Opioid Use DisorderPhase 3NCT02672111
Long-Term Safety Study of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder
A Phase 3 study testing CAM2038 q1w or q4w exposure to SL BPN/NX and CAM2038 q1w or q4w new to BPN treatment in people with Opioid Use Disorder, run by Braeburn Pharmaceuticals at 32 sites in 8 countries.
Trial summary
Open-label multi-center, 48 week safety study, consistent with standard practice for long-term safety studies. This one year safety study will utilize CAM2038 q1w (once weekly) and q4w (once monthly) and will have 3 phases: Screening, Treatment, and Follow-up. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- CAM2038 q1w or q4w exposure to SL BPN/NX and CAM2038 q1w or q4w new to BPN treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 32 sitesin 8 countries
- Study dates
- Nov 2015to May 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must provide written informed consent prior to the conduct of any study-related procedures.
- Male or female, 18-65 years of age, inclusive.
- Female subjects of childbearing potential must be willing to use a highly effective method of contraception during the entire study (Screening Visit to Follow-Up Visit).
- Current diagnosis of moderate or severe opioid use disorder (DSM-V) or past medical history of opioid use disorder currently being treated with SL BPN.
- Considered by the Investigator to be a good candidate for BPN treatment, based on medical and psychosocial history.
- Subjects must meet one of the following criteria for BPN treatment history:
- Voluntarily seeking treatment for opioid use disorder (not currently on BPN treatment for at least last 60 days but seeking BPN treatment), or;
- Currently on SL BPN treatment.
Who cannot join
- Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS).
- Current diagnosis of chronic pain requiring opioids for treatment.
- Current DSM-V diagnosis for moderate to severe substance use disorder (including alcohol) other than opioids, caffeine or nicotine and currently being treated as the primary substance use disorder.
- Recent history of or current evidence of suicidal ideation or active suicidal behavior as based on the Columbia Suicide Severity Rating Scale (C-SSRS) ("Yes" responses to questions 4 or 5).
- Pregnant or lactating or planning to become pregnant during the study.
- Hypersensitivity or allergy to naloxone (only for subjects receiving the SL BPX test dose), BPN or excipients of CAM2038.
Show all 14Show fewer
- Requires chronic use of agents that are strong inhibitors or inducers of cytochrome P450 3A4 (CYP 3A4) such as some azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., clarithromycin), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir).
- Hepatitis, unless under stable treatment, at the discretion of the Investigator.
- Any pending legal action that could prohibit participation or compliance in the study.
- Exposure to any investigational drug within the 4 weeks prior to Screening.
- Aspartate aminotransferase (AST) levels ≥3 X the upper limit of normal, alanine aminotransferase (ALT), levels ≥ 3 X the upper limit of normal, total bilirubin ≥ 1.5 X the upper limit of normal, or creatinine ≥ 1.5 X upper limit of normal on the Screening laboratory assessments, or other clinically significant laboratory abnormalities, which in the opinion of the Investigator may prevent the subject from safely participating in study.
- Participants with a history of risk factors of Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) or an ECG demonstrating a Fridericia's corrected QT interval (QTcF) >450 msec in males and QTcF > 470 in females at screening.
- Significant symptoms, medical conditions, or other circumstances which, in the opinion of the Investigator, would preclude compliance with the protocol, adequate cooperation in the study or obtaining informed consent, or may prevent the subject from safely participating in study. This includes, but is not limited to, subjects with attention deficit hyperactivity disorder receiving central stimulants (e.g. methylphenidate or other central stimulants), as well as subjects with severe respiratory insufficiency, respiratory depression, airway obstruction, gastrointestinal motility disorders, severe hepatic insufficiency, planned surgery and prior treatment with monoamine oxidase inhibitors.
- Is an employee of the Investigator or the trial site, with direct involvement in the proposed trial or other studies under the direction of the Investigator or trial site, or is a family member of an employee or of the Investigator.
Trial locations and contacts
32 sites in 8 countries.
