PainFOKUSNCT07050758
Pain Reprocessing Therapy for Chronic Widespread Pain: a SCED Study
A study testing Pain Reprocessing Therapy in people with Pain and Chronic Widespread Pain, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Chronic Widespread Pain (CWP) is classified as a Chronic Primary Pain syndrome in the ICD-11 and is considered a major type of nociplastic pain with an estimated prevalence of up to 8-10% in the general population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Chronic Widespread Pain, Chronic Pain
- What is being tested?
- Pain Reprocessing Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNorway
- Study dates
- 7 May 2025to 30 Sep 2026
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 (inclusive)
- Qualifying for Chronic Widespread Pain (CWP), as described in ICD-11 (an existing diagnosis of fibromyalgia qualifies for CWP)
- Baseline pain with an average intensity of at least 4/10 that has lasted for 3 months or longer
- If on medication that could potentially interfere with study participation or outcomes as evaluated by the study physician, stable doses of medication for 6 weeks prior to entering the study and during participation
- Living in Norway
- Fluent in Norwegian
- Normal or corrected-to-normal vision
- Access to smartphone or equivalent for use of app during study
Who cannot join
- Current comorbid acute pain condition (pain from acute illness, injury, infection, or similar in the past 3 weeks)
- Beck Depression Index (BDI) score more than 30
- Clinical high risk for suicidality (BDI short form item 7 on suicidality rated ≥ 2, or modaterate/high scores for suicidality in M.I.N.I. interview)
- Current psychological therapy for pain or mental health purposes
- Any current or past diagnosis and/or significant symptoms of psychosis-related disorders (schizophrenia, schizoaffective disorder), bipolar disorder, autism spectrum disorder, personality disorder
- Current diagnosis and/or significant symptoms of post-traumatic stress disorder (PTSD), eating disorder, substance use disorder, obsessive-compulsive disorder (OCD)
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- Currently participating in other therapeutic trials
- Currently in a legal process regarding disability benefits.
- Currently pregnant
- Started an antidepressant or changed dose in the past 6 weeks
- Inability to reliably complete tasks related to the study
- Any impairment, activity or situation that in the judgement of the Study Coordinator or Principal Investigator would prevent satisfactory completion of the study protocol. This includes unreliable, or inconsistent pain scores as deemed by the principal investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Reprocessing Therapy for Chronic Widespread Pain - A Randomized Multiple-baseline SCED Trial
Chronic Widespread Pain (CWP) is classified as a Chronic Primary Pain syndrome in the ICD-11 and is considered a major type of nociplastic pain with an estimated prevalence of up to 8-10% in the general population. Many CWP patients experience inadequate treatment and poor symptom management, leaving them prone to disability. Pain Reprocessing Therapy (PRT) is a novel therapy specifically designed to target nociplastic pain with a combination of cognitive, exposure-based, and interoceptively-focused psychotherapy techniques. A recent clinical trial indicated large effects of PRT for chronic back pain, but no studies have yet investigated PRT for CWP. Furthermore, there is little knowledge about how pain and other outcomes change during PRT intervention (between baseline and post-intervention timepoints).
The investigators will use a Single-Case Experimental Design (SCED) to investigate PRT for CWP. Primary outcomes include pain collected at the baseline visit and the post-intervention visit, and Ecological Momentary Assessment (EMA) outcomes including pain, mood, sleep, behavior, and medication, collected up to 4 times per day during the baseline and PRT (intervention) period. Secondary outcomes include a range of state-based outcomes collected at the baseline visit and the post-intervention visit.
- Conditions
- Pain, Chronic Widespread Pain, Chronic Pain, Fibromyalgia
- Being tested
- Pain Reprocessing Therapy
- Keywords
- Pain, Chronic widespread pain, Fibromyalgia, Pain reprocessing therapy, SCED, Single-case experimental design
- Medical subject headings
- Pain, Chronic Pain, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Reprocessing TherapyBehavioural
Each PRT session will take 45-60 minutes and includes psychoeducation about the association between pain and the brain, mindfulness, and exposure- and acceptance-based concepts. Through PRT, participants will learn about how pain can emerge from 'stuck patterns' in neural circuits in the brain. Through reflections of their own pain experiences, the patient explores evidence for whether this applies to their own pain. Patients will acquire corrective experiences in which their brain "learns" not to respond with pain ("false alarm") in situations that are safe. One central reprocessing exercise is 'somatic tracking', in which participants explore their pain sensations in a context of safety. This includes interoceptive exposures and situational exposures to activities they fear will trigger pain. Exploring these sensations and situations through a lens of safety and curiosity allows the participants to reinterpret bodily sensations previously associated with threat or pain, as safe.
