Epileptic Encephalopathy, Childhood-OnsetPhase 4NCT03779672
Memantine for Epileptic Encephalopathy
A Phase 4 study testing Memantine Hydrochloride 10 mg in people with Epileptic Encephalopathy, Childhood-Onset, run by Kenneth Myers, MD at 1 site in Canada.
Trial summary
This study will evaluate the potential benefit of memantine hydrochloride as treatment for children with epileptic encephalopathy using a double-blind placebo-controlled cross-over design. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Epileptic Encephalopathy, Childhood-Onset
- What is being tested?
- Memantine Hydrochloride 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 7 Feb 2019to 8 Feb 2022
- Phase
- Phase 4
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Written informed consent obtained
- Age 6-18 years (Weight ≥ 20 kg)
- Clinical diagnosis of epileptic encephalopathy
- Subject with epilepsy and developmental impairment;
- Epileptic activity itself contributes to severe cognitive and behavioural impairments
- Patients will typically have already have trialed at least two standard therapies
Show all 9Show fewer
- Females of childbearing age:
- Negative urinary pregnancy test at screening
- Agree to use effective contraception for the duration of the study
Who cannot join
- Inability of a parent or legal guardian to give informed consent for any reason.
- Known hypersensitivity to memantine hydrochloride
- Taking concomitant Amantadine, Ketamine or Dextromethorphan, Cimetidine, Ranitidine, Procainamide, Quinidine, Quinine, Hydrochlorothiazide, Anticholinergics, L-dopa, Anticoagulant,
- Any degree of renal impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double-blind Placebo-controlled Trial of Memantine Hydrochloride for the Treatment of Childhood-onset Epileptic Encephalopathies
This study will evaluate the potential benefit of memantine hydrochloride as treatment for children with epileptic encephalopathy using a double-blind placebo-controlled cross-over design.
Read the detailed description
Memantine, a drug approved for Alzheimer's dementia, exerts its therapeutic effect through its action as a low to moderate affinity non-competitive (open channel) N-methyl-D-aspartate receptor (NMDA-R) antagonist, which binds preferentially to the NMDA receptor-operated cation channels. It blocks the effects of persistently elevated levels of glutamate that may lead to neuronal dysfunction. Memantine may also have anti-inflammatory effects. Memantine has been used off-label in children and adolescents with autism spectrum disorder, to improve the cognitive impairment.
Epileptic encephalopathy, as well as other forms of epilepsy, may occur as a result of multiple etiologies, including genetic and inflammatory pathologies. Ion channels were long considered to be implicated in genetic epilepsy. Indeed one of the many possible causes of epilepsy is NMDA receptor dysfunction.
In the present study, the investigators plan to investigate the potential benefit of memantine as a treatment for epileptic encephalopathy. A double-blind placebo-controlled cross-over design will be used, with participants receiving 6 weeks of memantine and 6 weeks of placebo, with a 2-week washout period in between.
- Being tested
- Memantine Hydrochloride 10 mg
- Keywords
- Memantine, N-methyl-D-aspartate receptor, Serum inflammatory, Seizure
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memantine Hydrochloride 10 mgDrug
Also called PrSANDOZ MEMANTINE FCT10 mg Drug Identification Number (DIN) 02375532
- Week #1: 5 mg id (am), 1 caps
- Week #2: 5 mg bid (am and pm), 2 caps
- Weeks #3-6: 5 mg am \& 2x 5 mg pm, 3 caps
- Weeks #7-8: Washout
Placebo
- Week #9: id (am), 1 caps
- Week #10: bid (am and pm), 2 caps
- Weeks #11-14: 1 caps am \& 2 caps pm, 3 caps
OR Placebo
- Week #1: id (am), 1 caps
- Week #2: bid (am and pm), 2 caps
- Weeks #3-6: 1 caps am \& 2 caps pm, 3 caps
- Weeks #7-8: Washout
Memantine
- Week #9: 5 mg id (am), 1 caps
- Week #10: 5 mg bid (am and pm), 2 caps
- Weeks #11-14: 5 mg am \& 2x 5 mg pm, 3 caps
| Study group | Role | What they receive |
|---|---|---|
| Memantine Hydrochloride 10 mg Placebo | Active comparator | Blue colour capsules, for oral administration, containing 5 mg of active memantine or matching placebo for oral administration.
