Functional Neurological Symptom DisorderMODIFINCT05455450
Eye MOvement DesensItisation and Reprocessing Therapy (EMDR) for FunctIonal Neurological Disorder (FND)
A study testing Eye movement desensitisation and reprocessing therapy and Neuropsychiatric care in people with Functional Neurological Symptom Disorder, run by South West London and St George's Mental Health NHS Trust at 2 sites in United Kingdom.
Trial summary
Functional Neurological Disorder (FND) is a problem with the functioning of the nervous system and how the brain and body send and receive signals, rather than due to neurological disease or injury. This causes a range of neurological symptoms such as seizures, shaking, weakness, and paralysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Neurological Symptom Disorder
- What is being tested?
- Eye movement desensitisation and reprocessing therapy and Neuropsychiatric care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 7 Nov 2022to 31 May 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Predominant diagnosis of functional seizures and/or functional motor disorder, with diagnosis confirmed by neurologist
- Aged 18 years or over
- Capacity to consent
- Willingness to attend regular psychological therapy sessions
- Reporting at least 1 traumatic event on the International Trauma Exposure Measure
Who cannot join
- Non-English speaking
- Current ongoing adversity that is likely to interfere with psychological therapy, e.g. domestic violence, homelessness, unresolved compensation claim/litigation
- Predominant diagnosis of Borderline Personality Disorder*
- Predominant diagnosis of chronic pain condition*, e.g. fibromyalgia
- Predominant diagnosis of chronic fatigue syndrome*
- Diagnosis of a psychotic disorder
Show all 14Show fewer
- Diagnosis of Dissociative Identity Disorder or score in clinical range on "identity disturbance" subscale of Multiscale Dissociation inventory
- Uncontrolled epileptic seizures
- Diagnosis of an eating disorder
- Current severe self harm or strong suicidal ideation that requires secondary care mental health services input
- Current alcohol or drug harmful-use or dependence
- Current diazepam use exceeding the equivalent of 10mg per day
- Currently attending individual psychological therapy focused on functional neurological disorder or other specialist functional neurological disorder-specific treatment such as inpatient/outpatient multi-disciplinary treatment or intensive functional neurological disorder-specific physiotherapy
- Comorbid diagnosis is acceptable, as long as functional neurological disorder is the predominant difficulty
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
South West London & St George's NHS Trust
London, SW17 7DJ
Neuropsychiatry Service
London, SW170QT
About this study
Official title: Randomised Feasibility Study of Eye Movement Desensitisation and Reprocessing Therapy (EMDR) for Functional Neurological Disorder (FND)
Functional Neurological Disorder (FND) is a problem with the functioning of the nervous system and how the brain and body send and receive signals, rather than due to neurological disease or injury. This causes a range of neurological symptoms such as seizures, shaking, weakness, and paralysis. The symptoms are associated with significant distress and disability. Treatment for FND in the United Kingdom is limited, and the evidence-base for treatment is poor, despite it being a common presentation. A psychological therapy called cognitive-behavioural therapy has been found to be beneficial, but it does not help everyone. EMDR is an effective treatment for posttraumatic stress disorder, but it can also be helpful with other conditions. There is a small amount of case study evidence that EMDR can be useful at treating FND, but proper scientific evaluation is needed.
This research aims to evaluate the possibility of delivering, and potential benefit, of EMDR for FND. If the study shows that it is feasible and potentially beneficial, a larger trial will be designed. The study will recruit 50 participants who have specific functional neurological symptoms: weakness, walking difficulties, jerks, shaking, and/or seizures from a Neuropsychiatry Service. Participants will be allocated to EMDR, and routine medical appointments, or routine medical appointments alone. Allocation will be carried out by a computer programme. Those allocated to EMDR will be offered 8-16 weekly therapy sessions, completed within 6 months, and follow-up session 1 month after therapy has ended. Participants will be able to choose whether to attend therapy in-person or via an online video conferencing platform. Participants will complete questionnaires regarding health-related functioning, FND, mental health, and healthcare utilisation. These questionnaires will be completed at the beginning, 3 months, 6 months, and 9 months.
Some participants will attend interviews about experiences of treatment.
