Narcolepsy Type 1Phase 3NCT06505031
A Study of TAK-861 in People With Narcolepsy Type 1
A Phase 3 study testing TAK-861 in people with Narcolepsy Type 1, run by Takeda at 28 sites in 11 countries.
Trial summary
The main aim of this study is to learn how effective TAK-861 is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Narcolepsy Type 1
- What is being tested?
- TAK-861
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 28 sitesin 11 countries
- Study dates
- 8 Oct 2024to 4 Jun 2025
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant has a body mass index (BMI) within the range 18 to 40 kilograms per meter square (kg/m^2).
- The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or International Classification of Sleep Disorders, Third Edition, Text Revision (ICSD-3-TR) diagnosis of NT1.
- The participant has greater than or equal to (≥)4 partial or complete episodes of cataplexy/week (WCR).
- The participant is positive for the human leukocyte antigen (HLA) genotype HLA-DQB1*06:02 or results from radioimmunoassay indicate the participant's cerebrospinal fluid (CSF) orexin (OX)/hypocretin-1 concentration is less than or equal to (≤)110 picograms per milliliter (pg/mL) [or less than one-third of the mean values obtained in normal participants within the same standardized assay].
Who cannot join
- The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS.
- The participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant hepatic disease, thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure; or (c) has any medical condition (such as unstable cardiovascular, pulmonary, renal or gastrointestinal disease).
- The participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
- The participant has a history of cancer in the past 5 years.
- The participant has a clinically significant history of head injury or head trauma.
- The participant has a history of epilepsy, seizure, or convulsion.
- The participant has any current unstable psychiatric disorder or current active major depressive episode (MDE) or an active MDE in the past 6 months.
Trial locations and contacts
28 sites in 11 countries.
28 sites in 11 countries
Belgium5 sites
Takeda Site 2
Alken
Takeda Site 3
Erpent, 5101
Takeda Site 25
Ghent, 9000
Takeda Site 24
Leuven, 3000
Takeda Site 23
Liège, 4000
France5 sites
Takeda Site 6
Bron
Takeda Site 16
Léon, Bordeaux, 33076
Takeda Site 14
Marseille, 13385
Takeda Site 5
Montpellier
Takeda Site 15
Nantes, 44093
China4 sites
Takeda Site 4
Beijing, Beijing Municipality
Takeda Site 26
Guangdong
Takeda Site 28
Shanghai, Shanghai Municipality
Takeda Site 27
Zhengzhou, Henan
Italy3 sites
Takeda Site 7
Bologna, 40139
Takeda Site 17
Pozzilli, 86077
Takeda Site 8
Roma
South Korea3 sites
Takeda Site 11
Seoul, Daegu, 41931
Takeda Site 12
Seoul, 3080
Takeda Site 10
Suwon, Gyeonggi-do, 16247
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)
The main aim of this study is to learn how effective TAK-861 is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment. Other aims are to learn how effective TAK-861 is in lowering the number of sudden, unexpected attacks of muscle weakness while staying conscious (cataplexy) in a week; to learn the effect TAK-861 has on participants' ability to maintain attention, participant's overall quality of life, the spectrum of narcolepsy symptoms and daily life functions; and to learn about the safety of TAK-861.
Read the detailed description
The drug being tested in this study is called TAK-861. TAK-861 is being tested to evaluate its efficacy and safety in participants with narcolepsy with cataplexy (narcolepsy type 1 [NT1]).
The study will enroll approximately 93 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:
- TAK-861
- Placebo
The study drug will be administered for 12 weeks. This multi-center trial will be conducted globally.
- Conditions
- Narcolepsy Type 1
- Being tested
- TAK-861, Placebo
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-861Drug
Oral tablet.