| Study group | Role | What they receive |
|---|---|---|
| Pain Reprocessing Therapy | Experimental | After a baseline period of 6-14 days (pseudorandomized duration), patients will undergo 9 interventional sessions over a span of 4-6 weeks. This includes an initial consultation with a medical doctor in order to confirm that clinical inclusion criteria are met and exclude potential structural (nociceptive or neuropathic) causes of pain. After this consultation, participants undergo 8 PRT sessions with a clinical psychologist trained in PRT. Receives: Behavioral: Pain Reprocessing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ecological Momentary Assessment (EMA) questionnaire
Participants will answer EMA questions 4 times per day (morning, noon/early afternoon, afternoon, and evening) during the baseline period (6-14 days, pseudorandomized) and throughout the intervention period (4-8 weeks). Every questionnaire includes questions about current activity, affect, mood, pain, and social connectedness. The morning questionnaire includes an additional question about sleep quality, and the evening questionnaire includes additional questions about rest, feeling present, medicine use, pain-related worrying, overall pain intensity, perceived ability to manage pain, adjustment of daily activities due to pain, and avoidance of pain throughout the day. Additionaly, each individual answer a personal targeted question (evening only) formulated in collaboration with the patient with at baseline. While most questions are rated using Visual Analog Scale (VAS), some use open text (current activity, medicine), yes/no (current pain), multiple choice (pain location, rest).
Measured: During baseline (6-14 days, pseudorandomized) and throughout the intervention period (4-6 weeks)
Change from baseline in the Brief Pain Inventory (BPI) - Pain severity
The Brief Pain Inventory is a 17-items questionnaire that assesses pain severity (0-10 Numeric Rating Scale, NRS), pain interference with activities (0-10 NRS), medication used for pain, and a body map in which the participant may mark body areas where pain is present.
Measured: From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Brief Pain Inventory (BPI) - Pain interference
The Brief Pain Inventory is a 17-items questionnaire that assesses pain severity (0-10 Numeric Rating Scale, NRS), pain interference with activities (0-10 NRS), medication used for pain, and a body map in which the participant may mark body areas where pain is present.
Measured: From enrolment to the end of treatment at 4-6 weeks
Secondary outcomes (14)
Change from baseline in the Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) is a 13 item scale that measures catastrophic thinking related to pain. The questionnaire is rated using a 0-4 Likert scale and is scored using the three subscales rumination, magnification, and helplessness, or a total sum score for all items.
Measured: From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Pain Coping Questionnaire - short form
The Pain Coping Questionnaire (short form) is a 16-item questionnaire that is rated using a 1-5 Likert scale.
Measured: From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the State-Trait Anxiety Inventory (State questionnaire only)
The State-Trait Anxiety Inventory (STAI) consists of two similar 20-item questionnaires that measures trait-based anxiety and state-based (situational) anxiety, rated on a 1-4 Likert scale. Only the part measuring state (situational) anxiety will be used.
Measured: From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Generalized Anxiety Disorder Assessment (GAD-7)
The GAD-7 is a 7-item scale that measures generalized anxiety, and is routinely used as a screening tool for generalized anxiety disorder. The questionnaire uses a 0-3 Likert scale.
Measured: From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Becks Depression Inventory II (BDI-2)
The BDI-2 is a 21-item questionnaire measuring depression, using a 0-3 Likert scale
Measured: From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS)
The SHAPS measures the capacity to experience pleasure (hedonic tone) and uses a 1-4 Likert scale. A higher score indicates higher level of anhedonia.
Measured: From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Life Satisfaction Questionnaire (LISAT-11)
The LISAT-11 is an 11-item scale measuring satisfaction with different aspects of life and uses a 1-6 Numeric Rating Scale.
Measured: From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the PROMIS-29
The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a 29-item questionnaire designed for chronic pain patients, that measures physical function, anxiety, depression, fatigue, sleep problems, ability to participate in social activities, pain interference in activities, and pain intensity.
Measured: From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Multidimensional Assessment of Interoceptive Awareness 2 brief version (brief MAIA-2)
The brief MAIA-2 is a 24-item scale measures different aspects of interoceptive awareness using a 0-5 Numeric Rating Scale.
Measured: From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Perceived Stress Scale brief version
The Perceived Stress Scale (brief version) is a 10-item scale measuring thoughts and feelings about stress using a 0-4 Likert Scale.
Measured: From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Stress Mindset Measure (SMM)
The SMM is a 8-item scale measuring the extent to which an individual adopts a mindset that the effects of stress are enhancing or debilitating. It uses a 0-4 Likert Scale.
Measured: From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the brief Existential Isolation Scale
The EIS is a 6-item scale that measures social isolation as an existential experience, and uses a 0-9 Numeric Rating Scale.