Read the detailed description
Background:
Functional neurological disorder (FND) refers to an involuntary loss of control over and/or aberrant perception of the body. Common presenting symptoms are functional (non-epileptic) seizures, and functional motor disorder, e.g. walking difficulties, weakness, or tremor. Treatment in the United Kingdom is inconsistently available, and there is inequity of care compared to other neurological conditions. There are no established standards of care for this patient group. FND is associated with large health- and social-care costs. Greater access to effective treatments would lead to reduced distress and disability for patients with FND; and reduce unnecessary costs to the NHS.
This research proposes using eye-movement desensitisation and reprocessing therapy (EMDR) as a treatment for FND. EMDR is an evidence-based treatment for post-traumatic stress disorder (PTSD), but its use for other conditions is growing. A FND-specific EMDR protocol will be developed and tested, and if the intervention proves feasible with promising clinical outcomes, progression to a substantive study could take place.
Aims and Objectives:
- Test the acceptability and feasibility of an FND-specific EMDR intervention protocol, delivered physically or virtually.
II. Investigate the value of a range of outcome measures, to determine the outcome measure with greatest symptom improvement and the required sample size, for a substantive RCT.
III. Carry out semi-structured interviews with participants and therapists to explore experiences of EMDR and the trial; informing the intervention and design for a substantive trial.
Methods:
50 adult patients with a diagnosis of FND will be recruited via a Neuropsychiatry Service. The study will be a single-blind randomised controlled trial (RCT) with two arms: EMDR (plus standard neuropsychiatric care; NPC) and standard NPC. The two groups will be compared at baseline (T0), 3 months (T1), 6 months (T2), and 9 months (T3). Measures of feasibility include safety, recruitment, retention, and treatment adherence and acceptability. Clinical outcome measures assess health-related functioning/quality of life, FND, depression, anxiety, PTSD, dissociation, service-utilisation and other costs. Patient-rated improvement and satisfaction will also be assessed. Feasibility outcomes will be summarised using descriptive statistics. Exploratory analyses using (linear/logistic) Mixed Effect Models will examine the rate of change in intervention and control groups' clinical outcome measures across the four time-points.
After the intervention period, a sample of participants, and clinicians, will be invited to attend semi-structured interviews on trial experiences. The interviews will be analysed using reflexive thematic analysis.
- Conditions
- Functional Neurological Symptom Disorder
- Being tested
- Eye movement desensitisation and reprocessing therapy, Neuropsychiatric care
- Keywords
- Functional neurological disorder, FND
- Medical subject headings
- Conversion Disorder, Frontonasal dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye movement desensitisation and reprocessing therapyOther
Also called EMDR
Up to 16 EMDR sessions (minimum of 8 sessions), and 1-month follow-up session, as well as attending neuropsychiatric appointments (NPC). Participants will be given the choice of attending EMDR physically face-to-face or virtually via a video-consultation platform. Sessions will normally be attended weekly, with treatment completed within 6 months. Sessions will be 60-90 minutes long. EMDR will follow the standard 8-phase protocol, with additions so that it is tailored for FND presentations. The FND-specific EMDR therapy protocol has been developed for the trial by the chief investigator.
Neuropsychiatric careOther
Standard medical care consisting of 1-3 30 minute appointments with neuropsychiatrist over the course of the 9-month trial period.
