Phantom Limb PainPHANTOM RELIEFNCT04103983
Sensory Retraining for Phantom Limb Pain
A study testing Sensory retraining device in people with Phantom Limb Pain, run by Teesside University at 1 site in United Kingdom.
Trial summary
86-87% of people who have had an amputation still feel pain in the limb that has been amputated - Phantom limb pain (PLP). Sensory retraining is a form of treatment for PLP where a special form of electrical stimulation is delivered to the residual limb. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phantom Limb Pain
- What is being tested?
- Sensory retraining device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Feb 2024to 18 Jul 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
- Living in the UK
- All Genders
- Aged ≥18 years of age
- Women who self-declare:
- that they are post-menopausal, or permanently sterile*,
- or -
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- that it is physiologically impossible that they could be pregnant and not be aware they are.
- Women who do not make one of the two declarations above, are only eligible if:
- they undertake a highly sensitive urine pregnancy test which is negative, prior (and as close in time as is possible) to beginning the treatment phase of the Trial,
- and -
- they agree to use a highly, or acceptably effective, contraceptive measure** during the treatment phase of the Trial.
- fully healed residual limb (or stump) ***
- single or multi limb amputation with the intervention applied to the participants limb of choice
- experienced PLP rated as ≥4 on a 0-10 scale on at least 2 days in the week prior to enrolment
- agree to inform us of the use of any new (to them) prescribed drug for their pain during the trial
- any prescribed pharmacological treatment for the treatment of PLP stable for one month prior to commencing the trial , and agree not to undertake any non-pharmacological treatments for their PLP during the trial (e.g., mirror therapy)
- agree to inform us of any other health care received related to the amputated limb during the trial (e.g., physiotherapy or occupational therapy) whether specific to PLP or not
- any previous non-pharmacological PLP treatment must have terminated at least 1 month prior to commencing the trial
- Participants will need access to a mobile smart phone and a device (laptop, iPad etc.) at home to receive text messages and take part in secure video conference calls and completion of online forms.
- Post menopause is defined as no menses for 12 months without an alternative medical cause. Permanently sterile methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy
- Highly effective contraceptive methods being:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation either oral, intravaginal, or transdermal
- Progestogen only hormonal contraception associated with inhibition of ovulation, either oral, injectable, or implantable
- Intrauterine device IUD
- Intrauterine hormone-releasing system IUS
- Sexual abstinence
- Acceptably effective contraceptive methods being:
- Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
- Male or female condom with or without spermicide
- Cap, diaphragm or sponge with spermicide
- A combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods)
- Fully healed criteria: no bleeding, no oozing, no broken skin, no obvious sign of infection, such as swelling or redness, around the scar.
Who cannot join
- lacking Mental Capacity to give Informed Consent
- women who self-declare that they are pregnant, or that they will be trying to become pregnant, during the treatment phase of the Trial*
- impaired sensation as measured by hot/ cold test and sharp/ blunt test
- unable to read and speak English - the questionnaires being used have not been translated and validated in multiple languages and no facility is available to conduct nor translate/ back-translate semi-structured interview data
- epileptic
- active deep vein thrombosis, thrombophlebitis, or varicose veins
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- fitted with a pacemaker
- has a metal implant in the area to be stimulated
- any residual limb complications such as cellulitis, wounds, infections etc.
- Active regions of known or suspected malignancy
- Any actively bleeding tissue or to persons with untreated haemorrhagic disorders
- Participating in any research trial of any intervention hypothesised to affect PLP
- Any current or recent history of substance misuse, alcohol, or drug dependency
- Any person, otherwise eligible, who commences any non-pharmacological treatment for PLP during the trial period
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Teesside University
Middlesbrough, Tees Valley, TS1 3BX
About this study
Official title: An Investigation of the Efficacy of a Novel Sensory Discrimination Training Device for the Management of Phantom Limb Pain: A Randomised, Single-blind, Placebo-controlled Trial. [PHANTOM RELIEF Trial]
86-87% of people who have had an amputation still feel pain in the limb that has been amputated - Phantom limb pain (PLP). Sensory retraining is a form of treatment for PLP where a special form of electrical stimulation is delivered to the residual limb.
The theory is that this stimulation changes activity in the brain that helps to reduce the person's pain. Two new types of sensory retraining device for the treatment of phantom limb pain have been developed. One type requires the user to interact with the device while the other is a non-interactive device. Both devices are new so it is unknown as to how well they may work, or which is best, therefore both will be tested in this study.