Dose regimen:
Memantine Hydrochloride
* Week #1: 5 mg id (am), 1 caps
* Week #2: 5 mg bid (am and pm), 2 caps
* Weeks #3-6: 5 mg am \& 2x 5 mg pm, 3 caps
Washout (Weeks #7-8)
Placebo
* Week #9: id (am), 1 caps
* Week #10: bid (am and pm), 2 caps
* Weeks #11-14: 1 caps am \& 2 caps pm, 3 caps Receives: Drug: Memantine Hydrochloride 10 mg |
| Placebo Memantine Hydrochloride 10 mg | Placebo comparator | Placebo
* Week #1: id (am), 1 caps
* Week #2: bid (am and pm), 2 caps
* Weeks #3-6: 1 caps am \& 2 caps pm, 3 caps
Washout (Weeks #7-8) Memantine Hydrochloride
* Week #9: 5 mg id (am), 1 caps
* Week #10: 5 mg bid (am and pm), 2 caps
* Weeks #11-14: 5 mg am \& 2x 5 mg pm, 3 caps Receives: Drug: Memantine Hydrochloride 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Responder versus Non-Responder Status with Memantine
"Responder" defined as having ≥ 2 of (1) EEG improvement, (2) decreased seizure frequency, (3) cognitive improvement, (4) caregiver impression of improvement, (5) Serum Inflammatory Markers Change. These outcomes are individually defined in detail in the secondary outcomes below.
Description of the primary variable(s) The primary efficacy endpoint is the composite cluster of the first occurrence, over the duration of study (randomization to study end date inclusive), of the EE improvement.
Measured: Week 6 or 14
Rate of Responder versus Non-Responder Status with Placebo
"Responder" defined as having ≥ 2 of (1) EEG improvement, (2) decreased seizure frequency, (3) cognitive improvement, (4) caregiver impression of improvement, (5) Serum Inflammatory Markers Change. These outcomes are individually defined in detail in the secondary outcomes below.
Description of the primary variable(s) The primary efficacy endpoint is the composite cluster of the first occurrence, over the duration of study (randomization to study end date inclusive), of the EE improvement.
Measured: Week 6 or 14
Secondary outcomes (10)
EEG Change with Memantine
EEG improvement EEG Change: EEG is not a quantitative measure, and there are many possible different patterns that may be seen in epileptic encephalopathy. In general, improvement usually involves (a) background activity changing to more closely resemble the expected background activity for the patient's age, and/or (b) decrease in frequency of epileptiform activity. The electroencephalographer will compare EEGs to the baseline study, and will score as (1) Interval worsening, (2) No significant change, or (3) Interval improvement.
We will be assessing all the frequencies usually assessed on a routine EEG (delta, theta, alpha and beta). The frequency range assessed will be 1-70 Hz.
Measured: Week 6 or 14
EEG Change with Placebo
EEG Change: EEG is not a quantitative measure, and there are many possible different patterns that may be seen in epileptic encephalopathy. In general, improvement usually involves (a) background activity changing to more closely resemble the expected background activity for the patient's age, and/or (b) decrease in frequency of epileptiform activity. The electroencephalographer will compare EEGs to the baseline study, and will score as (1) Interval worsening, (2) No significant change, or (3) Interval improvement.
EEG improvement We will be assessing all the frequencies usually assessed on a routine EEG (delta, theta, alpha and beta). The frequency range assessed will be 1-70 Hz.
Measured: Week 6 or 14
Seizure Frequency Change with Memantine
Reduction in seizure frequency Seizure Frequency Change: Participants will keep seizure diaries throughout the study. If the frequency of seizures decreases by > 50% from the baseline frequency, they will be classified as having a significant reduction in seizure frequency.