| Study group | Role | What they receive |
|---|---|---|
| EMDR + NPC | Experimental | 8-16 eye movement desensitisation and reprocessing therapy (EMDR) sessions, plus 1 month follow up session after the therapy has ended. Participants will also attend neuropsychiatric follow-up appointments as part of standard medical care. Receives: Other: Eye movement desensitisation and reprocessing therapy; Other: Neuropsychiatric care |
| Neuropsychiatric Care (NPC) | Other | Standard medical care Receives: Other: Neuropsychiatric care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Percentage of potentially eligible participants attending screening interview
Measured: 12 months (recruitment stage)
Intervention adherence
Percentage of participants randomised to EMDR+NPC who complete therapy
Measured: 18 months (intervention stage)
Outcome measures completion
Percentage of participants who complete outcome measures at all 4 time points
Measured: 12 months (9-month follow-up stage)
Secondary outcomes (8)
EQ-5D-5L
Brief health questionnaire
Measured: 4 time points over 9 months (trial period)
Ecological Momentary Assessment (EMA) of FND symptoms
Using an App, FND symptoms will be rated in terms of frequency, severity, interference with daily functioning, associated distress and preoccupation with
Measured: 4 time points over 9 months (trial period)
PHQ-9
Self-rated measure of depression
Measured: 4 time points over 9 months (trial period)
GAD-7
Self-rated measure of anxiety
Measured: 4 time points over 9 months (trial period)
International Trauma Questionnaire (ITQ)
Measure of PTSD and Complex PTSD
Measured: 4 time points over 9 months (trial period)
Multiscale Dissociation Inventory
Measure of dissociation
Measured: 4 time points over 9 months (trial period)
Adult Service Use Schedule (AD-SUS)
Self-report measure of service use
Measured: 2 time points over 9 months (trial period)
World Health Organisation Disability Assessment Schedule (WHODAS 2.0)
Health-Related Quality of life/functioning measure
Measured: 4 time points over 9 months (trial period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start7 Nov 2022
- Primary completion31 Aug 2024
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Functional Neurological Symptom DisorderStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Participants will be randomised into EMDR (plus neuropsychiatric care; NPC) or NPC. A stratified block randomisation will be used to ensure similar numbers of patients with predominant functional seizures or functional motor disorder, and PTSD/non-PTSD are relatively equal across arms.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- South West London and St George's Mental Health NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah R Cope, DClinPsy, Principal investigator, South West London & St. George's Mental Health NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455450
- Sponsor's protocol ID
- COPS1001
- Acronym
- MODIFI
- Status last verified
- Sep 2025
- First submitted
- 14 Jun 2022
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pritomanova I, Cope SR, James B, Edwards MJ, Smith JG, El-Leithy S, Vanzan S, Hogwood P, Golder D, Turner KJ, Billings J. The journey to diagnosis and care of functional neurological disorder (FND). PLoS One. 2026 Apr 22;21(4):e0328321. doi: 10.1371/journal.pone.0328321. eCollection 2026.
PubMed 42018562Cope SR, Smith JG, El-Leithy S, Vanzan S, Hogwood P, Golder D, Turner KJ, Crowley M, Billings J, Pick S, Pentland C, Edwards MJ. Randomised feasibility study evaluating eye movement desensitisation and reprocessing therapy for functional neurological disorder (MODIFI). J Neurol. 2025 Jul 8;272(8):493. doi: 10.1007/s00415-025-13219-5.
PubMed 40627223Cope SR, Smith JG, El-Leithy S, Vanzan S, Pentland C, Pick S, Golder D, Hogwood P, Turner K, Billings J, Edwards MJ. MODIFI: protocol for randomised feasibility study of eye-movement desensitisation and reprocessing therapy (EMDR) for functional neurological disorder (FND). BMJ Open. 2023 Jun 2;13(6):e073727. doi: 10.1136/bmjopen-2023-073727.
PubMed 37270188
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Feasibility Study of Eye Movement Desensitisation and Reprocessing Therapy (EMDR) for Functional Neurological Disorder (FND)
- ClinicalTrials.gov ID
- NCT05455450
- Acronym / sponsor ID
- MODIFI / COPS1001
- Conditions
- Functional Neurological Symptom Disorder
- Keywords
- Functional neurological disorder, FND
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- South West London and St George's Mental Health NHS TrustUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 13 Jul 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.
Functional Neurological Disorder (FND) is a problem with the functioning of the nervous system and how the brain and body send and receive signals, rather than due to neurological disease or injury. This causes a range of neurological symptoms such as seizures, shaking, weakness, and paralysis. The symptoms are associated with significant distress and disability. Treatment for FND in the United Kingdom is limited, and the evidence-base for treatment is poor, despite it being a common presentation. A psychological therapy called cognitive-behavioural therapy has been found to be beneficial, but it does not help everyone. EMDR is an effective treatment for posttraumatic stress disorder, but it can also be helpful with other conditions. There is a small amount of case study evidence that EMDR can be useful at treating FND, but proper scientific evaluation is needed.
