Mitochondrial DiseasesNCT03432871
Nicotinamide Riboside and Mitochondrial Biogenesis
A study testing Nicotinamide Riboside in people with Mitochondrial Diseases and Mitochondrial Myopathies, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Mitochondria are important parts of the cell that are responsible for producing energy. The amount of energy they produce depends on how much energy the body needs to function and this energy production can be severely impaired in people with mitochondrial disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mitochondrial Diseases, Mitochondrial Myopathies, Progressive External Ophthalmoplegia
- What is being tested?
- Nicotinamide Riboside
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Dec 2017to 31 Dec 2022
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical and genetic diagnosis of:
- Progressive external ophthalmoplegia (PEO), caused by a single deletion of mitochondrial DNA
- or
- Mitochondrial disease caused by the m.3243A>G or A>T mutation in mitochondrial DNA
- Age 18-70 years
- Women of child-bearing age only if they are not pregnant or breast feeding at the inclusion into the study and agree not to become pregnant during the study. Female participants will undergo a pregnancy test before study commencement.
- Signed informed patient consent
Who cannot join
- Clinically significant liver disease (e.g., cirrhosis or a history of hepatitis)
- Presence of significant other neurological disorders (such as multiple sclerosis, Parkinson's disease) or major co-morbidities (such as definite cognitive impairment, psychiatric disease, heart or lung failure, orthopaedic or rheumatological disorders)
- Females who are at risk of pregnancy (i.e., not using regular contraception), who are pregnant, lactating or planning pregnancy
- Females taking the combined oral contraceptive pill (as oestrogens can induce mitochondrial biogenesis and interfere with study results)
- For MRI - medical contraindication e.g., pacemaker, deep brain stimulator, aneurysm clip or significant claustrophobia
- For biopsy - varicose veins overlying biopsy site, clinically significant lower limb oedema, active lower limb infection, use of anticoagulants or antiplatelet agents that cannot be discontinued, known bleeding diathesis
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB20QQ
About this study
Official title: The Role of Nicotinamide Riboside in Mitochondrial Biogenesis
Mitochondria are important parts of the cell that are responsible for producing energy. The amount of energy they produce depends on how much energy the body needs to function and this energy production can be severely impaired in people with mitochondrial disease. Symptoms of mitochondrial disease vary widely but usually involve the brain, nerves and muscles, as these are tissues that need a lot of energy. Mitochondrial disorders affect 1 in 5000 of the UK population and there is currently no cure.
Some scientists think that increasing the number of mitochondria in the body (mitochondrial biogenesis) might be an effective treatment for the symptoms of mitochondrial disease. Studies carried out in mice have shown that a type of B-vitamin called Nicotinamide Riboside (NR) is able to increase the number of mitochondria, leading to increased energy and a reduction in the symptoms of mitochondrial disease.
Read more
The aim of this study is to investigate if the same B vitamin, Nicotinamide Riboside, can increase energy production and reduce symptoms in humans with mitochondrial disease.
The study will consist of two parts:
Part 1: Participants will be given a single oral dose of Nicotinamide Riboside and the levels of NR in their bloodstream will be measured at regular intervals. This will involve a single overnight stay and simple blood tests.
Part 2: This requires 6 separate visits from each participant. Each participant will undergo a series of standard tests including a muscle biopsy and an MRI scan, then they will take a course of Nicotinamide Riboside (twice daily for 4 weeks). After 4 weeks of treatment, the participants will undergo the same tests again to see if there have been any changes in response to the treatment.
Read the detailed description
Mitochondria are the primary source of energy within the cell, in the form of adenosine triphosphate (ATP). Mitochondrial ATP production is tightly regulated according to the energy requirements of the cell, but little is known about the underlying control mechanisms. This is important for the understanding of the biology of cell energetics and also relevant for patients with rare mitochondrial diseases where it has been proposed that inducing mitochondrial proliferation (biogenesis) might be an effective treatment. However, before embarking on therapeutic studies, it is essential to develop our understanding of the homeostatic mechanisms. Patients with mitochondrial diseases show an enhanced capacity for mitochondrial proliferation, and therefore provide an ideal platform to study mitochondrial homeostasis in vivo in man. The aim of this study, therefore, is to investigate the homeostatic mechanisms in this group of individuals because we are most likely to see an effect in this context.
