Functional ConstipationPhase 2NCT05760313
A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide
A Phase 2 study testing Linaclotide in people with Functional Constipation, run by AbbVie at 38 sites in 7 countries.
Trial summary
Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility. Currently, there are no pharmacological therapies approved for the treatment of FC. Read more about this study
- Who is it for?
- Ages 6 to 23 months
- Conditions the study is for
- Functional Constipation
- What is being tested?
- Linaclotide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 38 sitesin 7 countries
- Study dates
- 27 Apr 2023to 9 Jun 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Individuals must be 6 months to less than 1 year and 11 months old, at the time the legally authorized representative (LAR)/parent/guardian signs the informed consent in alignment with local requirements.
- The LAR/parent/guardian who will be completing the electronic diary (eDiary) is able to read and understand the assessments in the eDiary device and must undergo training.
- Participant meets Rome IV criteria for functional constipation (FC): for at least 1 month before Screening (Visit 1), the participant must meet 2 or more of the following:
- 2 or fewer defecations per week (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours)
- History of excessive stool retention
- History of painful or hard bowel movements (BMs)
Show all 9Show fewer
- History of large-diameter stools
- Presence of a large fecal mass in the rectum
- LAR/Parent/Guardian is willing to discontinue any laxatives used before the Preintervention Visit in favor of the protocol-permitted rescue medicine.
Who cannot join
- Participant has conditions that could interfere with drug absorption, including, but not limited to, short bowel syndrome.
- History of clinically significant medical conditions or any other reason that the investigator determines would interfere with the individual's participation in this study or would make the participant an unsuitable candidate to receive study drug.
- Participant has history of:
- Celiac disease, or positive serological test for celiac disease or the condition is suspected but has not been ruled out by endoscopic biopsy
- Cystic fibrosis
- Hypothyroidism that is untreated or treated with thyroid hormone at a dose that has not been stable for at least 3 months prior to Screening (Visit 1)
Show all 15Show fewer
- Down's syndrome or any other chromosomal disorder
- Active anal fissure (investigator has confirmed an active anal fissure and participant reports known anal fissure symptoms [i.e., streaks of blood on the stool or on diaper or toilet paper and pain/crying with bowel movement within 2 weeks prior to Screening]). (Note: Anal fissures that have resolved at least 2 weeks prior to screening would not be exclusionary). However, if in the investigator's opinion, an anal fissure(s) may be the primary cause of participant's Rome IV FC criteria, the subject would not be eligible to participate in the study.
- Anatomic malformations (e.g., imperforate anus, anal stenosis, anterior displaced anus)
- Intestinal nerve or muscle disorders (e.g., Hirschprung disease, visceral myopathies, visceral neuropathies)
- Neuropathic conditions (e.g., spinal cord abnormalities, neurofibromatosis, tethered cord, spinal cord trauma)
- Lead toxicity, hypercalcemia
- Inflammatory bowel disease
- Lactose intolerance that is associated with symptoms which could confound the assessments in this study
- History of cancer. (Note: Participants with a history of cancer are allowed provided that the malignancy has been in a complete remission before enrollment/randomization (Visit 3). A complete remission is defined as the disappearance of all signs of cancer in response to treatment)
Trial locations and contacts
38 sites in 7 countries.