Measured: From enrolment to the end of treatment at 4-6 weeks
Change in the Working Alliance Inventory (WAI) throughout the course of Pain Reprocessing Therapy
The WAI is a 12-item questionnaire measuring the therapeutic alliance between a psychotherapist and a client, and is answered by the client. The WAI uses a 1-7 Likert Scale.
Measured: Up to 6 hours after every 2 PRT sessions (assessed until the last PRT session, up to 4-6 weeks after enrolment)
Life Orientation Test (LOT-R)
The revised Life Orientation Test (LOT-R) is a 10-item questionnaire measuring dispositional optimism and pessimism, and uses a 0-4 Likert scale, in which higher scores indicate higher dispositional optimism and lower dispositional pessimism.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start7 May 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- The investigators will use a randomized multiple baselines Single-case experimental design. This is a within-subjects design commonly used in SCED studies, in which each participant has a baseline period with a randomized duration (i.e. different participants are assessed for a different number of days prior to treatment onset).
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kristiania University College
- Responsible party
- Principal investigator, Dan-Mikael Ellingsen, Oslo University Hospital
- Investigators
- Dan-Mikael Ellingsen, PhD, Principal investigator, Oslo University Hospital: Oslo Universitetssykehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050758
- Sponsor's protocol ID
- 2025032
- Other IDs
- 2025032
- Acronym
- FOKUS
- Status last verified
- Sep 2025
- First submitted
- 12 Jun 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data from participants who agree to have their anonymized data shared for research purposes will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Reprocessing Therapy for Chronic Widespread Pain - A Randomized Multiple-baseline SCED Trial
- ClinicalTrials.gov ID
- NCT07050758
- Acronym / sponsor ID
- FOKUS / 2025032
- Conditions
- Pain, Chronic Widespread Pain, Chronic Pain, Fibromyalgia
- Keywords
- Pain, Chronic widespread pain, Fibromyalgia, Pain reprocessing therapy, SCED, Single-case experimental design
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Kristiania University College
- Study start
- 7 May 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 3 Jul 2025 (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.
Chronic Widespread Pain (CWP) is classified as a Chronic Primary Pain syndrome in the ICD-11 and is considered a major type of nociplastic pain with an estimated prevalence of up to 8-10% in the general population. Many CWP patients experience inadequate treatment and poor symptom management, leaving them prone to disability. Pain Reprocessing Therapy (PRT) is a novel therapy specifically designed to target nociplastic pain with a combination of cognitive, exposure-based, and interoceptively-focused psychotherapy techniques. A recent clinical trial indicated large effects of PRT for chronic back pain, but no studies have yet investigated PRT for CWP. Furthermore, there is little knowledge about how pain and other outcomes change during PRT intervention (between baseline and post-intervention timepoints).
The investigators will use a Single-Case Experimental Design (SCED) to investigate PRT for CWP. Primary outcomes include pain collected at the baseline visit and the post-intervention visit, and Ecological Momentary Assessment (EMA) outcomes including pain, mood, sleep, behavior, and medication, collected up to 4 times per day during the baseline and PRT (intervention) period. Secondary outcomes include a range of state-based outcomes collected at the baseline visit and the post-intervention visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The investigators will use a randomized multiple baselines Single-case experimental design. This is a within-subjects design commonly used in SCED studies, in which each participant has a baseline period with a randomized duration (i.e. different participants are assessed for a different number of days prior to treatment onset).