This study will be undertaken remotely, using video call, telephone and email for communication. The study will compare the effect of both devices for efficacy. One hundred people with PLP will be recruited from the NHS and the general public and randomised to receive either the interactive or non-interactive device or their placebo equivalents. A health care professional will train the research participants how to use their device. Participants will then use their device at home for 3 weeks. To ensure that they are using their devices as required, the researchers will keep in contact throughout the three week treatment period, using a schedule of video calls, weekly phone calls and daily texts. Pain and function will be measured before treatment, after treatment and at a 3 month follow-up. Twelve participants will also be invited to a one-to-one interview to give their experience of the acceptability and usability of their device.
- Conditions
- Phantom Limb Pain
- Being tested
- Sensory retraining device
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory retraining deviceDevice
All participants will be given a device to keep at home and will be asked to use it for 60 minutes each day, as one block, or as multiple shorter sessions of 20 minutes minimum duration. Participants will be asked to use their device on 15 of the 21 days. They will be asked to spread out the use of the device over the 21 days. Participants are asked to record device use in a diary.
| Study group | Role | What they receive |
|---|---|---|
| Sensory Retraining Interactive Device | Active comparator | The interactive device is a sensory retraining device. A pad consisting of twelve equally spaced electrodes is placed over the residual limb. This pad is connected to a handheld device which delivers an electrical current to the electrodes. The type of electrical current is similar to a TENS device. The device stimulates the skin via one of the electrodes, with either a single, or a rapid burst of pulse(s). The device touch screen then presents the questions, Which electrode (location) was stimulated? Was a single continuous or a rapid burst of pulses given (stimulation type)? The user responds via the screen and is told if they are correct. If correct, a new stimulus is delivered (different location and type) and the process repeated. If incorrect, the user is informed of the correct response, the same stimulation (location and type) is repeated once before moving onto to a new stimulus. Receives: Device: Sensory retraining device |
| Placebo Sensory Retraining Non-Interactive Device | Placebo comparator | The placebo non-interactive device is physically visually identical to the interactive device. This device delivers the stimulation using microcurrents that the participants may or may not feel. There is no interaction required with this device i.e. there is no Q\&A element, feedback nor response dependent progression. Receives: Device: Sensory retraining device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The short form McGill Pain Questionnaire (SF-MPQ-2)
The primary outcome will be the total score of the McGill Pain Questionnaire revised (SF-MPQ-2)8 20 at the 3-week time point. The SF-MPQ-2 is a commonly used questionnaire to assess pain levels in a range of pain conditions. There are 22 items/ pain descriptors across 4 pain sub-scales/ domains: continuous, intermittent, neuropathic, and affective. Participants rate each item on an 11-point (0-10) scale, where 0 = none and 10 = worst possible pain. The mean of the 22 items provides the SF-MPQ-2 total score. Two or more missing responses on any sub-scale results in an invalid outcome. A targeted effect size of 1 unit difference between groups will be used.
Measured: Day 1 (baseline prior to start) and Day 21 (end) of treatment period
Secondary outcomes (12)
Overall Pain: Visual Analogue Scale (100mm):
Participants will be asked to rate their phantom limb pain over the last week using a pain visual analogue scale consisting of a 100mm line with anchor statements of 0 representing no pain and 100 the worst pain imaginable. The participant will be asked to place a mark through the line to represent their pain. Participants will be asked to record the number of phantom limb pain episodes they have experienced over the past week.
Measured: Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
Frequency adjusted pain score: (0-100)
Participants will be asked to record the frequency of PLP episodes they have experienced over the past week from 1 = all the time to 5 = Once a day or less per week. The overall pain score will be divided by the frequency value to create a composite frequency adjusted pain score ranging from 0-100.
Measured: Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
General Subjective Outcome Score (GSOS)
Participants will be asked to rate their level of improvement Choosing one of six options, ranging from "a lot worse" to "completely better" (Harland et al. 2015).
Measured: Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
The short form McGill Pain Questionnaire (SF-MPQ-2)
The short form McGill Pain Questionnaire (SF-MPQ-2) (Dworkin et al, 2009):
The short from McGill Pain Questionnaire (SF-MPQ-2) is a commonly used questionnaire to assess pain levels in a range of pain conditions. Twenty words which describe pain across the sensory, affective, evaluative and miscellaneous domains are presented to the participant who is asked to choose which word best describes their pain in the last week and to rate how intense that descriptor of pain was on a 0-10 scale.
Measured: 3 month follow up point post end of treatment period
Trinity Amputation and prosthetic evaluation scale (modified) (TAPES)
Participants will be asked to complete a modified version of the Trinity Amputation and prosthetics evaluation scale (TAPES scale).The TAPES has been modified in that it only asks about issues specific to PLP, residual limb (or stump) pain, and phantom sensations.
Measured: Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
EQ5D5L
A brief easy to use validated measure of quality of life. The EQ5D contains five items related to mobility, self-care, usual activities, pain and anxiety/depression. It also contains a visual analogue scale for rating general health.