32 sites in 8 countries
United States10 sites
Wellness and Research Center
Belvidere, New Jersey, 07823
Comprehensive Clinical Research
Berlin, New Jersey, 08009
Parkway Medical Center
Birmingham, Alabama, 35215
Frost Medical Group, LLC
Conshohocken, Pennsylvania, 19428
Stanley Street Treatment and Resources Inc
Fall River, Massachusetts, 02720
Haleyville Clinical Research LLC
Haleyville, Alabama, 35565
Boyett Health Services Inc
Hamilton, Alabama, 35570
Dr Vijapura and Associates
Jacksonville, Florida, 32256
TRY Research
Maitland, Florida, 32751
STARS/Columbia University
New York, New York, 10019
Germany5 sites
Gemeinschaftspraxis Schnaitmann/Schaffert Salzstrasse
Heilbronn, 74076
Studikum - Zentrum fur Klinische Studien im Praxiszentrum Friedrichsplatz
Kassel, 34117
Klinik fur Abhangiges Verhalten und Suchtmedizin Zentralinstitut
Mannheim, 68159
Psychosoziale Begleitung - Praxis Boniakowski
Regensburg, 93051
Praxisgemeinschaft
Stuttgart, 70197
Australia4 sites
Newcastle Community Health Services
Newcastle, NSW 2300
Drug & Alcohol Services SA Drug and Alcohol Services
Norwood, 5070
Royal Prince Alfred Hospital
Sydney, 2050
South Eastern Sydney Local Health District (SESLHD)
Sydney, NSW 2010
United Kingdom4 sites
NHS Tayside
Dundee, DD1 9SY
Blackberry Centre Blackberry Hill Hospital
Fishponds, Bristol, BS16 2EW
Hellesdon Hospital The Weavers Centre
Hellesdon, Norwich, NR6 5BE
Lambeth Drug and Alcohol Service Lorraine Hewitt House
London, SW9 8DG
Taiwan3 sites
China Medical University Hospita
Taichung, 40447
Jinan Psychiatric Center, Ministry of Health and Welfa
Tainan, Tainan County, 717
Taipei City Hospital
Taipei, 103
Denmark2 sites
Center for Misbrugsbehandling
Aarhus, 8000
Behandlingscenter Odense
Odense, 5000
Hungary2 sites
Clinexpert Kft
Budapest, 1033
XVI. Kerület Kertvárosi Egészségügyi Szolgálata, Addiktológia
Budapest, 1165
Sweden2 sites
Metadonsektionen
Stockholm, 118 67
Centrallasarettet Vasteras
Västerås, 72189
About this study
Official title: An Open-Label Multicenter Study Assessing the Long-Term Safety of a Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injection Depot of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder
Open-label multi-center, 48 week safety study, consistent with standard practice for long-term safety studies. This one year safety study will utilize CAM2038 q1w (once weekly) and q4w (once monthly) and will have 3 phases: Screening, Treatment, and Follow-up.
Read the detailed description
Open-label multi-center, 48 week safety study, consistent with standard practice for long-term safety studies. This one year safety study will utilize CAM2038 q1w (once weekly) and q4w (once monthly) and will have 3 phases: Screening, Treatment, and Follow-up.
Patients who are currently taking sublingual (SL) BPN (weekly or monthly prescription visits) or individuals who are actively seeking BPN treatment but who have not yet begun a treatment regimen, may be eligible for the study.
Following Screening, qualified subjects meeting inclusion criteria and not meeting exclusion criteria will be initiated on either CAM2038 q1w or q4w, based on their current treatment status (qualified subjects currently on SL BPN or seeking BPN treatment). Qualified subjects will be initiated or transitioned to CAM2038 q1w or q4w as follows:
Initiation of BPN treatment - initiate with CAM2038 q1w
Currently receiving SL BPN treatments - transfer to corresponding CAM2038 q1w or q4w dose
- Conditions
- Opioid Use Disorder
- Being tested
- CAM2038 q1w or q4w exposure to SL BPN/NX, CAM2038 q1w or q4w new to BPN treatment
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAM2038 q1w or q4w exposure to SL BPN/NXDrug
Also called Buprenorphine injection
CAM2038 q1w or q4w new to BPN treatmentDrug
Also called Buprenorphine injection
| Study group | Role | What they receive |
|---|---|---|
| CAM2038 q1w or q4w exposure to SL BPN/NX | Experimental | CAM2038 (buprenorphine FluidCrystal®)
Subjects previously exposed to SL BPN/NX who received CAM2038 q1w or q4w Receives: Drug: CAM2038 q1w or q4w exposure to SL BPN/NX |
| CAM2038 q1w or q4w new to BPN treatment | Experimental | CAM2038 (buprenorphine FluidCrystal®) New to BPN Treatment who received CAM2038r q1w or q4w Receives: Drug: CAM2038 q1w or q4w new to BPN treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period. Safety Assessments: Adverse events (AEs) and serious adverse events (SAEs)-Overall Safety Population
Measured: 12 months- 48 week
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Full Exposure Safety Population
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period. Safety Assessments: Adverse events (AEs) and serious adverse events (SAEs)-Full Exposure Safety Population
Measured: 12 months- 48 week
Secondary outcomes (7)
Mean Percentage of Negative Urine Toxicology Results for Illicit Opioid Use Supported by Self Reported Illicit Opioid Use (Efficacy Population)
The following is a summary of Mean Percentage of Negative Urine Toxicology Results for Illicit Opioid Use Supported by Self Reported Illicit Opioid Use (Efficacy Population)
Measured: 12 months (48 weeks)
Mean Percentage of Self-reported No Illicit Opioid Use (Efficacy Population)
The following is a summary of Mean Percentage of Self-Reported No Illicit Opioid Use during the entire study (Efficacy Population). The proportion of patients who reported no illicit opioid use during the study was analyzed. For example if a subject provided 10 self reports and 2 out of the 10 were "Used", the percentage for the subject would be 20%. The average percentage of all patients is provided.