PlaceboDrug
TAK-861-matching placebo tablet.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received oveporexton matching placebo tablets, orally, twice daily (BID) for 12 weeks. Receives: Drug: Placebo |
| TAK-861 | Experimental | Participants received oveporexton tablets, 2 milligrams (mg), orally, BID for 12 weeks. Receives: Drug: TAK-861 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 12 in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT) Wake Trials
The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the inability or delayed tendency to fall asleep. This tendency to fall asleep is measured via electroencephalography-derived sleep latency in the MWT. The MWT consists of four 40-minute sessions (trials) done 2 hours apart. Sleep latency in each session was recorded. Participants were required to stay awake in between the four sessions. A positive change from baseline indicates an improvement. The linear MMRM was used for analysis.
Measured: Baseline, Week 12
Change From Baseline to Week 12 in ESS Total Score
The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; the scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness. A negative change from baseline indicates an improvement. The linear mixed effects model for repeated measures (MMRM) was used for analysis.
Measured: Baseline, Week 12
Secondary outcomes (7)
Weekly Cataplexy Rate (WCR) at Week 12
Participants completed a daily participant-reported cataplexy diary to record self-reported episodes of cataplexy attacks. WCR = (total number of cataplexy attacks over a number of non-missing diary days for a given period/number of non-missing diary days in that period) * 7. The generalized estimating equations (GEE) model was used for analysis. Reported here is the estimated mean of incidence rate with a 95 percent (%) confidence interval (CI).
Measured: Week 12
Change From Baseline to Week 12 in Mean Number of Lapses on the Psychomotor Vigilance Test (PVT)
The PVT is a simple reaction performance task that aims to measure sustained attention. The mean number of lapses (delayed responses to a visual cue from intraday sessions) from the two 10-minute intraday sessions was used as a measure of objective sustained attention. A negative change from baseline indicates an improvement. A constrained Longitudinal Data Analysis (cLDA) model was used to analyze the mean number of lapses and to estimate change from baseline at each visit.
Measured: Baseline, Week 12
Proportion of Participants With Improved Patient Global Impression of Change (PGI-C) Score at Week 12
The PGI-C is a participant self-rated scale to assess change in daytime sleepiness and overall narcolepsy symptoms. The PGI-C includes 7 items being scored from 1 (best outcome) to 7 (worst outcome) with 4 being no change. Responders were the participants reporting "1=very much improved" or "2=much improved" on PGI-C. Responder rate (proportion of participants who were responders) was estimated using a GEE model.
Measured: Week 12
Change From Baseline to Week 12 in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) Total Score
The NSS-CT is a 15-item self-administered questionnaire that assesses the severity and consequences of the 5 major narcolepsy symptoms such as daytime sleepiness, cataplexy, hallucinations, sleep paralysis, and disturbed nighttime sleep (DNS) with a total score range of 0 to 57 (sum of 6 items that assess symptoms severity are rated using a six-point Likert scale [0-5] and 9 items that describe the symptom effect on daily life are rated using a four-point Likert scale [0-3]). Higher total scores mean a worse outcome. A negative change from baseline indicates an improvement. The linear MMRM was used for analysis.
Measured: Baseline, Week 12
Change From Baseline to Week 12 in Functional Impacts of Narcolepsy Instrument (FINI) Domain Scores
The FINI measures the functional impacts of narcolepsy across 6 domains Tiredness (items 1-7), Cognitive Functioning (items 8-12), Cataplexy (items 13-17), Social Activities (items 18-21), Everyday Activities (items 22-25), and Everyday Responsibilities (items 26-28). Each item asks about the impact that narcolepsy has had on their daily functioning during the past 7 days, and is scored from 0 to 4, where 0 indicates the best health and 4 the worst. An average score is calculated for each domain and then standardized to a 0-100 scale, where 0 indicates the best health and 100 the worst health. Standardized score = average score/4 × 100. A negative change from baseline indicates and improvement. The linear MMRM was used for analysis.