Measured: Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
Sleep Disturbance
Participants will be asked to complete the PROMIS Short Form v.1.0 - Sleep Disturbance 4a questionnaire. This is a self-reported questionnaire reporting perceptions of sleep quality, sleep depth, and restoration associated with sleep. It assesses sleep disturbance over the past seven days. There are four questions, each containing a 5-point Likert Scale, ranging from Very Poor to Very Good. The questions are then combined to create a score out of 100 (Gershan et al. 2010).
Measured: Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
Participant satisfaction
Six item rating scale. Participants will be asked to answer the question,
"How likely are you to recommend the device to other people who had phantom limb pain following an amputation?" by choosing one of six options, ranging from "extremely likely" to "extremely unlikely".
Measured: Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
Device Usability
After treatment, to investigate usability, all participants will be asked to rate how easy do you think the device was to use on a Visual Analogue Scale (VAS) (100mm) with 0 representing not at all easy to use and 100 representing extremely easy to use.
Measured: Day 21 (end) of treatment period
Study Diary (medication use/device use/pain levels)
Participants will be asked to report on their daily medication usage over the duration of the trial in a study diary. The participant will be sent a daily notification by the SMART-TRIAL platform to remind them to complete the study diary for the three week treatment period. The diary will ask for the frequency, dosage and class of medication taken each day. In addition, patients will be asked to rate their phantom limb pain on a scale from 0-10 each day, the frequency of those pain episodes, and to record how many minutes they used the device each day.
Measured: Each Day Days 1 (baseline prior to start) to Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
Concordance with Protocol
The frequency and duration of use of the SP1X device will be documented in the daily study diary and compared against the protocol that participants were asked to adhere to. This data will also be automatically captured by the device.
Measured: Each Day Days 1 (baseline prior to start) to Day 21 (end) of treatment period
Credibility of Devices
Participants will be asked Which of the following four devices do you think you received? 1. A real interactive device, 2. A sham/placebo interactive device, 3. A real non-interactive device or 4. A sham/placebo non-interactive device? And then How confident are you that your device was (form inserts answer 1,2,3 or 4) on a 0-100 scale with 0 being not at all confident and 100 being completely confident?
Measured: At 3 month follow up point post end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start9 Feb 2024
- Primary completion18 May 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Phantom Limb 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, single blind, controlled, mixed-methods study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Collaborators
- 2PD Ltd, Royal Commission for the Exhibition of 1851
- Responsible party
- Principal investigator, Sarah Oatway, Teesside University
- Investigators
- Cormac Ryan, Professor, Principal investigator, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103983
- Sponsor's protocol ID
- 2023 July 16692
- Other IDs
- 250337
- Acronym
- PHANTOM RELIEF
- Status last verified
- Sep 2025
- First submitted
- 20 Sep 2019
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oatway S, Martin D, Graham A, Batterham A, MacSween A, Smith S, Ravindran D, Ryan C. Efficacy of a novel sensory discrimination training device for the management of phantom limb pain: protocol for a randomised placebo-controlled trial. BMJ Open. 2025 Nov 9;15(11):e101657. doi: 10.1136/bmjopen-2025-101657.
PubMed 41213687
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Efficacy of a Novel Sensory Discrimination Training Device for the Management of Phantom Limb Pain: A Randomised, Single-blind, Placebo-controlled Trial. [PHANTOM RELIEF Trial]
- ClinicalTrials.gov ID
- NCT04103983
- Acronym / sponsor ID
- PHANTOM RELIEF / 2023 July 16692
- Conditions
- Phantom Limb Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Collaborators
- 2PD Ltd, Royal Commission for the Exhibition of 1851
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 18 May 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 26 Sep 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.
86-87% of people who have had an amputation still feel pain in the limb that has been amputated - Phantom limb pain (PLP). Sensory retraining is a form of treatment for PLP where a special form of electrical stimulation is delivered to the residual limb.
The theory is that this stimulation changes activity in the brain that helps to reduce the person's pain. Two new types of sensory retraining device for the treatment of phantom limb pain have been developed. One type requires the user to interact with the device while the other is a non-interactive device. Both devices are new so it is unknown as to how well they may work, or which is best, therefore both will be tested in this study.
This study will be undertaken remotely, using video call, telephone and email for communication. The study will compare the effect of both devices for efficacy. One hundred people with PLP will be recruited from the NHS and the general public and randomised to receive either the interactive or non-interactive device or their placebo equivalents. A health care professional will train the research participants how to use their device. Participants will then use their device at home for 3 weeks. To ensure that they are using their devices as required, the researchers will keep in contact throughout the three week treatment period, using a schedule of video calls, weekly phone calls and daily texts. Pain and function will be measured before treatment, after treatment and at a 3 month follow-up. Twelve participants will also be invited to a one-to-one interview to give their experience of the acceptability and usability of their device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, single blind, controlled, mixed-methods study.
