Carpal Tunnel SyndromeNCT05915611
Combined Physical and Psychological Intervention in Carpal Tunnel Syndrome Patients With Nociplastic Pain
A study testing Standardized Carpal Tunnel Syndrome Rehabilitation, Psychologically Informed Pain-Management Program and Attention-Matched Health Education in people with Carpal Tunnel Syndrome and Pain, Chronic, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
This randomized, assessor-blinded, parallel-group trial evaluated the effectiveness of adding a psychologically informed pain-management intervention to standardized physical rehabilitation in adults with electrodiagnostically confirmed carpal tunnel syndrome and coexisting mixed neuropathic-nociplastic pain features. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Pain, Chronic
- What is being tested?
- Standardized Carpal Tunnel Syndrome Rehabilitation, Psychologically Informed Pain-Management Program and Attention-Matched Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jul 2023to 22 Jun 2026
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 25-65 years with unilateral or bilateral carpal tunnel syndrome confirmed by compatible clinical findings and electrodiagnostic evidence of median neuropathy at the wrist.
- CTS-related symptoms present for ≥3 months.
- Mild-to-moderate CTS suitable for nonsurgical management.
- Coexisting mixed neuropathic-nociplastic pain features according to a CTS-adapted IASP-aligned clinical algorithm.
Who cannot join
- Previous carpal tunnel release surgery on the study side.
- Severe CTS with marked thenar weakness/atrophy, severe axonal loss, or other findings requiring prompt surgical evaluation.
- Cervical radiculopathy or cervical myelopathy judged to better explain the upper-extremity symptoms.
- Proximal median neuropathy or other clinically important peripheral entrapment neuropathy.
- Generalized polyneuropathy.
- Major shoulder, elbow, wrist, or hand disorder considered the dominant cause of symptoms or disability.
Show all 10Show fewer
- Recent corticosteroid injection or other invasive CTS treatment within a prespecified washout period.
- Concurrent structured CTS rehabilitation outside the study protocol.
- Previous participation in a structured psychological pain-management program during the recent prespecified period.
- Medical, cognitive, or communication limitations preventing safe participation or valid completion of study procedures.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
About this study
Official title: Effectiveness of a Combined Physical and Psychologically Informed Intervention in Adults With Carpal Tunnel Syndrome and Coexisting Nociplastic Pain Features: A Randomized Controlled Trial
This randomized, assessor-blinded, parallel-group trial evaluated the effectiveness of adding a psychologically informed pain-management intervention to standardized physical rehabilitation in adults with electrodiagnostically confirmed carpal tunnel syndrome and coexisting mixed neuropathic-nociplastic pain features. A total of 178 participants were randomized in a 1:1 ratio. The active treatment period lasted 6 weeks, with follow-up through 12 weeks after randomization. The primary outcome was the Boston Carpal Tunnel Questionnaire-Symptom Severity Scale at 6 weeks.
Read the detailed description
This randomized, assessor-blinded, parallel-group trial evaluate whether adding a psychologically informed pain-management intervention to standardized physical rehabilitation improves carpal tunnel syndrome symptoms in adults with electrodiagnostically confirmed carpal tunnel syndrome and coexisting nociplastic pain features. A total of 178 participants will be randomized in a 1:1 ratio to receive either standardized physical rehabilitation plus a psychologically informed pain-management program or the same standardized physical rehabilitation plus attention-matched health education. The active treatment period will last 6 weeks, with follow-up at 12 weeks after randomization. The primary outcome will be the Boston Carpal Tunnel Questionnaire-Symptom Severity Scale at 6 weeks. Secondary outcomes will assess pain intensity, hand function, pain catastrophizing, kinesiophobia, upper-extremity disability, patient-perceived improvement, pain-processing characteristics, grip strength, and median-nerve electrophysiological measures.