Measured: Week 6 or 14
Seizure Frequency Change with Placebo
Reduction in seizure frequency Seizure Frequency Change: Participants will keep seizure diaries throughout the study. If the frequency of seizures decreases by > 50% from the baseline frequency, they will be classified as having a significant reduction in seizure frequency.
Measured: Week 6 or 14
Cognitive Function Change with Memantine
Definite improvement in cognitive functioning by neuropsychological testing Cognitive Cognitive Function Change: Participants will see a neuropsychologist at baseline and at the conclusion of each treatment period. The precise testing used will be to the discretion of the neuropsychologist, based on the participant's cognitive capabilities. The neuropsychologist will compare to the baseline assessment and determine if there has been a significant change, based on her experience using these testing protocols in the given age range. The neuropsychologist will score as (1) Interval worsening, (2) No significant change, or (3) Interval improvement.
Measured: Week 6 or 14
Cognitive Function Change with Placebo
Definite improvement in cognitive functioning by neuropsychological testing Cognitive Cognitive Function Change: Participants will see a neuropsychologist at baseline and at the conclusion of each treatment period. The precise testing used will be to the discretion of the neuropsychologist, based on the participant's cognitive capabilities. The neuropsychologist will compare to the baseline assessment and determine if there has been a significant change, based on her experience using these testing protocols in the given age range. The neuropsychologist will score as (1) Interval worsening, (2) No significant change, or (3) Interval improvement.
Measured: Week 6 or 14
Caregiver Impression of Change with Memantine
Subjective perception of improvement by parents Caregiver Impression of Change: At the conclusion of each treatment period, caregivers will be asked the following question: "Compared to before the study, do you feel the overall functioning of your child (including seizure control, development and quality of life) is (1) Improved, (2) No Change, or (3) Worsened.
Measured: Week 6 or 14
Caregiver Impression of Change with Placebo
Subjective perception of improvement by parents Caregiver Impression of Change: At the conclusion of each treatment period, caregivers will be asked the following question: "Compared to before the study, do you feel the overall functioning of your child (including seizure control, development and quality of life) is (1) Improved, (2) No Change, or (3) Worsened.
Measured: Week 6 or 14
Serum Inflammatory Markers Change with Memantine
Changes in serum inflammation Serum inflammatory markers: C Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR) and interleukin-6 (IL-6). CRP and ESR are commonly-used clinical measures of inflammation, and IL-6 was found to be elevated in some epileptic encephalopathies in one study (van den Munckhof et al., 2016). Levels will be compared following each treatment period, to the baseline value.
Measured: Week 6 or 14
Serum Inflammatory Markers Change with Placebo
Changes in serum inflammation Serum inflammatory markers: C Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR) and interleukin-6 (IL-6). CRP and ESR are commonly-used clinical measures of inflammation, and IL-6 was found to be elevated in some epileptic encephalopathies in one study (van den Munckhof et al., 2016). Levels will be compared following each treatment period, to the baseline value.
Measured: Week 6 or 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start7 Feb 2019
- Primary completion8 Nov 2021
- Study completion8 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Epileptic Encephalopathy, Childhood-OnsetStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Monocentric, Off-Label Use, Randomized, crossover, Double-blinded Placebo vs Memantine.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenneth Myers, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kenneth Myers, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779672
- Sponsor's protocol ID
- 22838
- Status last verified
- Mar 2022
- First submitted
- 5 Dec 2018
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van den Munckhof B, de Vries EE, Braun KP, Boss HM, Willemsen MA, van Royen-Kerkhof A, de Jager W, Jansen FE. Serum inflammatory mediators correlate with disease activity in electrical status epilepticus in sleep (ESES) syndrome. Epilepsia. 2016 Feb;57(2):e45-50. doi: 10.1111/epi.13274. Epub 2015 Dec 14.
PubMed 26666401Schiller K, Berrahmoune S, Dassi C, Corriveau I, Ayash TA, Osterman B, Poulin C, Shevell MI, Simard-Tremblay E, Sebire G, Myers KA. Randomized placebo-controlled crossover trial of memantine in children with epileptic encephalopathy. Brain. 2023 Mar 1;146(3):873-879. doi: 10.1093/brain/awac380.