Measured: Baseline, Week 12
Change From Baseline to Week 12 in Short Form-36 Survey (SF-36) Mental and Physical Component Scores
The SF-36 is a 36-item, participant-reported survey of participant health that assesses the quality of life and includes both physical and mental components. It consists of 8 scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which contribute variably to the physical and mental component summary scores. The component summary is scored based on a normal value of 50 based on US population average, with a normative range considered from 45-55. The lower the score the more disability. A positive change from baseline indicates an improvement, and a change greater than 3 points is considered minimally clinically meaningful. The linear MMRM was used for analysis.
Measured: Baseline, Week 12
Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAE)
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start8 Oct 2024
- Primary completion4 Jun 2025
- Study completion4 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Narcolepsy Type 1Studies of the same condition, open and under way.
- More trials run by TakedaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505031
- Sponsor's protocol ID
- TAK-861-3002
- Other IDs
- 2024-511998-30-00
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2024
- Last updated
- 16 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Publications
Romero H, Savva Y, Crawford S, Howerter A, Dave S, Doll H. Psychometric properties of the novel patient-reported Functional Impacts of Narcolepsy Instrument (FINI) using data from phase 3 clinical trials in narcolepsy type 1. Front Neurol. 2026 Oct 15;17:1884901. doi: 10.3389/fneur.2026.1884901. eCollection 2026.
PubMed 42959371Dauvilliers Y, Mignot E, Antczak J, Arnulf I, Barateau L, Buntinx E, Corser B, Iranzo A, Khatami R, Lammers GJ, Lederer K, Nilsen KB, Pizza F, Schmidt MH, Sivam S, Sum-Ping O, Taniguchi M, Zhan S, Abraham A, Cai A, Du Y, Etherton MR, Faessel H, Hsiao S, Kadali H, Koundourakis E, Naylor M, Neuwirth R, Olsson T, Rogers R, Sheikh S, Tanaka S, von Rosenstiel P, von Hehn C, Hang Y, Yao B, Del Rio Villegas R, Plazzi G. Oveporexton for Narcolepsy Type 1 - Results from Two Phase 3 Trials. N Engl J Med. 2026 Sep 9. doi: 10.1056/NEJMoa2601598. Online ahead of print.
PubMed 42714024
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)
- ClinicalTrials.gov ID
- NCT06505031
- Acronym / sponsor ID
- TAK-861-3002
- Conditions
- Narcolepsy Type 1
- Keywords
- Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 17 Jul 2024 (actual)
- Results
- Posted 16 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is to learn how effective TAK-861 is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment. Other aims are to learn how effective TAK-861 is in lowering the number of sudden, unexpected attacks of muscle weakness while staying conscious (cataplexy) in a week; to learn the effect TAK-861 has on participants' ability to maintain attention, participant's overall quality of life, the spectrum of narcolepsy symptoms and daily life functions; and to learn about the safety of TAK-861.
Detailed description
The drug being tested in this study is called TAK-861. TAK-861 is being tested to evaluate its efficacy and safety in participants with narcolepsy with cataplexy (narcolepsy type 1 [NT1]).
The study will enroll approximately 93 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:
- TAK-861
- Placebo
The study drug will be administered for 12 weeks. This multi-center trial will be conducted globally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants received oveporexton matching placebo tablets, orally, twice daily (BID) for 12 weeks. |
| TAK-861 | Experimental | Drug: TAK-861Participants received oveporexton tablets, 2 milligrams (mg), orally, BID for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The participant has a body mass index (BMI) within the range 18 to 40 kilograms per meter square (kg/m^2).
- The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or International Classification of Sleep Disorders, Third Edition, Text Revision (ICSD-3-TR) diagnosis of NT1.
- The participant has greater than or equal to (≥)4 partial or complete episodes of cataplexy/week (WCR).
