810754Choi GH, Wieland LS, Lee H, Sim H, Lee MS, Shin BC. Acupuncture and related interventions for the treatment of symptoms associated with carpal tunnel syndrome. Cochrane Database Syst Rev. 2018 Dec 2;12(12):CD011215. doi: 10.1002/14651858.CD011215.pub2.
PubMed 30521680Weinheimer K, Michelotti B, Silver J, Taylor K, Payatakes A. A Prospective, Randomized, Double-Blinded Controlled Trial Comparing Ibuprofen and Acetaminophen Versus Hydrocodone and Acetaminophen for Soft Tissue Hand Procedures. J Hand Surg Am. 2019 May;44(5):387-393. doi: 10.1016/j.jhsa.2018.10.014. Epub 2018 Nov 27.
PubMed 30502019Hadianfard M, Bazrafshan E, Momeninejad H, Jahani N. Efficacies of Acupuncture and Anti-inflammatory Treatment for Carpal Tunnel Syndrome. J Acupunct Meridian Stud. 2015 Oct;8(5):229-35. doi: 10.1016/j.jams.2014.11.005. Epub 2014 Nov 29.
PubMed 26433799Giuliani E, Bianchi A, Marcuzzi A, Landi A, Barbieri A. Ibuprofen timing for hand surgery in ambulatory care. Acta Ortop Bras. 2015 Jul-Aug;23(4):188-91. doi: 10.1590/1413-78522015230400736.
PubMed 26327799Riasi H, Rajabpour Sanati A, Salehi F, Salehian H, Ghaemi K. Analyzing the therapeutic effects of short wrist splint in patients with carpal tunnel syndrome (CTS) under ibuprofen treatment from an EMG-NCV perspective. J Med Life. 2015;8(Spec Iss 4):154-158.
PubMed 28316723Davis PT, Hulbert JR, Kassak KM, Meyer JJ. Comparative efficacy of conservative medical and chiropractic treatments for carpal tunnel syndrome: a randomized clinical trail. J Manipulative Physiol Ther. 1998 Jun;21(5):317-26.
PubMed 9627862Banta CA. A prospective, nonrandomized study of iontophoresis, wrist splinting, and antiinflammatory medication in the treatment of early-mild carpal tunnel syndrome. J Occup Med. 1994 Feb;36(2):166-8. doi: 10.1097/00043764-199402000-00012.
PubMed 8176515Hesami O, Haghighatzadeh M, Lima BS, Emadi N, Salehi S. The effectiveness of gabapentin and exercises in the treatment of carpal tunnel syndrome: a randomized clinical trial. J Exerc Rehabil. 2018 Dec 27;14(6):1067-1073. doi: 10.12965/jer.1836420.210. eCollection 2018 Dec.
PubMed 30656171Taverner D, Lisbona MP, Segales N, Docampo E, Calvet J, Castro S, Benito P. [Efficacy of gabapentin in the treatment of carpal tunnel syndrome]. Med Clin (Barc). 2008 Mar 22;130(10):371-3. doi: 10.1157/13117468. Spanish.
PubMed 18381028Dosenovic S, Jelicic Kadic A, Miljanovic M, Biocic M, Boric K, Cavar M, Markovina N, Vucic K, Puljak L. Interventions for Neuropathic Pain: An Overview of Systematic Reviews. Anesth Analg. 2017 Aug;125(2):643-652. doi: 10.1213/ANE.0000000000001998.
PubMed 28731977Erdemoglu AK. The efficacy and safety of gabapentin in carpal tunnel patients: open label trial. Neurol India. 2009 May-Jun;57(3):300-3. doi: 10.4103/0028-3886.53287.
PubMed 19587471Sanz DR, Solano FU, Lopez DL, Corbalan IS, Morales CR, Lobo CC. Effectiveness of median nerve neural mobilization versus oral ibuprofen treatment in subjects who suffer from cervicobrachial pain: a randomized clinical trial. Arch Med Sci. 2018 Jun;14(4):871-879. doi: 10.5114/aoms.2017.70328. Epub 2017 Sep 26.
PubMed 30002707Calvo-Lobo C, Unda-Solano F, Lopez-Lopez D, Sanz-Corbalan I, Romero-Morales C, Palomo-Lopez P, Seco-Calvo J, Rodriguez-Sanz D. Is pharmacologic treatment better than neural mobilization for cervicobrachial pain? A randomized clinical trial. Int J Med Sci. 2018 Mar 8;15(5):456-465. doi: 10.7150/ijms.23525. eCollection 2018.