38 sites in 7 countries
United States18 sites
Advanced Research Center /ID# 248763
Anaheim, California, 92805
Coastal Pediatric Research - West Ashley B /ID# 248693
Charleston, South Carolina, 29414
Kindred Medical Institute - Corona /ID# 251535
Corona, California, 92879-3104
Prohealth Research Center /ID# 248696
Doral, Florida, 33166
Michigan Center of Medical Research /ID# 253536
Farmington Hills, Michigan, 48334
Velocity Clinical Research- Hastings Nebraska /ID# 260932
Hastings, Nebraska, 68901-2640
HealthStar Research of Hot Springs PLLC /ID# 251553
Hot Springs, Arkansas, 71913
Houston Clinical Research Associates /ID# 261571
Houston, Texas, 77090-2633
Velocity Clinical Research - Lafayette /ID# 263873
Lafayette, Louisiana, 70508
Velocity Clinical Research Macon /ID# 263959
Macon, Georgia, 31210-6583
Prime Clinical Research - Mansfield - East Broad Street /ID# 262947
Mansfield, Texas, 76063
South Miami Medical & Research Group Inc. /ID# 248765
Miami, Florida, 33155
Valencia Medical & Research Center /ID# 251533
Miami, Florida, 33165
Frederick County Pediatrics /ID# 251555
New Market, Maryland, 21774-6154
Velocity Clinical Research - Phoenix /ID# 263871
Phoenix, Arizona, 85006
Coastal Pediatric Research - Summerville /ID# 253534
Summerville, South Carolina, 29486
Velocity Clinical Research Washington DC /ID# 263872
Washington D.C., District of Columbia, 20016-4300
ClinPoint Trials /ID# 251534
Waxahachie, Texas, 75165-1430
Bulgaria5 sites
UMHAT Sveti Georgi /ID# 250808
Plovdiv, 4002
UMHAT Kanev /ID# 248931
Rousse, 7002
Acibadem City Clinic Tokuda University Hospital EAD /ID# 251232
Sofia, 1407
Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 251229
Sofia, 1606
Nova Clinic /ID# 249023
Varna, 9000
Croatia4 sites
Klinicki bolnicki centar Osijek /ID# 252795
Osijek, County of Osijek-Baranja, 31000
Klinicki bolnicki centar Sestre milosrdnice /ID# 252798
Zagreb, City of Zagreb, 10000
Klinicki bolnicki centar Zagreb /ID# 252796
Zagreb, City of Zagreb, 10000
Klinika za dječje bolesti Zagreb /ID# 252792
Zagreb, City of Zagreb, 10000
United Kingdom4 sites
Russells Hall Hospital /ID# 252660
Dudley, DY1 2HQ
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 252298
London, Greater London, E1 2ES
Great Ormond Street Children's Hospital /ID# 253333
London, Greater London, WC1N 3HZ
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 252299
Norwich, Norfolk, NR4 7UY
Germany3 sites
Kinderarztpraxis Dr. Froehlich /ID# 252050
Forchheim, 91301
Universitaetsklinikum Muenster /ID# 251965
Münster, North Rhine-Westphalia, 48149
HELIOS Klinikum Wuppertal /ID# 249022
Wuppertal, 42283
Serbia3 sites
Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 252485
Belgrade, Beograd, 11000
University Children's Hospital 'Tirsova' /ID# 252483
Belgrade, Beograd, 11000
Institute for Child and Youth Health Care of Vojvodina /ID# 252482
Novi Sad, 21000
Hungary1 site
Debreceni Egyetem-Klinikai Kozpont /ID# 250793
Debrecen, Hajdú-Bihar, 4032
About this study
Official title: A Phase 2 Dose Finding Study Evaluating the Safety and Efficacy of Linaclotide in Pediatric Subjects 6 Months to Less Than 2 Years of Age With Functional Constipation (FC).
Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility. Currently, there are no pharmacological therapies approved for the treatment of FC. This study will assess adverse events and change in disease activity with linaclotide therapy in participants with FC.
Linaclotide is an approved drug being developed for the treatment of FC in pediatric patients who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 3 groups, which occur consecutively. Each group receives a different dosage of linaclotide. In Part 2 of the study, participants will be randomly assigned to receive either linaclotide or placebo. There is a 1 in 2 chance that participants will be assigned to placebo. Up to 30 and at least 18 pediatric participants 6 months to less than 2 years of age with FC will be enrolled in the study at approximately 38 sites worldwide.
Read more
Participants will receive oral solution of linaclotide prepared from capsule by parent/guardian once daily for 4 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
- Conditions
- Functional Constipation
- Being tested
- Linaclotide, Placebo
- Keywords
- Linaclotide, pediatric functional constipation, Linzess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinaclotideDrug
Also called Linzess
Capsule; oral
PlaceboDrug
Capsule; oral
| Study group | Role | What they receive |
|---|---|---|
| Part 1, Linaclotide Dose A | Experimental | Linaclotide Dose A capsules, mixed with water and administered orally, once daily for 4 weeks Receives: Drug: Linaclotide |
| Part 1, Linaclotide Dose B | Experimental | Linaclotide Dose B capsules, mixed with water and administered orally, once daily for 4 weeks Receives: Drug: Linaclotide |
| Part 1, Linaclotide Dose C | Experimental | Linaclotide Dose C capsules, mixed with water and administered orally, once daily for 4 weeks Receives: Drug: Linaclotide |
| Part 2, Linaclotide | Experimental | Participants will receive Linaclotide capsules mixed with water and administered orally in Part 2 for 4 weeks. Receives: Drug: Linaclotide |
| Part 2, Placebo | Experimental | Participants will receive placebo capsules mixed with water and administered orally in Part 2 for 4 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period
An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM. The caregiver/parent/guardian/legally authorized representative (LAR) will complete the electronic diary (eDiary), providing data for the SBM frequency rate up to the last dose date equivalent to the 4-week SBM frequency rate.