| Arm | Type | Receives |
|---|---|---|
| Pain Reprocessing Therapy | Experimental | Behavioral: Pain Reprocessing TherapyAfter a baseline period of 6-14 days (pseudorandomized duration), patients will undergo 9 interventional sessions over a span of 4-6 weeks. This includes an initial consultation with a medical doctor in order to confirm that clinical inclusion criteria are met and exclude potential structural (nociceptive or neuropathic) causes of pain. After this consultation, participants undergo 8 PRT sessions with a clinical psychologist trained in PRT. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-65 (inclusive)
- Qualifying for Chronic Widespread Pain (CWP), as described in ICD-11 (an existing diagnosis of fibromyalgia qualifies for CWP)
- Baseline pain with an average intensity of at least 4/10 that has lasted for 3 months or longer
- If on medication that could potentially interfere with study participation or outcomes as evaluated by the study physician, stable doses of medication for 6 weeks prior to entering the study and during participation
- Living in Norway
Key exclusion criteria (12 listed)
- Current comorbid acute pain condition (pain from acute illness, injury, infection, or similar in the past 3 weeks)
- Beck Depression Index (BDI) score more than 30
- Clinical high risk for suicidality (BDI short form item 7 on suicidality rated ≥ 2, or modaterate/high scores for suicidality in M.I.N.I. interview)
- Current psychological therapy for pain or mental health purposes
- Any current or past diagnosis and/or significant symptoms of psychosis-related disorders (schizophrenia, schizoaffective disorder), bipolar disorder, autism spectrum disorder, personality disorder
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 |
|---|---|---|
| Pain Reprocessing TherapyEach PRT session will take 45-60 minutes and includes psychoeducation about the association between pain and the brain, mindfulness, and exposure- and acceptance-based concepts. Through PRT, participants will learn about how pain can emerge from 'stuck patterns' in neural circuits in the brain. Through reflections of their own pain experiences, the patient explores evidence for whether this applies to their own pain. Patients will acquire corrective experiences in which their brain "learns" not to respond with pain ("false alarm") in situations that are safe. One central reprocessing exercise is 'somatic tracking', in which participants explore their pain sensations in a context of safety. This includes interoceptive exposures and situational exposures to activities they fear will trigger pain. Exploring these sensations and situations through a lens of safety and curiosity allows the participants to reinterpret bodily sensations previously associated with threat or pain, as safe. | Behavioural | Pain Reprocessing Therapy |
Primary outcome
Ecological Momentary Assessment (EMA) questionnaire
Time frame: During baseline (6-14 days, pseudorandomized) and throughout the intervention period (4-6 weeks)
Participants will answer EMA questions 4 times per day (morning, noon/early afternoon, afternoon, and evening) during the baseline period (6-14 days, pseudorandomized) and throughout the intervention period (4-8 weeks). Every questionnaire includes questions about current activity, affect, mood, pain, and social connectedness. The morning questionnaire includes an additional question about sleep quality, and the evening questionnaire includes additional questions about rest, feeling present, medicine use, pain-related worrying, overall pain intensity, perceived ability to manage pain, adjustment of daily activities due to pain, and avoidance of pain throughout the day. Additionaly, each individual answer a personal targeted question (evening only) formulated in collaboration with the patient with at baseline. While most questions are rated using Visual Analog Scale (VAS), some use open text (current activity, medicine), yes/no (current pain), multiple choice (pain location, rest).
Change from baseline in the Brief Pain Inventory (BPI) - Pain severity
Time frame: From enrolment to the end of treatment at 4-6 weeks
The Brief Pain Inventory is a 17-items questionnaire that assesses pain severity (0-10 Numeric Rating Scale, NRS), pain interference with activities (0-10 NRS), medication used for pain, and a body map in which the participant may mark body areas where pain is present.
Change from baseline in the Brief Pain Inventory (BPI) - Pain interference
Time frame: From enrolment to the end of treatment at 4-6 weeks
The Brief Pain Inventory is a 17-items questionnaire that assesses pain severity (0-10 Numeric Rating Scale, NRS), pain interference with activities (0-10 NRS), medication used for pain, and a body map in which the participant may mark body areas where pain is present.
14 secondary outcomes
Change from baseline in the Pain Catastrophizing Scale (PCS)
Time frame: From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Pain Coping Questionnaire - short form
Time frame: From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the State-Trait Anxiety Inventory (State questionnaire only)
Time frame: From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Generalized Anxiety Disorder Assessment (GAD-7)
Time frame: From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Becks Depression Inventory II (BDI-2)
Time frame: From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS)
Time frame: From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Life Satisfaction Questionnaire (LISAT-11)
Time frame: From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the PROMIS-29
Time frame: From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Multidimensional Assessment of Interoceptive Awareness 2 brief version (brief MAIA-2)
Time frame: From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Perceived Stress Scale brief version
Time frame: From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the Stress Mindset Measure (SMM)
Time frame: From enrolment to the end of treatment at 4-6 weeks
Change from baseline in the brief Existential Isolation Scale
Time frame: From enrolment to the end of treatment at 4-6 weeks
Change in the Working Alliance Inventory (WAI) throughout the course of Pain Reprocessing Therapy
Time frame: Up to 6 hours after every 2 PRT sessions (assessed until the last PRT session, up to 4-6 weeks after enrolment)
Life Orientation Test (LOT-R)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: Yes. Individual participant data from participants who agree to have their anonymized data shared for research purposes will be made available.
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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.
Dan-Mikael Ellingsen, PhD principal investigator
Oslo University Hospital: Oslo Universitetssykehus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Reprocessing Therapy in people with Pain and Chronic Widespread Pain, run by Oslo University Hospital at 1 site in Norway.
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 8 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 10 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 Norway. 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?
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?
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?
Ecological Momentary Assessment (EMA) questionnaire (time frame: During baseline (6-14 days, pseudorandomized) and throughout the intervention period (4-6 weeks)). 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?
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 Sep 2025.