Measured: 12 months (48 weeks)
Summary of Retention in Treatment (Efficacy Population)
The following is a summary of treatment retention over 48 weeks
Measured: 48 weeks of treatment
Summary of Clinical Opiate Withdrawal Scale (COWS) at Selected Time Points (Efficacy Population)
A summary of COWS (administered by the Clinician) over 48 weeks to show withdrawal symptoms from baseline to end of treatment. This scale consists of 11 common opiate withdrawal signs or symptoms, rated on a numeric scale from 0 to 4 or 5 and based on a timed period of observation of the subject by the rater. Higher scores are associated with greater withdrawal symptoms with a total range for all items of between 0-48
Measured: 12 months- 48 week
Summary of Subjective Opiate Withdrawal Scale (SOWS) at Selected Time Points (Efficacy Population)
Summary of SOWS over time to show withdrawal symtons, from baseline to end of treatment. This form contains 16 questions that rate the intensity of withdrawal from 0 ("Not at all") to 4 ("Extremely"), with higher scores associated with greater withdrawal symptoms and total range for all items of 0-64
Measured: 12 months- 48 week
Summary of Desire to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population)
The following table summarizes the desire to use measurements over a period of 12 months - 48 weeks. Desire to Use assessments were administered using a unipolar 100 mm VAS. Subjects were asked "Since your last scheduled assessment visit, indicate your worst or strongest desire to use opioids, where 0 = No desire to use and 100 mm = Strongest possible desire.
Measured: 12 months- 48 week
Summary of Need to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population)
The following results summarize the need to use VAS over a period of 12 months - 48 weeks. Need to Use assessments were administered using a unipolar 100 mm VAS. Subjects were asked "Since your last scheduled assessment visit, indicate your worst or strongest need to use opioids, where 0 = No need to use and 100 mm = Strongest possible need.
Measured: 12 months- 48 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startNov 2015
- Primary completionMay 2017
- Study completionMay 2017
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 (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Braeburn Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Frost, MD, Principal investigator, Frost Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672111
- Sponsor's protocol ID
- HS-14-499
- Status last verified
- Jul 2019
- First submitted
- 15 Jan 2016
- Last updated
- 15 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Frost M, Bailey GL, Lintzeris N, Strang J, Dunlop A, Nunes EV, Jansen JB, Frey LC, Weber B, Haber P, Oosman S, Kim S, Tiberg F. Long-term safety of a weekly and monthly subcutaneous buprenorphine depot (CAM2038) in the treatment of adult out-patients with opioid use disorder. Addiction. 2019 Aug;114(8):1416-1426. doi: 10.1111/add.14636. Epub 2019 Jun 3.
PubMed 31013390
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Multicenter Study Assessing the Long-Term Safety of a Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injection Depot of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT02672111
- Acronym / sponsor ID
- HS-14-499
- Conditions
- Opioid Use Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Braeburn PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Posted 1 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label multi-center, 48 week safety study, consistent with standard practice for long-term safety studies. This one year safety study will utilize CAM2038 q1w (once weekly) and q4w (once monthly) and will have 3 phases: Screening, Treatment, and Follow-up.
Detailed description
Open-label multi-center, 48 week safety study, consistent with standard practice for long-term safety studies. This one year safety study will utilize CAM2038 q1w (once weekly) and q4w (once monthly) and will have 3 phases: Screening, Treatment, and Follow-up.
Patients who are currently taking sublingual (SL) BPN (weekly or monthly prescription visits) or individuals who are actively seeking BPN treatment but who have not yet begun a treatment regimen, may be eligible for the study.