- Conditions
- Carpal Tunnel Syndrome, Pain, Chronic
- Being tested
- Standardized Carpal Tunnel Syndrome Rehabilitation, Psychologically Informed Pain-Management Program, Attention-Matched Health Education
- Medical subject headings
- Carpal Tunnel Syndrome, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Carpal Tunnel Syndrome RehabilitationOther
Participants will receive a standardized 6-week physical rehabilitation program for carpal tunnel syndrome. Treatment will include night-time neutral-position wrist splinting, flexor-tendon gliding exercises, median-nerve neurodynamic exercises, education regarding activities that provoke symptoms, and a standardized home-exercise program. Supervised physical therapy will be provided twice weekly for 6 weeks, for a total of 12 supervised sessions. Participants will be instructed to perform the prescribed home exercises between supervised sessions.
Psychologically Informed Pain-Management ProgramBehavioural
Participants will receive six individual psychologically informed pain-management sessions, approximately 40-45 minutes each, delivered once weekly over 6 weeks. The program will include pain neuroscience education, identification and modification of maladaptive pain beliefs, cognitive restructuring, strategies to reduce pain catastrophizing and fear of movement, graded exposure to feared upper-extremity activities, activity pacing, coping and self-management strategies, and relapse-prevention planning. The intervention will be delivered in addition to standardized CTS rehabilitation.
Attention-Matched Health EducationBehavioural
Participants will receive six individual health-education sessions, approximately 40-45 minutes each, delivered once weekly over 6 weeks. Sessions will be matched approximately to the experimental psychological intervention for therapist contact, frequency, and duration. Content will include general information regarding healthy lifestyle, sleep hygiene, physical activity, and general hand health. The sessions will not include pain neuroscience education, cognitive restructuring, pain-catastrophizing management, graded exposure, or other specific psychologically informed pain-management strategies.
| Study group | Role | What they receive |
|---|---|---|
| Standardized CTS Rehabilitation Plus Psychologically Informed Pain Management | Experimental | Participants will receive standardized physical rehabilitation for carpal tunnel syndrome together with a structured psychologically informed pain-management program for 6 weeks. Standardized rehabilitation will include night-time neutral-position wrist splinting, supervised flexor-tendon gliding and median-nerve neurodynamic exercises, education regarding symptom-provoking activities, and a standardized home-exercise program. Participants will additionally receive six individual psychologically informed pain-management sessions, approximately 40-45 minutes each, delivered once weekly. Receives: Other: Standardized Carpal Tunnel Syndrome Rehabilitation; Behavioral: Psychologically Informed Pain-Management Program |
| Standardized CTS Rehabilitation Plus Attention-Matched Health Education | Active comparator | Participants will receive the same standardized physical rehabilitation and home-exercise program as the experimental group for 6 weeks. In addition, participants will receive six individual attention-matched health-education sessions, approximately 40-45 minutes each, delivered once weekly. The health-education sessions will address general healthy lifestyle, sleep hygiene, physical activity, and hand health without including the specific psychologically informed pain-management components provided to the experimental group. Receives: Other: Standardized Carpal Tunnel Syndrome Rehabilitation; Behavioral: Attention-Matched Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)
Carpal tunnel syndrome symptom severity will be assessed using the 11-item Symptom Severity Scale of the Boston Carpal Tunnel Questionnaire. Each item is scored from 1 to 5, and the total scale score is calculated as the mean of the completed items, with higher scores indicating greater symptom severity. The primary endpoint is the BCTQ-SSS score at 6 weeks after randomization.
Measured: Baseline and 6 weeks after randomization.
Secondary outcomes (9)
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS) Score at 12 Weeks
Carpal tunnel syndrome symptom severity will be assessed using the 11-item Symptom Severity Scale of the Boston Carpal Tunnel Questionnaire (BCTQ-SSS). Each item is scored from 1 to 5. The scale score is calculated as the mean of the completed items and ranges from 1 to 5, with higher scores indicating greater symptom severity. The 12-week assessment will evaluate maintenance of the treatment effect after completion of the 6-week intervention period.