PubMed 29559834Rodriguez-Sanz D, Lopez-Lopez D, Unda-Solano F, Romero-Morales C, Sanz-Corbalan I, Beltran-Alacreu H, Calvo-Lobo C. Effects of Median Nerve Neural Mobilization in Treating Cervicobrachial Pain: A Randomized Waiting List-Controlled Clinical Trial. Pain Pract. 2018 Apr;18(4):431-442. doi: 10.1111/papr.12614. Epub 2017 Nov 20.
PubMed 28734105
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Reduction and Changes in Upper Limb Function Produced by Physiotherapy, Ibuprofen Arginine, Gabapentin and the Absence of Treatment, in Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT04025203
- Acronym / sponsor ID
- CE0072015-02-01
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Ibuprofen Arginine, Gabapentin, Median nerve neural mobilization, Physiotherapy, Pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Francisco Unda SolanoUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the present investigation the pain reduction effects of a physiotherapy technique will be compared to those produced by two different pharmaceutical treatments and also by the absence of treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.
Detailed description
The present randomized clinical trial will perform a comparison of the pain reduction effects produced by the application of a non invasive and non pharmacological median nerve neural mobilization (physiotherapy treatment), to those effects produced by an oral ibuprofen arginine pharmacological treatment, an oral gabapentin pharmacological treatment and the lack of treatment in subjects diagnosed with carpal tunnel syndrome. Additionally, effects over the functionality of the affected upper limb will be evaluated and compared. Subjects will be invited to participate and randomly allocated to 4 different groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Median nerve neural mobilization | Experimental | Other: Median nerve neural mobilizationNon pharmaceutical, non invasive, physiotherapy technique; which consists of a passive and repetitive upper limb movement that seeks to induced median nerve gliding and incursions against surrounding connective tissue. Subjects will be treated 5 days per week during a total time lapse of 4 weeks. |
| Ibuprofen arginine | Active comparator | Drug: Ibuprofen ArginineOral tablet pharmaceutical treatment. Participants will be treated with a maximum of 1200 mg per day, subdivided in 3 intakes of 400 mg each 8 hours during a time lapse of 4 weeks. |
| Gabapentin | Active comparator | Drug: GabapentinOral capsule pharmaceutical treatment. Participants will be treated with a maximum of 600 mg per day, subdivided in 2 intakes of 300 mg each 12 hours during a time lapse of 4 weeks. |
| Control group | No intervention | –Waiting list control group. Participants that belong to the no intervention arm will be assigned to a waiting list to receive treatment. The participants will not receive treatment for carpal tunnel syndrome during a time lapse of 4 weeks. After this period of time, participants will begin the best treatment available. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must be medically diagnosed with unilateral carpal tunnel syndrome (with confirmative electrodiagnostic findings).
- Full understanding of written and spoken Spanish (language).
- Participants must freely consent to participate.
- The presence of positive Phalen and Tinel sign.
- The presence of carpal tunnel syndrome signs and symptoms
Key exclusion criteria (1 listed)
- The lack to meet inclusion criterions, the presence of cognitive impairment, tumors, cancer, recent (affected) upper limb surgery or trauma, pregnancy, metabolic neuropathy, obesity (body mass index over 30), participants who are not employed, deformities of the (affected) upper limb, recent skin injuries or infections (in the affected upper limb), autoimmune inflammatory conditions or flu type symptoms, allergy to gabapentin, allergy to ibuprofen arginine, and also: participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive).
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 |
|---|---|---|
| Median nerve neural mobilizationManual therapy maneuver performed in the upper limb. | Other | Median nerve neural mobilization |
| Ibuprofen ArginineAlso: SpedifenOral tablets | Drug | Ibuprofen arginine |
| GabapentinAlso: Neurontinoral capsules | Drug | Gabapentin |
Primary outcome
Distal upper limb pain
Time frame: Changes from baseline (measured immediately before the application of the first treatment) and 40 minutes after the application of the last treatment.
Assessed through the visual analog scale (VAS). The VAS is a psychometric response scale. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.The VAS is the most frequently used method to assess pain intensity. The scale will be displayed as a horizontal 10-cm line labelled at each end by descriptors such as 'no pain' (the minimum and best outcome possible) and 'worse pain ever' (maximum and worst outcome possible). The participant will mark the line to indicate pain severity and it is simply quantified by measuring the distance in centimeters from 0 (no pain) to the patient's marked rating.
1 secondary outcome
Upper limb function
Time frame: Changes from baseline (measured immediately before the application of the first treatment) at 40 minutes after the application of the last treatment.
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 10 Dec 2025.