Nicotinamide riboside (NR), a NAD+ natural precursor, boosts the PGC1α-dependent mitochondrial biogenesis pathway, leading to increased transcription of genes of the oxidative phosphorylation and improved motor performance of myopathic mice. This study is an open-label experimental medicine study using NR with the primary aim of determining whether there is mechanistic link between mitochondrial biogenesis and physiological function in humans with a similar mitochondrial disease.
This project consists of two studies, carried out in series. Both will investigate patients with a clinical and genetic diagnosis of:
- Progressive external ophthalmoplegia (PEO) plus exercise intolerance/fatigue, caused by a single deletion of mitochondrial DNA or ii. Mitochondrial disease caused by the m.3243A>G mutation in mitochondrial DNA
Study 1: a 24 hour study before the experimental intervention, to confirm bioavailability of NR at a dosage within the range of a published study.
Patients (n=5) will be invited to the CRF for an overnight stay. If applicable, a urinary pregnancy test will be carried out before any study procedures commence. A baseline blood sample will be taken before administration of the supplement. Oral NR will be administered at a dosage of 10mg/kg -, and blood samples will be drawn at 30 mins,1, 2, 6, 12 and 24 hours post administration. These samples will be used for measurement of NR/NAD+ levels in blood at the relevant time points and ensure these are at expected levels before proceeding to experimental intervention.
Study 2: a 4-week study to determine whether NR induces mitochondrial biogenesis and affects mitochondrial function in patients with mitochondrial disease.
Patients (n=10) will undergo measurements of mitochondrial biogenesis and physiological activities. Oral NR will be administered at a dosage of 10mg/kg b.i.d, (taken twice daily, after food) and patients will be asked to return weekly for standard observations and to provide a blood sample. After 4 weeks of NR administration, patients will return for a repeat measure of the mitochondrial biogenesis parameters and physiological activities
- Conditions
- Mitochondrial Diseases, Mitochondrial Myopathies, Progressive External Ophthalmoplegia, Progressive Ophthalmoplegia, Progressive; Ophthalmoplegia, External, Mitochondria DNA Deletion
- Being tested
- Nicotinamide Riboside
- Keywords
- Mitochondria, Mitochondrial disease, Nicotinamide Riboside, Niagen, PEO, Single deletion, mtDNA deletion, MELAS, m.3243A>G
- Medical subject headings
- Mitochondrial Diseases, Mitochondrial Myopathies, Ophthalmoplegia, Chronic Progressive External, MELAS Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide RibosideDietary supplement
Also called Niagen, Nicotinamide Riboside Chloride
Nicotinamide Riboside is a member of the Vitamin B family which acts as a precursor to NAD+, an enzyme involved in energy production.
| Study group | Role | What they receive |
|---|---|---|
| Nicotinamide Riboside | Experimental | This is an open-label experimental medicine study.