PubMed 36256600
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Placebo-controlled Trial of Memantine Hydrochloride for the Treatment of Childhood-onset Epileptic Encephalopathies
- ClinicalTrials.gov ID
- NCT03779672
- Acronym / sponsor ID
- 22838
- Keywords
- Memantine, N-methyl-D-aspartate receptor, Serum inflammatory, Seizure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kenneth Myers, MDUniversity, hospital or other
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 8 Nov 2021 (actual)
- Study completion
- 8 Feb 2022 (actual)
- First posted
- 19 Dec 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.
This study will evaluate the potential benefit of memantine hydrochloride as treatment for children with epileptic encephalopathy using a double-blind placebo-controlled cross-over design.
Detailed description
Memantine, a drug approved for Alzheimer's dementia, exerts its therapeutic effect through its action as a low to moderate affinity non-competitive (open channel) N-methyl-D-aspartate receptor (NMDA-R) antagonist, which binds preferentially to the NMDA receptor-operated cation channels. It blocks the effects of persistently elevated levels of glutamate that may lead to neuronal dysfunction. Memantine may also have anti-inflammatory effects. Memantine has been used off-label in children and adolescents with autism spectrum disorder, to improve the cognitive impairment.
Epileptic encephalopathy, as well as other forms of epilepsy, may occur as a result of multiple etiologies, including genetic and inflammatory pathologies. Ion channels were long considered to be implicated in genetic epilepsy. Indeed one of the many possible causes of epilepsy is NMDA receptor dysfunction.
In the present study, the investigators plan to investigate the potential benefit of memantine as a treatment for epileptic encephalopathy. A double-blind placebo-controlled cross-over design will be used, with participants receiving 6 weeks of memantine and 6 weeks of placebo, with a 2-week washout period in between.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Monocentric, Off-Label Use, Randomized, crossover, Double-blinded Placebo vs Memantine.
| Arm | Type | Receives |
|---|---|---|
| Memantine Hydrochloride 10 mg Placebo | Active comparator | Drug: Memantine Hydrochloride 10 mgBlue colour capsules, for oral administration, containing 5 mg of active memantine or matching placebo for oral administration. Dose regimen: Memantine Hydrochloride * Week #1: 5 mg id (am), 1 caps * Week #2: 5 mg bid (am and pm), 2 caps * Weeks #3-6: 5 mg am \& 2x 5 mg pm, 3 caps Washout (Weeks #7-8) Placebo * Week #9: id (am), 1 caps * Week #10: bid (am and pm), 2 caps * Weeks #11-14: 1 caps am \& 2 caps pm, 3 caps |
| Placebo Memantine Hydrochloride 10 mg | Placebo comparator | Drug: Memantine Hydrochloride 10 mgPlacebo * Week #1: id (am), 1 caps * Week #2: bid (am and pm), 2 caps * Weeks #3-6: 1 caps am \& 2 caps pm, 3 caps Washout (Weeks #7-8) Memantine Hydrochloride * Week #9: 5 mg id (am), 1 caps * Week #10: 5 mg bid (am and pm), 2 caps * Weeks #11-14: 5 mg am \& 2x 5 mg pm, 3 caps |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Written informed consent obtained
- Age 6-18 years (Weight ≥ 20 kg)
- Clinical diagnosis of epileptic encephalopathy
- Females of childbearing age:
- Negative urinary pregnancy test at screening
Key exclusion criteria (4 listed)
- Inability of a parent or legal guardian to give informed consent for any reason.