This research aims to evaluate the possibility of delivering, and potential benefit, of EMDR for FND. If the study shows that it is feasible and potentially beneficial, a larger trial will be designed. The study will recruit 50 participants who have specific functional neurological symptoms: weakness, walking difficulties, jerks, shaking, and/or seizures from a Neuropsychiatry Service. Participants will be allocated to EMDR, and routine medical appointments, or routine medical appointments alone. Allocation will be carried out by a computer programme. Those allocated to EMDR will be offered 8-16 weekly therapy sessions, completed within 6 months, and follow-up session 1 month after therapy has ended. Participants will be able to choose whether to attend therapy in-person or via an online video conferencing platform. Participants will complete questionnaires regarding health-related functioning, FND, mental health, and healthcare utilisation. These questionnaires will be completed at the beginning, 3 months, 6 months, and 9 months.
Some participants will attend interviews about experiences of treatment.
Detailed description
Background:
Functional neurological disorder (FND) refers to an involuntary loss of control over and/or aberrant perception of the body. Common presenting symptoms are functional (non-epileptic) seizures, and functional motor disorder, e.g. walking difficulties, weakness, or tremor. Treatment in the United Kingdom is inconsistently available, and there is inequity of care compared to other neurological conditions. There are no established standards of care for this patient group. FND is associated with large health- and social-care costs. Greater access to effective treatments would lead to reduced distress and disability for patients with FND; and reduce unnecessary costs to the NHS.
This research proposes using eye-movement desensitisation and reprocessing therapy (EMDR) as a treatment for FND. EMDR is an evidence-based treatment for post-traumatic stress disorder (PTSD), but its use for other conditions is growing. A FND-specific EMDR protocol will be developed and tested, and if the intervention proves feasible with promising clinical outcomes, progression to a substantive study could take place.
Aims and Objectives:
- Test the acceptability and feasibility of an FND-specific EMDR intervention protocol, delivered physically or virtually.
II. Investigate the value of a range of outcome measures, to determine the outcome measure with greatest symptom improvement and the required sample size, for a substantive RCT.
III. Carry out semi-structured interviews with participants and therapists to explore experiences of EMDR and the trial; informing the intervention and design for a substantive trial.
Methods:
50 adult patients with a diagnosis of FND will be recruited via a Neuropsychiatry Service. The study will be a single-blind randomised controlled trial (RCT) with two arms: EMDR (plus standard neuropsychiatric care; NPC) and standard NPC. The two groups will be compared at baseline (T0), 3 months (T1), 6 months (T2), and 9 months (T3). Measures of feasibility include safety, recruitment, retention, and treatment adherence and acceptability. Clinical outcome measures assess health-related functioning/quality of life, FND, depression, anxiety, PTSD, dissociation, service-utilisation and other costs. Patient-rated improvement and satisfaction will also be assessed. Feasibility outcomes will be summarised using descriptive statistics. Exploratory analyses using (linear/logistic) Mixed Effect Models will examine the rate of change in intervention and control groups' clinical outcome measures across the four time-points.
After the intervention period, a sample of participants, and clinicians, will be invited to attend semi-structured interviews on trial experiences. The interviews will be analysed using reflexive thematic analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomised into EMDR (plus neuropsychiatric care; NPC) or NPC. A stratified block randomisation will be used to ensure similar numbers of patients with predominant functional seizures or functional motor disorder, and PTSD/non-PTSD are relatively equal across arms.