Measured: Baseline and 12 weeks after randomization.
Pain catastrophizing using the Pain Catastrophizing Scale (PCS)
Pain-related catastrophic thinking will be assessed using the 13-item Pain Catastrophizing Scale (PCS), which evaluates rumination, magnification, and helplessness related to pain. Each item is scored from 0 to 4, producing a total score ranging from 0 to 52. Higher scores indicate greater pain catastrophizing.
Measured: Baseline, 3 weeks, 6 weeks, and 12 weeks after randomization.
Fear of movement using the Tampa Scale for Kinesiophobia (TSK)
Fear of movement and pain-related movement avoidance will be assessed using the 11-item Tampa Scale for Kinesiophobia (TSK-11). Each item is scored on a 4-point scale, producing a total score ranging from 11 to 44. Higher scores indicate greater kinesiophobia.
Measured: Baseline, 3 weeks, 6 weeks, and 12 weeks after randomization.
Grip strength measured using a hand dynamometer
Maximum voluntary grip strength of the study hand will be measured using a calibrated hand dynamometer in a standardized seated position. Three trials will be performed with a prespecified rest interval between trials. The mean of the three trials, expressed in kilograms, will be used for analysis. Higher values indicate greater grip strength.
Measured: Baseline, 6 weeks, and 12 weeks after randomization.
Numeric Pain Rating Scale for CTS-Related Hand and Wrist Pain
Description:
Average carpal tunnel syndrome-related hand and wrist pain during usual activities over the previous 7 days will be assessed using an 11-point Numeric Pain Rating Scale (NPRS), ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: Baseline, 6 weeks, and 12 weeks after randomization.
Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS)
Carpal tunnel syndrome-related functional limitation will be assessed using the 8-item Functional Status Scale of the Boston Carpal Tunnel Questionnaire (BCTQ-FSS). Each item is scored from 1 to 5. The scale score is calculated as the mean of the completed items and ranges from 1 to 5, with higher scores indicating greater difficulty performing activities commonly affected by carpal tunnel syndrome.
Measured: Baseline, 6 weeks, and 12 weeks after randomization.
Disabilities of the Arm, Shoulder and Hand (DASH) Score
Upper-extremity symptoms and disability will be assessed using the 30-item Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The DASH score ranges from 0 to 100, with higher scores indicating greater upper-extremity disability and symptom severity.
Measured: Baseline, 6 weeks, and 12 weeks after randomization.
Central Sensitization Inventory (CSI)
Symptoms associated with central sensitization-related presentations will be assessed using Part A of the Central Sensitization Inventory (CSI). The 25 items are scored from 0 to 4 and summed to produce a total score ranging from 0 to 100. Higher scores indicate greater self-reported symptom burden associated with central sensitization-related presentations. The CSI will be used as a symptom-burden and phenotyping measure and not as a stand-alone diagnostic test for nociplastic pain.
Measured: Baseline, 6 weeks, and 12 weeks after randomization.
Patient Global Impression of Change (PGIC)
Participant-perceived overall change in carpal tunnel syndrome symptoms and functional status since the beginning of treatment will be assessed using the Patient Global Impression of Change (PGIC). Participants will rate their overall change using a 7-category scale ranging from "very much improved" to "very much worse." Responses will be analyzed as an ordinal measure of patient-perceived improvement or deterioration.
Measured: 6 weeks and 12 weeks after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start2 Jul 2023
- Primary completion11 May 2026
- Study completion22 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Amal Fawzy, Ph.d, Study director, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915611
- Sponsor's protocol ID
- 012/CTS/120002023
- Status last verified
- Oct 2026
- First submitted
- 14 Jun 2023
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Combined Physical and Psychologically Informed Intervention in Adults With Carpal Tunnel Syndrome and Coexisting Nociplastic Pain Features: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05915611
- Acronym / sponsor ID
- 012/CTS/120002023
- Conditions
- Carpal Tunnel Syndrome, Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 2 Jul 2023 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 22 Jun 2026 (actual)
- First posted
- 23 Jun 2023 (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.