Measured: Baseline to Week 4
Change From Baseline in Stool Consistency (Bristol Stool Form Scale) During the Study Intervention Period
The caregiver/parent/guardian/legally authorized representative (LAR) will rate and record in an eDiary the consistency of the stool for each BM using the Bristol Stool Form 7-point scale in which 1=Separate hard lumps, like nuts (hard to pass); 2=Sausage-shaped, but lumpy; 3=Like a sausage but with cracks on its surface; 4=Like a sausage or snake, smooth and soft; 5=Soft blobs with clear cut edges (easy to pass); 6=Fluffy pieces with ragged edges, a mushy stool; and 7=Watery, no solid pieces, entirely liquid.
Measured: Baseline to Week 4
Change From Baseline in Straining During the Study Intervention Period
Straining for each LAR/parent/guardian/caregiver-observed BM the child passes was collected daily in the eDiary device, using a 4-point scale (0 = No, not at all; 1 = Yes, a little; 2 = Yes, a lot; 3 = I don't know) based on two questions (did he/she grunt or make a face like he/she was straining). Lower value represents a better outcome and "I don't know" is considered as a missing response. The subject's average straining score for each caregiver-observed BM was derived based on the average of non-missing responses of the two straining questions. The participant's straining score in the 4-week Study Intervention Period was the average of the non-missing average straining scores from all caregiver-observed SBMs during the 4-week Study Intervention Period. If a subject had no caregiver-observed SBMs at baseline, then the baseline straining score reported by the caregiver was missing and, therefore, that subject was not included in the change from baseline straining analysis.
Measured: Baseline to Week 4
Number of Participants With Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Measured: Up to Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start27 Apr 2023
- Primary completion9 Jun 2025
- Study completion9 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Functional ConstipationStudies of the same condition, open and under way.
- More trials run by AbbVieThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ironwood Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760313
- Sponsor's protocol ID
- M21-862
- Other IDs
- 2022-501947-34-00
- Status last verified
- Jan 2026
- First submitted
- 27 Feb 2023
- Last updated
- 6 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Dose Finding Study Evaluating the Safety and Efficacy of Linaclotide in Pediatric Subjects 6 Months to Less Than 2 Years of Age With Functional Constipation (FC).
- ClinicalTrials.gov ID
- NCT05760313
- Acronym / sponsor ID
- M21-862
- Conditions
- Functional Constipation
- Keywords
- Linaclotide, pediatric functional constipation, Linzess
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Collaborators
- Ironwood Pharmaceuticals, Inc.
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 9 Jun 2025 (actual)
- Study completion
- 9 Jun 2025 (actual)
- First posted
- 8 Mar 2023 (actual)
- Results
- Posted 6 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility. Currently, there are no pharmacological therapies approved for the treatment of FC. This study will assess adverse events and change in disease activity with linaclotide therapy in participants with FC.
Linaclotide is an approved drug being developed for the treatment of FC in pediatric patients who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 3 groups, which occur consecutively. Each group receives a different dosage of linaclotide. In Part 2 of the study, participants will be randomly assigned to receive either linaclotide or placebo. There is a 1 in 2 chance that participants will be assigned to placebo. Up to 30 and at least 18 pediatric participants 6 months to less than 2 years of age with FC will be enrolled in the study at approximately 38 sites worldwide.