All subjects will receive the same dosage of the supplement Nicotinamide Riboside. Receives: Dietary Supplement: Nicotinamide Riboside |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability
Change in baseline levels of Nicotinamide Riboside detectable in the bloodstream of participants after a standard oral dose of the supplement (at 0, 0.5, 1, 2, 6, 12 and 24 hours)
Measured: Pharmacokinetic measure - 0, 0.5, 1, 2, 6, 12 and 24 hours post-dose
Safety - Incidence of treatment related adverse events
Observation over 24 hours after Nicotinamide Riboside administration. Recording of any adverse events or reactions
Measured: 24 hours
Safety - change in blood analytes
Change from baseline in safety blood analyte levels - CK, Creatinine, Alanine Transaminase, Aspartate Transaminase (Units U/L)
Measured: 24 hours
Safety - temperature
Change from baseline in patient temperature (degrees celsius, measurement at 0, 0.5, 1, 2, 6, 12 and 24 hours)
Measured: Change measures - 0, 1, 2, 3, 4, 6, 8, 24 hours post-dose
Safety - blood pressure
Change from baseline in patient blood pressure (mmHg, measurement at 0, 0.5, 1, 2, 6, 12 and 24 hours)
Measured: Change measures - 0, 1, 2, 3, 4, 6, 8, 24 hours post-dose
Safety - pulse
Change from baseline in patient pulse (bpm, measurement at 0, 0.5, 1, 2, 6, 12 and 24 hours)
Measured: Change measures - 0, 1, 2, 3, 4, 6, 8, 24 hours post-dose
Mitochondrial biogenesis - Magnetic Resonance Imaging
Change in in vivo measurement of mitochondrial function at the start and end of the 4 weeks of NR treatment (31P-MRS measurement of mitochondrial function - Phosphocreatine replenishment after exercise)
Measured: 4 weeks
Mitochondrial biogenesis - Respiratory Chain Enzyme Analysis
Change from baseline in mitochondrial function at the start and end of the 4 weeks of NR treatment (Respiratory chain enzyme analysis)
Measured: 4 weeks
Mitochondrial biogenesis - mitochondrial DNA quantification
Change from baseline in the amount of mitochondrial DNA at the start and end of the 4 weeks of NR treatment (mtDNA quantification)
Measured: 4 weeks
Secondary outcomes (4)
Impact on mitochondrial disease symptoms - Dynamometric measure of muscle strength
Participants will be asked to complete the dynamometric measure of muscle strength test, using a hand held dynamometer, before and after treatment. Force measured in kg.
Measured: 4 weeks
Impact on mitochondrial disease symptoms - 6-minute walk
Participants will be asked to complete the 6 minute walk test before and after treatment. The distance they can walk in 6 minutes will be measured in metres.
Measured: 4 weeks
Impact on mitochondrial disease symptoms - Quality of life (SF36 - qualitative)
Participants will be asked to complete the SF36 (Short Form 36) Quality of life questionnaire before and after treatment. This is a standard health survey used routinely in clinical practice.
Measured: 4 weeks
Impact on mitochondrial disease symptoms - Timed get-up-and-go.
Participants will be asked to complete the Timed up and go test before and after treatment. The time taken to get up from sitting to standing will be measured in seconds.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start8 Dec 2017
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitochondrial DiseasesStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Experimental medicine study (open label)
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge, Medical Research Council Mitochondrial Biology Unit
- Responsible party
- Principal investigator, Patrick Chinnery, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Patrick Chinnery, Prof., Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432871
- Sponsor's protocol ID
- A094351
- Status last verified
- Jul 2023
- First submitted
- 23 Jan 2018
- Last updated
- 20 Jul 2023
- 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 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Nicotinamide Riboside in Mitochondrial Biogenesis
- ClinicalTrials.gov ID
- NCT03432871
- Acronym / sponsor ID
- A094351
- Conditions
- Mitochondrial Diseases, Mitochondrial Myopathies, Progressive External Ophthalmoplegia, Progressive Ophthalmoplegia, Progressive; Ophthalmoplegia, External, Mitochondria DNA Deletion
- Keywords
- Mitochondria, Mitochondrial disease, Nicotinamide Riboside, Niagen, PEO, Single deletion, mtDNA deletion, MELAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Cambridge, Medical Research Council Mitochondrial Biology Unit
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 14 Feb 2018 (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.
Mitochondria are important parts of the cell that are responsible for producing energy. The amount of energy they produce depends on how much energy the body needs to function and this energy production can be severely impaired in people with mitochondrial disease. Symptoms of mitochondrial disease vary widely but usually involve the brain, nerves and muscles, as these are tissues that need a lot of energy. Mitochondrial disorders affect 1 in 5000 of the UK population and there is currently no cure.
Some scientists think that increasing the number of mitochondria in the body (mitochondrial biogenesis) might be an effective treatment for the symptoms of mitochondrial disease. Studies carried out in mice have shown that a type of B-vitamin called Nicotinamide Riboside (NR) is able to increase the number of mitochondria, leading to increased energy and a reduction in the symptoms of mitochondrial disease.