- Known hypersensitivity to memantine hydrochloride
- Taking concomitant Amantadine, Ketamine or Dextromethorphan, Cimetidine, Ranitidine, Procainamide, Quinidine, Quinine, Hydrochlorothiazide, Anticholinergics, L-dopa, Anticoagulant,
- Any degree of renal impairment
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 |
|---|---|---|
| Memantine Hydrochloride 10 mgAlso: PrSANDOZ MEMANTINE FCT10 mg Drug Identification Number (DIN) 02375532* Week #1: 5 mg id (am), 1 caps * Week #2: 5 mg bid (am and pm), 2 caps * Weeks #3-6: 5 mg am \& 2x 5 mg pm, 3 caps * Weeks #7-8: Washout Placebo * Week #9: id (am), 1 caps * Week #10: bid (am and pm), 2 caps * Weeks #11-14: 1 caps am \& 2 caps pm, 3 caps OR Placebo * Week #1: id (am), 1 caps * Week #2: bid (am and pm), 2 caps * Weeks #3-6: 1 caps am \& 2 caps pm, 3 caps * Weeks #7-8: Washout Memantine * Week #9: 5 mg id (am), 1 caps * Week #10: 5 mg bid (am and pm), 2 caps * Weeks #11-14: 5 mg am \& 2x 5 mg pm, 3 caps | Drug | Memantine Hydrochloride 10 mg Placebo, Placebo Memantine Hydrochloride 10 mg |
Primary outcome
Rate of Responder versus Non-Responder Status with Memantine
Time frame: Week 6 or 14
"Responder" defined as having ≥ 2 of (1) EEG improvement, (2) decreased seizure frequency, (3) cognitive improvement, (4) caregiver impression of improvement, (5) Serum Inflammatory Markers Change. These outcomes are individually defined in detail in the secondary outcomes below. Description of the primary variable(s) The primary efficacy endpoint is the composite cluster of the first occurrence, over the duration of study (randomization to study end date inclusive), of the EE improvement.
Rate of Responder versus Non-Responder Status with Placebo
Time frame: Week 6 or 14
"Responder" defined as having ≥ 2 of (1) EEG improvement, (2) decreased seizure frequency, (3) cognitive improvement, (4) caregiver impression of improvement, (5) Serum Inflammatory Markers Change. These outcomes are individually defined in detail in the secondary outcomes below. Description of the primary variable(s) The primary efficacy endpoint is the composite cluster of the first occurrence, over the duration of study (randomization to study end date inclusive), of the EE improvement.
10 secondary outcomes
EEG Change with Memantine
Time frame: Week 6 or 14
EEG Change with Placebo
Time frame: Week 6 or 14
Seizure Frequency Change with Memantine
Time frame: Week 6 or 14
Seizure Frequency Change with Placebo
Time frame: Week 6 or 14
Cognitive Function Change with Memantine
Time frame: Week 6 or 14
Cognitive Function Change with Placebo
Time frame: Week 6 or 14
Caregiver Impression of Change with Memantine
Time frame: Week 6 or 14
Caregiver Impression of Change with Placebo
Time frame: Week 6 or 14
Serum Inflammatory Markers Change with Memantine
Time frame: Week 6 or 14
Serum Inflammatory Markers Change with Placebo
Time frame: Week 6 or 14
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 11 Mar 2022.
- Background: PubMed 26666401van den Munckhof B, de Vries EE, Braun KP, Boss HM, Willemsen MA, van Royen-Kerkhof A, de Jager W, Jansen FE. Serum inflammatory mediators correlate with disease activity in electrical status epilepticus in sleep (ESES) syndrome. Epilepsia. 2016 Feb;57(2):e45-50. doi: 10.1111/epi.13274. Epub 2015 Dec 14.
- Derived from this study: PubMed 36256600Schiller K, Berrahmoune S, Dassi C, Corriveau I, Ayash TA, Osterman B, Poulin C, Shevell MI, Simard-Tremblay E, Sebire G, Myers KA. Randomized placebo-controlled crossover trial of memantine in children with epileptic encephalopathy. Brain. 2023 Mar 1;146(3):873-879. doi: 10.1093/brain/awac380.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Memantine Hydrochloride 10 mg in people with Epileptic Encephalopathy, Childhood-Onset, run by Kenneth Myers, MD at 1 site in Canada.
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 4 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 11 Mar 2022. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rate of Responder versus Non-Responder Status with Memantine (time frame: Week 6 or 14). 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 NCT03779672, 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 11 Mar 2022; AzTrials last refreshed its copy on 27 Oct 2026.