This randomized, assessor-blinded, parallel-group trial evaluated the effectiveness of adding a psychologically informed pain-management intervention to standardized physical rehabilitation in adults with electrodiagnostically confirmed carpal tunnel syndrome and coexisting mixed neuropathic-nociplastic pain features. A total of 178 participants were randomized in a 1:1 ratio. The active treatment period lasted 6 weeks, with follow-up through 12 weeks after randomization. The primary outcome was the Boston Carpal Tunnel Questionnaire-Symptom Severity Scale at 6 weeks.
Detailed description
This randomized, assessor-blinded, parallel-group trial evaluate whether adding a psychologically informed pain-management intervention to standardized physical rehabilitation improves carpal tunnel syndrome symptoms in adults with electrodiagnostically confirmed carpal tunnel syndrome and coexisting nociplastic pain features. A total of 178 participants will be randomized in a 1:1 ratio to receive either standardized physical rehabilitation plus a psychologically informed pain-management program or the same standardized physical rehabilitation plus attention-matched health education. The active treatment period will last 6 weeks, with follow-up at 12 weeks after randomization. The primary outcome will be the Boston Carpal Tunnel Questionnaire-Symptom Severity Scale at 6 weeks. Secondary outcomes will assess pain intensity, hand function, pain catastrophizing, kinesiophobia, upper-extremity disability, patient-perceived improvement, pain-processing characteristics, grip strength, and median-nerve electrophysiological measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized CTS Rehabilitation Plus Psychologically Informed Pain Management | Experimental | Other: Standardized Carpal Tunnel Syndrome Rehabilitation, Behavioral: Psychologically Informed Pain-Management ProgramParticipants will receive standardized physical rehabilitation for carpal tunnel syndrome together with a structured psychologically informed pain-management program for 6 weeks. Standardized rehabilitation will include night-time neutral-position wrist splinting, supervised flexor-tendon gliding and median-nerve neurodynamic exercises, education regarding symptom-provoking activities, and a standardized home-exercise program. Participants will additionally receive six individual psychologically informed pain-management sessions, approximately 40-45 minutes each, delivered once weekly. |
| Standardized CTS Rehabilitation Plus Attention-Matched Health Education | Active comparator | Other: Standardized Carpal Tunnel Syndrome Rehabilitation, Behavioral: Attention-Matched Health EducationParticipants will receive the same standardized physical rehabilitation and home-exercise program as the experimental group for 6 weeks. In addition, participants will receive six individual attention-matched health-education sessions, approximately 40-45 minutes each, delivered once weekly. The health-education sessions will address general healthy lifestyle, sleep hygiene, physical activity, and hand health without including the specific psychologically informed pain-management components provided to the experimental group. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 25-65 years with unilateral or bilateral carpal tunnel syndrome confirmed by compatible clinical findings and electrodiagnostic evidence of median neuropathy at the wrist.
- CTS-related symptoms present for ≥3 months.
- Mild-to-moderate CTS suitable for nonsurgical management.
- Coexisting mixed neuropathic-nociplastic pain features according to a CTS-adapted IASP-aligned clinical algorithm.
Key exclusion criteria (10 listed)
- Previous carpal tunnel release surgery on the study side.
- Severe CTS with marked thenar weakness/atrophy, severe axonal loss, or other findings requiring prompt surgical evaluation.
- Cervical radiculopathy or cervical myelopathy judged to better explain the upper-extremity symptoms.
- Proximal median neuropathy or other clinically important peripheral entrapment neuropathy.
- Generalized polyneuropathy.