| Arm | Type | Receives |
|---|---|---|
| EMDR + NPC | Experimental | Other: Eye movement desensitisation and reprocessing therapy, Other: Neuropsychiatric care8-16 eye movement desensitisation and reprocessing therapy (EMDR) sessions, plus 1 month follow up session after the therapy has ended. Participants will also attend neuropsychiatric follow-up appointments as part of standard medical care. |
| Neuropsychiatric Care (NPC) | Other | Other: Neuropsychiatric careStandard medical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Predominant diagnosis of functional seizures and/or functional motor disorder, with diagnosis confirmed by neurologist
- Aged 18 years or over
- Capacity to consent
- Willingness to attend regular psychological therapy sessions
- Reporting at least 1 traumatic event on the International Trauma Exposure Measure
Key exclusion criteria (14 listed)
- Non-English speaking
- Current ongoing adversity that is likely to interfere with psychological therapy, e.g. domestic violence, homelessness, unresolved compensation claim/litigation
- Predominant diagnosis of Borderline Personality Disorder*
- Predominant diagnosis of chronic pain condition*, e.g. fibromyalgia
- Predominant diagnosis of chronic fatigue syndrome*
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 |
|---|---|---|
| Eye movement desensitisation and reprocessing therapyAlso: EMDRUp to 16 EMDR sessions (minimum of 8 sessions), and 1-month follow-up session, as well as attending neuropsychiatric appointments (NPC). Participants will be given the choice of attending EMDR physically face-to-face or virtually via a video-consultation platform. Sessions will normally be attended weekly, with treatment completed within 6 months. Sessions will be 60-90 minutes long. EMDR will follow the standard 8-phase protocol, with additions so that it is tailored for FND presentations. The FND-specific EMDR therapy protocol has been developed for the trial by the chief investigator. | Other | EMDR + NPC |
| Neuropsychiatric careStandard medical care consisting of 1-3 30 minute appointments with neuropsychiatrist over the course of the 9-month trial period. | Other | EMDR + NPC, Neuropsychiatric Care (NPC) |
Primary outcome
Recruitment rate
Time frame: 12 months (recruitment stage)
Percentage of potentially eligible participants attending screening interview
Intervention adherence
Time frame: 18 months (intervention stage)
Percentage of participants randomised to EMDR+NPC who complete therapy
Outcome measures completion
Time frame: 12 months (9-month follow-up stage)
Percentage of participants who complete outcome measures at all 4 time points
8 secondary outcomes
EQ-5D-5L
Time frame: 4 time points over 9 months (trial period)
Ecological Momentary Assessment (EMA) of FND symptoms
Time frame: 4 time points over 9 months (trial period)
PHQ-9
Time frame: 4 time points over 9 months (trial period)
GAD-7
Time frame: 4 time points over 9 months (trial period)
International Trauma Questionnaire (ITQ)
Time frame: 4 time points over 9 months (trial period)
Multiscale Dissociation Inventory
Time frame: 4 time points over 9 months (trial period)
Adult Service Use Schedule (AD-SUS)
Time frame: 2 time points over 9 months (trial period)
World Health Organisation Disability Assessment Schedule (WHODAS 2.0)
Time frame: 4 time points over 9 months (trial period)
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 16 Sep 2025.
- Derived from this study: PubMed 42018562Pritomanova I, Cope SR, James B, Edwards MJ, Smith JG, El-Leithy S, Vanzan S, Hogwood P, Golder D, Turner KJ, Billings J. The journey to diagnosis and care of functional neurological disorder (FND). PLoS One. 2026 Apr 22;21(4):e0328321. doi: 10.1371/journal.pone.0328321. eCollection 2026.
- Derived from this study: PubMed 40627223Cope SR, Smith JG, El-Leithy S, Vanzan S, Hogwood P, Golder D, Turner KJ, Crowley M, Billings J, Pick S, Pentland C, Edwards MJ. Randomised feasibility study evaluating eye movement desensitisation and reprocessing therapy for functional neurological disorder (MODIFI). J Neurol. 2025 Jul 8;272(8):493. doi: 10.1007/s00415-025-13219-5.
- Derived from this study: PubMed 37270188Cope SR, Smith JG, El-Leithy S, Vanzan S, Pentland C, Pick S, Golder D, Hogwood P, Turner K, Billings J, Edwards MJ. MODIFI: protocol for randomised feasibility study of eye-movement desensitisation and reprocessing therapy (EMDR) for functional neurological disorder (FND). BMJ Open. 2023 Jun 2;13(6):e073727. doi: 10.1136/bmjopen-2023-073727.
- 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.
Sarah R Cope, DClinPsy principal investigator
South West London & St. George's Mental Health NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye movement desensitisation and reprocessing therapy and Neuropsychiatric care in people with Functional Neurological Symptom Disorder, run by South West London and St George's Mental Health NHS Trust at 2 sites in United Kingdom.
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 14 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 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
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?
Recruitment rate (time frame: 12 months (recruitment stage)). The study lists 3 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 NCT05455450, which also lists 3 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 16 Sep 2025.