- The participant is positive for the human leukocyte antigen (HLA) genotype HLA-DQB1*06:02 or results from radioimmunoassay indicate the participant's cerebrospinal fluid (CSF) orexin (OX)/hypocretin-1 concentration is less than or equal to (≤)110 picograms per milliliter (pg/mL) [or less than one-third of the mean values obtained in normal participants within the same standardized assay].
Key exclusion criteria (7 listed)
- The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS.
- The participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant hepatic disease, thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure; or (c) has any medical condition (such as unstable cardiovascular, pulmonary, renal or gastrointestinal disease).
- The participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
- The participant has a history of cancer in the past 5 years.
- The participant has a clinically significant history of head injury or head trauma.
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 |
|---|---|---|
| TAK-861Oral tablet. | Drug | TAK-861 |
| PlaceboTAK-861-matching placebo tablet. | Drug | Placebo |
Primary outcome
Change From Baseline to Week 12 in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT) Wake Trials
Time frame: Baseline, Week 12
The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the inability or delayed tendency to fall asleep. This tendency to fall asleep is measured via electroencephalography-derived sleep latency in the MWT. The MWT consists of four 40-minute sessions (trials) done 2 hours apart. Sleep latency in each session was recorded. Participants were required to stay awake in between the four sessions. A positive change from baseline indicates an improvement. The linear MMRM was used for analysis.
Change From Baseline to Week 12 in ESS Total Score
Time frame: Baseline, Week 12
The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; the scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness. A negative change from baseline indicates an improvement. The linear mixed effects model for repeated measures (MMRM) was used for analysis.
7 secondary outcomes
Weekly Cataplexy Rate (WCR) at Week 12
Time frame: Week 12
Change From Baseline to Week 12 in Mean Number of Lapses on the Psychomotor Vigilance Test (PVT)
Time frame: Baseline, Week 12
Proportion of Participants With Improved Patient Global Impression of Change (PGI-C) Score at Week 12
Time frame: Week 12
Change From Baseline to Week 12 in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) Total Score
Time frame: Baseline, Week 12
Change From Baseline to Week 12 in Functional Impacts of Narcolepsy Instrument (FINI) Domain Scores
Time frame: Baseline, Week 12
Change From Baseline to Week 12 in Short Form-36 Survey (SF-36) Mental and Physical Component Scores
Time frame: Baseline, Week 12
Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAE)
Time frame: Up to 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42959371Romero H, Savva Y, Crawford S, Howerter A, Dave S, Doll H. Psychometric properties of the novel patient-reported Functional Impacts of Narcolepsy Instrument (FINI) using data from phase 3 clinical trials in narcolepsy type 1. Front Neurol. 2026 Oct 15;17:1884901. doi: 10.3389/fneur.2026.1884901. eCollection 2026.
- Derived from this study: PubMed 42714024Dauvilliers Y, Mignot E, Antczak J, Arnulf I, Barateau L, Buntinx E, Corser B, Iranzo A, Khatami R, Lammers GJ, Lederer K, Nilsen KB, Pizza F, Schmidt MH, Sivam S, Sum-Ping O, Taniguchi M, Zhan S, Abraham A, Cai A, Du Y, Etherton MR, Faessel H, Hsiao S, Kadali H, Koundourakis E, Naylor M, Neuwirth R, Olsson T, Rogers R, Sheikh S, Tanaka S, von Rosenstiel P, von Hehn C, Hang Y, Yao B, Del Rio Villegas R, Plazzi G. Oveporexton for Narcolepsy Type 1 - Results from Two Phase 3 Trials. N Engl J Med. 2026 Sep 9. doi: 10.1056/NEJMoa2601598. Online ahead of print.
- To obtain more information on the study, click here/on this link.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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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.
Medical Director study director
Takeda
28 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TAK-861 in people with Narcolepsy Type 1, run by Takeda at 28 sites in 11 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 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Belgium, France, China, Italy, South Korea and 6 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. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 16 Jul 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 to Week 12 in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT) Wake Trials (time frame: Baseline, Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06505031, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.