- Background: PubMed 30810754Ilyas AM, Miller AJ, Graham JG, Matzon JL. A Prospective, Randomized, Double-Blinded Trial Comparing Acetaminophen, Ibuprofen, and Oxycodone for Pain Management After Hand Surgery. Orthopedics. 2019 Mar 1;42(2):110-115. doi: 10.3928/01477447-20190221-02. Epub 2019 Feb 27.
- Background: PubMed 30521680Choi GH, Wieland LS, Lee H, Sim H, Lee MS, Shin BC. Acupuncture and related interventions for the treatment of symptoms associated with carpal tunnel syndrome. Cochrane Database Syst Rev. 2018 Dec 2;12(12):CD011215. doi: 10.1002/14651858.CD011215.pub2.
- Background: PubMed 30502019Weinheimer K, Michelotti B, Silver J, Taylor K, Payatakes A. A Prospective, Randomized, Double-Blinded Controlled Trial Comparing Ibuprofen and Acetaminophen Versus Hydrocodone and Acetaminophen for Soft Tissue Hand Procedures. J Hand Surg Am. 2019 May;44(5):387-393. doi: 10.1016/j.jhsa.2018.10.014. Epub 2018 Nov 27.
- Background: PubMed 26433799Hadianfard M, Bazrafshan E, Momeninejad H, Jahani N. Efficacies of Acupuncture and Anti-inflammatory Treatment for Carpal Tunnel Syndrome. J Acupunct Meridian Stud. 2015 Oct;8(5):229-35. doi: 10.1016/j.jams.2014.11.005. Epub 2014 Nov 29.
- Background: PubMed 26327799Giuliani E, Bianchi A, Marcuzzi A, Landi A, Barbieri A. Ibuprofen timing for hand surgery in ambulatory care. Acta Ortop Bras. 2015 Jul-Aug;23(4):188-91. doi: 10.1590/1413-78522015230400736.
- Background: PubMed 28316723Riasi H, Rajabpour Sanati A, Salehi F, Salehian H, Ghaemi K. Analyzing the therapeutic effects of short wrist splint in patients with carpal tunnel syndrome (CTS) under ibuprofen treatment from an EMG-NCV perspective. J Med Life. 2015;8(Spec Iss 4):154-158.
- Background: PubMed 9627862Davis PT, Hulbert JR, Kassak KM, Meyer JJ. Comparative efficacy of conservative medical and chiropractic treatments for carpal tunnel syndrome: a randomized clinical trail. J Manipulative Physiol Ther. 1998 Jun;21(5):317-26.
- Background: PubMed 8176515Banta CA. A prospective, nonrandomized study of iontophoresis, wrist splinting, and antiinflammatory medication in the treatment of early-mild carpal tunnel syndrome. J Occup Med. 1994 Feb;36(2):166-8. doi: 10.1097/00043764-199402000-00012.
- Background: PubMed 30656171Hesami O, Haghighatzadeh M, Lima BS, Emadi N, Salehi S. The effectiveness of gabapentin and exercises in the treatment of carpal tunnel syndrome: a randomized clinical trial. J Exerc Rehabil. 2018 Dec 27;14(6):1067-1073. doi: 10.12965/jer.1836420.210. eCollection 2018 Dec.
- Background: PubMed 18381028Taverner D, Lisbona MP, Segales N, Docampo E, Calvet J, Castro S, Benito P. [Efficacy of gabapentin in the treatment of carpal tunnel syndrome]. Med Clin (Barc). 2008 Mar 22;130(10):371-3. doi: 10.1157/13117468. Spanish.
- Background: PubMed 28731977Dosenovic S, Jelicic Kadic A, Miljanovic M, Biocic M, Boric K, Cavar M, Markovina N, Vucic K, Puljak L. Interventions for Neuropathic Pain: An Overview of Systematic Reviews. Anesth Analg. 2017 Aug;125(2):643-652. doi: 10.1213/ANE.0000000000001998.
- Background: PubMed 19587471Erdemoglu AK. The efficacy and safety of gabapentin in carpal tunnel patients: open label trial. Neurol India. 2009 May-Jun;57(3):300-3. doi: 10.4103/0028-3886.53287.
- Individual participant dataSharing planned: No
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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.
Francisco Unda, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Median nerve neural mobilization, Ibuprofen Arginine and Gabapentin in people with Carpal Tunnel Syndrome, run by Francisco Unda Solano at 1 site in Venezuela.
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 5 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 10 Dec 2025. 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 Venezuela. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Distal upper limb pain (time frame: Changes from baseline (measured immediately before the application of the first treatment) and 40 minutes after the application of the last treatment.). 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 NCT04025203, which also lists 22 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 10 Dec 2025.