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 |
|---|---|---|
| Standardized Carpal Tunnel Syndrome RehabilitationParticipants will receive a standardized 6-week physical rehabilitation program for carpal tunnel syndrome. Treatment will include night-time neutral-position wrist splinting, flexor-tendon gliding exercises, median-nerve neurodynamic exercises, education regarding activities that provoke symptoms, and a standardized home-exercise program. Supervised physical therapy will be provided twice weekly for 6 weeks, for a total of 12 supervised sessions. Participants will be instructed to perform the prescribed home exercises between supervised sessions. | Other | Standardized CTS Rehabilitation Plus Attention-Matched Health Education, Standardized CTS Rehabilitation Plus Psychologically Informed Pain Management |
| Psychologically Informed Pain-Management ProgramParticipants will receive six individual psychologically informed pain-management sessions, approximately 40-45 minutes each, delivered once weekly over 6 weeks. The program will include pain neuroscience education, identification and modification of maladaptive pain beliefs, cognitive restructuring, strategies to reduce pain catastrophizing and fear of movement, graded exposure to feared upper-extremity activities, activity pacing, coping and self-management strategies, and relapse-prevention planning. The intervention will be delivered in addition to standardized CTS rehabilitation. | Behavioural | Standardized CTS Rehabilitation Plus Psychologically Informed Pain Management |
| Attention-Matched Health EducationParticipants will receive six individual health-education sessions, approximately 40-45 minutes each, delivered once weekly over 6 weeks. Sessions will be matched approximately to the experimental psychological intervention for therapist contact, frequency, and duration. Content will include general information regarding healthy lifestyle, sleep hygiene, physical activity, and general hand health. The sessions will not include pain neuroscience education, cognitive restructuring, pain-catastrophizing management, graded exposure, or other specific psychologically informed pain-management strategies. | Behavioural | Standardized CTS Rehabilitation Plus Attention-Matched Health Education |
Primary outcome
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)
Time frame: Baseline and 6 weeks after randomization.
Carpal tunnel syndrome symptom severity will be assessed using the 11-item Symptom Severity Scale of the Boston Carpal Tunnel Questionnaire. Each item is scored from 1 to 5, and the total scale score is calculated as the mean of the completed items, with higher scores indicating greater symptom severity. The primary endpoint is the BCTQ-SSS score at 6 weeks after randomization.
9 secondary outcomes
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS) Score at 12 Weeks
Time frame: Baseline and 12 weeks after randomization.
Pain catastrophizing using the Pain Catastrophizing Scale (PCS)
Time frame: Baseline, 3 weeks, 6 weeks, and 12 weeks after randomization.
Fear of movement using the Tampa Scale for Kinesiophobia (TSK)
Time frame: Baseline, 3 weeks, 6 weeks, and 12 weeks after randomization.
Grip strength measured using a hand dynamometer
Time frame: Baseline, 6 weeks, and 12 weeks after randomization.
Numeric Pain Rating Scale for CTS-Related Hand and Wrist Pain
Time frame: Baseline, 6 weeks, and 12 weeks after randomization.
Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS)
Time frame: Baseline, 6 weeks, and 12 weeks after randomization.
Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time frame: Baseline, 6 weeks, and 12 weeks after randomization.
Central Sensitization Inventory (CSI)
Time frame: Baseline, 6 weeks, and 12 weeks after randomization.
Patient Global Impression of Change (PGIC)
Time frame: 6 weeks and 12 weeks after randomization.
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 9 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Carpal Tunnel Syndrome
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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.
Amal Fawzy, Ph.d study director
Faculty of Physical Therapy, Ahram Canadian 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 Standardized Carpal Tunnel Syndrome Rehabilitation, Psychologically Informed Pain-Management Program and Attention-Matched Health Education in people with Carpal Tunnel Syndrome and Pain, Chronic, run by Ahram Canadian University at 1 site in Egypt.
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 4 inclusion and 10 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 9 Oct 2026. 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 Egypt. 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?
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS) (time frame: Baseline and 6 weeks after randomization.). 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 9 Oct 2026.