Participants will receive oral solution of linaclotide prepared from capsule by parent/guardian once daily for 4 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1, Linaclotide Dose A | Experimental | Drug: LinaclotideLinaclotide Dose A capsules, mixed with water and administered orally, once daily for 4 weeks |
| Part 1, Linaclotide Dose B | Experimental | Drug: LinaclotideLinaclotide Dose B capsules, mixed with water and administered orally, once daily for 4 weeks |
| Part 1, Linaclotide Dose C | Experimental | Drug: LinaclotideLinaclotide Dose C capsules, mixed with water and administered orally, once daily for 4 weeks |
| Part 2, Linaclotide | Experimental | Drug: LinaclotideParticipants will receive Linaclotide capsules mixed with water and administered orally in Part 2 for 4 weeks. |
| Part 2, Placebo | Experimental | Drug: PlaceboParticipants will receive placebo capsules mixed with water and administered orally in Part 2 for 4 weeks. |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Individuals must be 6 months to less than 1 year and 11 months old, at the time the legally authorized representative (LAR)/parent/guardian signs the informed consent in alignment with local requirements.
- The LAR/parent/guardian who will be completing the electronic diary (eDiary) is able to read and understand the assessments in the eDiary device and must undergo training.
- Participant meets Rome IV criteria for functional constipation (FC): for at least 1 month before Screening (Visit 1), the participant must meet 2 or more of the following:
- LAR/Parent/Guardian is willing to discontinue any laxatives used before the Preintervention Visit in favor of the protocol-permitted rescue medicine.
Key exclusion criteria (15 listed)
- Participant has conditions that could interfere with drug absorption, including, but not limited to, short bowel syndrome.
- History of clinically significant medical conditions or any other reason that the investigator determines would interfere with the individual's participation in this study or would make the participant an unsuitable candidate to receive study drug.
- Participant has history of:
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 |
|---|---|---|
| LinaclotideAlso: LinzessCapsule; oral | Drug | Part 1, Linaclotide Dose A, Part 1, Linaclotide Dose B, Part 1, Linaclotide Dose C, Part 2, Linaclotide |
| PlaceboCapsule; oral | Drug | Part 2, Placebo |
Primary outcome
Change From Baseline in Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period
Time frame: Baseline to Week 4
An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM. The caregiver/parent/guardian/legally authorized representative (LAR) will complete the electronic diary (eDiary), providing data for the SBM frequency rate up to the last dose date equivalent to the 4-week SBM frequency rate.
Change From Baseline in Stool Consistency (Bristol Stool Form Scale) During the Study Intervention Period
Time frame: Baseline to Week 4
The caregiver/parent/guardian/legally authorized representative (LAR) will rate and record in an eDiary the consistency of the stool for each BM using the Bristol Stool Form 7-point scale in which 1=Separate hard lumps, like nuts (hard to pass); 2=Sausage-shaped, but lumpy; 3=Like a sausage but with cracks on its surface; 4=Like a sausage or snake, smooth and soft; 5=Soft blobs with clear cut edges (easy to pass); 6=Fluffy pieces with ragged edges, a mushy stool; and 7=Watery, no solid pieces, entirely liquid.
Change From Baseline in Straining During the Study Intervention Period
Time frame: Baseline to Week 4
Straining for each LAR/parent/guardian/caregiver-observed BM the child passes was collected daily in the eDiary device, using a 4-point scale (0 = No, not at all; 1 = Yes, a little; 2 = Yes, a lot; 3 = I don't know) based on two questions (did he/she grunt or make a face like he/she was straining). Lower value represents a better outcome and "I don't know" is considered as a missing response. The subject's average straining score for each caregiver-observed BM was derived based on the average of non-missing responses of the two straining questions. The participant's straining score in the 4-week Study Intervention Period was the average of the non-missing average straining scores from all caregiver-observed SBMs during the 4-week Study Intervention Period. If a subject had no caregiver-observed SBMs at baseline, then the baseline straining score reported by the caregiver was missing and, therefore, that subject was not included in the change from baseline straining analysis.
Number of Participants With Adverse Events (AEs)
Time frame: Up to Week 5
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Related trials for Functional Constipation
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This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruitingPhase 3
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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.
ABBVIE INC. study director
AbbVie
38 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Linaclotide in people with Functional Constipation, run by AbbVie at 38 sites in 7 countries.
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 9 inclusion and 15 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 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Bulgaria, Croatia, United Kingdom, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period (time frame: Baseline to Week 4). The study lists 4 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 6 Jan 2026.