The aim of this study is to investigate if the same B vitamin, Nicotinamide Riboside, can increase energy production and reduce symptoms in humans with mitochondrial disease.
The study will consist of two parts:
Part 1: Participants will be given a single oral dose of Nicotinamide Riboside and the levels of NR in their bloodstream will be measured at regular intervals. This will involve a single overnight stay and simple blood tests.
Part 2: This requires 6 separate visits from each participant. Each participant will undergo a series of standard tests including a muscle biopsy and an MRI scan, then they will take a course of Nicotinamide Riboside (twice daily for 4 weeks). After 4 weeks of treatment, the participants will undergo the same tests again to see if there have been any changes in response to the treatment.
Detailed description
Mitochondria are the primary source of energy within the cell, in the form of adenosine triphosphate (ATP). Mitochondrial ATP production is tightly regulated according to the energy requirements of the cell, but little is known about the underlying control mechanisms. This is important for the understanding of the biology of cell energetics and also relevant for patients with rare mitochondrial diseases where it has been proposed that inducing mitochondrial proliferation (biogenesis) might be an effective treatment. However, before embarking on therapeutic studies, it is essential to develop our understanding of the homeostatic mechanisms. Patients with mitochondrial diseases show an enhanced capacity for mitochondrial proliferation, and therefore provide an ideal platform to study mitochondrial homeostasis in vivo in man. The aim of this study, therefore, is to investigate the homeostatic mechanisms in this group of individuals because we are most likely to see an effect in this context.
Nicotinamide riboside (NR), a NAD+ natural precursor, boosts the PGC1α-dependent mitochondrial biogenesis pathway, leading to increased transcription of genes of the oxidative phosphorylation and improved motor performance of myopathic mice. This study is an open-label experimental medicine study using NR with the primary aim of determining whether there is mechanistic link between mitochondrial biogenesis and physiological function in humans with a similar mitochondrial disease.
This project consists of two studies, carried out in series. Both will investigate patients with a clinical and genetic diagnosis of:
- Progressive external ophthalmoplegia (PEO) plus exercise intolerance/fatigue, caused by a single deletion of mitochondrial DNA or ii. Mitochondrial disease caused by the m.3243A>G mutation in mitochondrial DNA
Study 1: a 24 hour study before the experimental intervention, to confirm bioavailability of NR at a dosage within the range of a published study.
Patients (n=5) will be invited to the CRF for an overnight stay. If applicable, a urinary pregnancy test will be carried out before any study procedures commence. A baseline blood sample will be taken before administration of the supplement. Oral NR will be administered at a dosage of 10mg/kg -, and blood samples will be drawn at 30 mins,1, 2, 6, 12 and 24 hours post administration. These samples will be used for measurement of NR/NAD+ levels in blood at the relevant time points and ensure these are at expected levels before proceeding to experimental intervention.
Study 2: a 4-week study to determine whether NR induces mitochondrial biogenesis and affects mitochondrial function in patients with mitochondrial disease.
Patients (n=10) will undergo measurements of mitochondrial biogenesis and physiological activities. Oral NR will be administered at a dosage of 10mg/kg b.i.d, (taken twice daily, after food) and patients will be asked to return weekly for standard observations and to provide a blood sample. After 4 weeks of NR administration, patients will return for a repeat measure of the mitochondrial biogenesis parameters and physiological activities
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Experimental medicine study (open label)
| Arm | Type | Receives |
|---|---|---|
| Nicotinamide Riboside | Experimental | Dietary Supplement: Nicotinamide RibosideThis is an open-label experimental medicine study. All subjects will receive the same dosage of the supplement Nicotinamide Riboside. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Progressive external ophthalmoplegia (PEO), caused by a single deletion of mitochondrial DNA
- or
- Mitochondrial disease caused by the m.3243A>G or A>T mutation in mitochondrial DNA
- Age 18-70 years
- Women of child-bearing age only if they are not pregnant or breast feeding at the inclusion into the study and agree not to become pregnant during the study. Female participants will undergo a pregnancy test before study commencement.