Following Screening, qualified subjects meeting inclusion criteria and not meeting exclusion criteria will be initiated on either CAM2038 q1w or q4w, based on their current treatment status (qualified subjects currently on SL BPN or seeking BPN treatment). Qualified subjects will be initiated or transitioned to CAM2038 q1w or q4w as follows:
Initiation of BPN treatment - initiate with CAM2038 q1w
Currently receiving SL BPN treatments - transfer to corresponding CAM2038 q1w or q4w dose
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAM2038 q1w or q4w exposure to SL BPN/NX | Experimental | Drug: CAM2038 q1w or q4w exposure to SL BPN/NXCAM2038 (buprenorphine FluidCrystal®) Subjects previously exposed to SL BPN/NX who received CAM2038 q1w or q4w |
| CAM2038 q1w or q4w new to BPN treatment | Experimental | Drug: CAM2038 q1w or q4w new to BPN treatmentCAM2038 (buprenorphine FluidCrystal®) New to BPN Treatment who received CAM2038r q1w or q4w |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject must provide written informed consent prior to the conduct of any study-related procedures.
- Male or female, 18-65 years of age, inclusive.
- Female subjects of childbearing potential must be willing to use a highly effective method of contraception during the entire study (Screening Visit to Follow-Up Visit).
- Current diagnosis of moderate or severe opioid use disorder (DSM-V) or past medical history of opioid use disorder currently being treated with SL BPN.
- Considered by the Investigator to be a good candidate for BPN treatment, based on medical and psychosocial history.
Key exclusion criteria (14 listed)
- Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS).
- Current diagnosis of chronic pain requiring opioids for treatment.
- Current DSM-V diagnosis for moderate to severe substance use disorder (including alcohol) other than opioids, caffeine or nicotine and currently being treated as the primary substance use disorder.
- Recent history of or current evidence of suicidal ideation or active suicidal behavior as based on the Columbia Suicide Severity Rating Scale (C-SSRS) ("Yes" responses to questions 4 or 5).
- Pregnant or lactating or planning to become pregnant during the study.
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 |
|---|---|---|
| CAM2038 q1w or q4w exposure to SL BPN/NXAlso: Buprenorphine injection | Drug | CAM2038 q1w or q4w exposure to SL BPN/NX |
| CAM2038 q1w or q4w new to BPN treatmentAlso: Buprenorphine injection | Drug | CAM2038 q1w or q4w new to BPN treatment |
Primary outcome
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population
Time frame: 12 months- 48 week
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period. Safety Assessments: Adverse events (AEs) and serious adverse events (SAEs)-Overall Safety Population
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Full Exposure Safety Population
Time frame: 12 months- 48 week
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period. Safety Assessments: Adverse events (AEs) and serious adverse events (SAEs)-Full Exposure Safety Population
7 secondary outcomes
Mean Percentage of Negative Urine Toxicology Results for Illicit Opioid Use Supported by Self Reported Illicit Opioid Use (Efficacy Population)
Time frame: 12 months (48 weeks)
Mean Percentage of Self-reported No Illicit Opioid Use (Efficacy Population)
Time frame: 12 months (48 weeks)
Summary of Retention in Treatment (Efficacy Population)
Time frame: 48 weeks of treatment
Summary of Clinical Opiate Withdrawal Scale (COWS) at Selected Time Points (Efficacy Population)
Time frame: 12 months- 48 week
Summary of Subjective Opiate Withdrawal Scale (SOWS) at Selected Time Points (Efficacy Population)
Time frame: 12 months- 48 week
Summary of Desire to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population)
Time frame: 12 months- 48 week
Summary of Need to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population)
Time frame: 12 months- 48 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31013390Frost M, Bailey GL, Lintzeris N, Strang J, Dunlop A, Nunes EV, Jansen JB, Frey LC, Weber B, Haber P, Oosman S, Kim S, Tiberg F. Long-term safety of a weekly and monthly subcutaneous buprenorphine depot (CAM2038) in the treatment of adult out-patients with opioid use disorder. Addiction. 2019 Aug;114(8):1416-1426. doi: 10.1111/add.14636. Epub 2019 Jun 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Frost, MD principal investigator
Frost Medical Group
32 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CAM2038 q1w or q4w exposure to SL BPN/NX and CAM2038 q1w or q4w new to BPN treatment in people with Opioid Use Disorder, run by Braeburn Pharmaceuticals at 32 sites in 8 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 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Germany, Australia, United Kingdom, Taiwan and 3 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 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 1 Aug 2019). 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?
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population (time frame: 12 months- 48 week). 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 NCT02672111, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020; AzTrials last refreshed its copy on 8 Nov 2026.