| Arm | Type | Receives |
|---|---|---|
| Sensory Retraining Interactive Device | Active comparator | Device: Sensory retraining deviceThe interactive device is a sensory retraining device. A pad consisting of twelve equally spaced electrodes is placed over the residual limb. This pad is connected to a handheld device which delivers an electrical current to the electrodes. The type of electrical current is similar to a TENS device. The device stimulates the skin via one of the electrodes, with either a single, or a rapid burst of pulse(s). The device touch screen then presents the questions, Which electrode (location) was stimulated? Was a single continuous or a rapid burst of pulses given (stimulation type)? The user responds via the screen and is told if they are correct. If correct, a new stimulus is delivered (different location and type) and the process repeated. If incorrect, the user is informed of the correct response, the same stimulation (location and type) is repeated once before moving onto to a new stimulus. |
| Placebo Sensory Retraining Non-Interactive Device | Placebo comparator | Device: Sensory retraining deviceThe placebo non-interactive device is physically visually identical to the interactive device. This device delivers the stimulation using microcurrents that the participants may or may not feel. There is no interaction required with this device i.e. there is no Q\&A element, feedback nor response dependent progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Living in the UK
- All Genders
- Aged ≥18 years of age
- Women who self-declare:
- that they are post-menopausal, or permanently sterile*,
Key exclusion criteria (14 listed)
- lacking Mental Capacity to give Informed Consent
- women who self-declare that they are pregnant, or that they will be trying to become pregnant, during the treatment phase of the Trial*
- impaired sensation as measured by hot/ cold test and sharp/ blunt test
- unable to read and speak English - the questionnaires being used have not been translated and validated in multiple languages and no facility is available to conduct nor translate/ back-translate semi-structured interview data
- epileptic
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 |
|---|---|---|
| Sensory retraining deviceAll participants will be given a device to keep at home and will be asked to use it for 60 minutes each day, as one block, or as multiple shorter sessions of 20 minutes minimum duration. Participants will be asked to use their device on 15 of the 21 days. They will be asked to spread out the use of the device over the 21 days. Participants are asked to record device use in a diary. | Device | Placebo Sensory Retraining Non-Interactive Device, Sensory Retraining Interactive Device |
Primary outcome
The short form McGill Pain Questionnaire (SF-MPQ-2)
Time frame: Day 1 (baseline prior to start) and Day 21 (end) of treatment period
The primary outcome will be the total score of the McGill Pain Questionnaire revised (SF-MPQ-2)8 20 at the 3-week time point. The SF-MPQ-2 is a commonly used questionnaire to assess pain levels in a range of pain conditions. There are 22 items/ pain descriptors across 4 pain sub-scales/ domains: continuous, intermittent, neuropathic, and affective. Participants rate each item on an 11-point (0-10) scale, where 0 = none and 10 = worst possible pain. The mean of the 22 items provides the SF-MPQ-2 total score. Two or more missing responses on any sub-scale results in an invalid outcome. A targeted effect size of 1 unit difference between groups will be used.
12 secondary outcomes
Overall Pain: Visual Analogue Scale (100mm):
Time frame: Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
Frequency adjusted pain score: (0-100)
Time frame: Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
General Subjective Outcome Score (GSOS)
Time frame: Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
The short form McGill Pain Questionnaire (SF-MPQ-2)
Time frame: 3 month follow up point post end of treatment period
Trinity Amputation and prosthetic evaluation scale (modified) (TAPES)
Time frame: Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
EQ5D5L
Time frame: Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
Sleep Disturbance
Time frame: Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
Participant satisfaction
Time frame: Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
Device Usability
Time frame: Day 21 (end) of treatment period
Study Diary (medication use/device use/pain levels)
Time frame: Each Day Days 1 (baseline prior to start) to Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
Concordance with Protocol
Time frame: Each Day Days 1 (baseline prior to start) to Day 21 (end) of treatment period
Credibility of Devices
Time frame: At 3 month follow up point post end of 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 29 Sep 2025.
- Derived from this study: PubMed 41213687Oatway S, Martin D, Graham A, Batterham A, MacSween A, Smith S, Ravindran D, Ryan C. Efficacy of a novel sensory discrimination training device for the management of phantom limb pain: protocol for a randomised placebo-controlled trial. BMJ Open. 2025 Nov 9;15(11):e101657. doi: 10.1136/bmjopen-2025-101657.
- 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.
Cormac Ryan, Professor principal investigator
Teesside University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory retraining device in people with Phantom Limb Pain, run by Teesside University at 1 site 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 32 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 29 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 1 site 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. Some participants in this study may receive a placebo. 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?
The short form McGill Pain Questionnaire (SF-MPQ-2) (time frame: Day 1 (baseline prior to start) and Day 21 (end) of treatment period). 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 NCT04103983, which also lists 1 linked publication.
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 29 Sep 2025.