Key exclusion criteria (6 listed)
- Clinically significant liver disease (e.g., cirrhosis or a history of hepatitis)
- Presence of significant other neurological disorders (such as multiple sclerosis, Parkinson's disease) or major co-morbidities (such as definite cognitive impairment, psychiatric disease, heart or lung failure, orthopaedic or rheumatological disorders)
- Females who are at risk of pregnancy (i.e., not using regular contraception), who are pregnant, lactating or planning pregnancy
- Females taking the combined oral contraceptive pill (as oestrogens can induce mitochondrial biogenesis and interfere with study results)
- For MRI - medical contraindication e.g., pacemaker, deep brain stimulator, aneurysm clip or significant claustrophobia
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 |
|---|---|---|
| Nicotinamide RibosideAlso: Niagen, Nicotinamide Riboside ChlorideNicotinamide Riboside is a member of the Vitamin B family which acts as a precursor to NAD+, an enzyme involved in energy production. | Dietary supplement | Nicotinamide Riboside |
Primary outcome
Bioavailability
Time frame: Pharmacokinetic measure - 0, 0.5, 1, 2, 6, 12 and 24 hours post-dose
Change in baseline levels of Nicotinamide Riboside detectable in the bloodstream of participants after a standard oral dose of the supplement (at 0, 0.5, 1, 2, 6, 12 and 24 hours)
Safety - Incidence of treatment related adverse events
Time frame: 24 hours
Observation over 24 hours after Nicotinamide Riboside administration. Recording of any adverse events or reactions
Safety - change in blood analytes
Time frame: 24 hours
Change from baseline in safety blood analyte levels - CK, Creatinine, Alanine Transaminase, Aspartate Transaminase (Units U/L)
Safety - temperature
Time frame: Change measures - 0, 1, 2, 3, 4, 6, 8, 24 hours post-dose
Change from baseline in patient temperature (degrees celsius, measurement at 0, 0.5, 1, 2, 6, 12 and 24 hours)
Safety - blood pressure
Time frame: Change measures - 0, 1, 2, 3, 4, 6, 8, 24 hours post-dose
Change from baseline in patient blood pressure (mmHg, measurement at 0, 0.5, 1, 2, 6, 12 and 24 hours)
Safety - pulse
Time frame: Change measures - 0, 1, 2, 3, 4, 6, 8, 24 hours post-dose
Change from baseline in patient pulse (bpm, measurement at 0, 0.5, 1, 2, 6, 12 and 24 hours)
Mitochondrial biogenesis - Magnetic Resonance Imaging
Time frame: 4 weeks
Change in in vivo measurement of mitochondrial function at the start and end of the 4 weeks of NR treatment (31P-MRS measurement of mitochondrial function - Phosphocreatine replenishment after exercise)
Mitochondrial biogenesis - Respiratory Chain Enzyme Analysis
Time frame: 4 weeks
Change from baseline in mitochondrial function at the start and end of the 4 weeks of NR treatment (Respiratory chain enzyme analysis)
Mitochondrial biogenesis - mitochondrial DNA quantification
Time frame: 4 weeks
Change from baseline in the amount of mitochondrial DNA at the start and end of the 4 weeks of NR treatment (mtDNA quantification)
4 secondary outcomes
Impact on mitochondrial disease symptoms - Dynamometric measure of muscle strength
Time frame: 4 weeks
Impact on mitochondrial disease symptoms - 6-minute walk
Time frame: 4 weeks
Impact on mitochondrial disease symptoms - Quality of life (SF36 - qualitative)
Time frame: 4 weeks
Impact on mitochondrial disease symptoms - Timed get-up-and-go.
Time frame: 4 weeks
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 20 Jul 2023.
- 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.
Patrick Chinnery, Prof. principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotinamide Riboside in people with Mitochondrial Diseases and Mitochondrial Myopathies, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 7 inclusion and 6 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 20 Jul 2023. 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 United Kingdom. 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?
Bioavailability (time frame: Pharmacokinetic measure - 0, 0.5, 1, 2, 6, 12 and 24 hours post-dose). The study lists 9 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 20 Jul 2023; AzTrials last refreshed its copy on 2 Nov 2026.