CancerPhase 3MIR-PNCT04763135
Mirtazapine in Cancer-related Poly-symptomatology
A Phase 3 study testing Mirtazapine and Escitalopram in people with Cancer and Neoplasms, run by Hospices Civils de Lyon at 11 sites in France.
Trial summary
Multicenter, prospective, randomized, controlled trial based on a mixed-method methodology using parallel groups, of oral mirtazapine (intervention) compared with oral escitalopram (control), with a 56 days follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Neoplasms, Neoplasm Metastasis
- What is being tested?
- Mirtazapine and Escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 11 sitesFrance
- Study dates
- 15 Dec 2021to 17 Dec 2021
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over 18 years old
- Suffering from advanced cancer
- Having a clinically estimated life expectancy over 3 months.
- Being diagnosed from having a depressive syndrome by a Hospital Anxiety and Depression Scale-D over 11.
- Being in need of an antidepressant treatment.
- Suffering from at least one under-controlled symptom (defined as a score over 3 on the Edmonton Symptom Assessment Scale) among: pain, nausea, vomiting, breathlessness, lack of appetite, sleep disorders, anxiety or impaired wellbeing.
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- Having or not a cancer treatment.
- Being able to understand the information related to the study, and to sign informed consent.
- Having agreed to take part to the study.
- Being able to fill Patient Reported Outcomes questionnaires.
- Being available to be call on days 7 and 14.
- Having a social security affiliation.
Who cannot join
- Being treated by an antidepressive agent during the four weeks before inclusion.
- Having had a hypersensitivity event to mirtazapine, escitalopram of any excipient.
- Having had a prior inefficient treatment by mirtazapine or escitalopram.
- Having postural hypotension or arterial systolic hypotension inferior to 90 mmHg measured following the guidelines of the European Society of Cardiology
- Having a QT interval over 420 ms.
- Having uncontrolled hearth rhythm disorder or uncontrolled conduction disorder.
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- Having had or having bipolar disorder.
- Having uncontrolled seizure or epilepsy (relative non-inclusion criteria needing a neurology specialist opinion)
- Having or having history of closed-angle glaucoma.
- Having bone marrow aplasia.
- Practicing breast-feeding or being pregnant.
- Women of childbearing age with no contraception method.
- Having a treatment with:
- Monoamine oxidase inhibitors (Selegiline, Moclobemide, Isocarboxazid, Nialamide, Phenelzine, Tranylcypromine, Iproniazid, Iproclozide, Toloxatone, Linezolid, Safinamide, Rasagiline)
- One of the following antiarrhythmic drugs: Flecainide, Propafenone, any class IA and III antiarrhythmic drug (amiodarone, disopyramide, hydroquinidine, quinidine, procainamide, sparteine, ajmaline, prajmaline, lorajmine, bretylium tosilate, bunaftine, dofetilide, ibutilide, tedisamil, dronedarone).
- Linezolid, sparfloxacin, moxifloxacin, macrolides (IV erythromycin, josamycin, clarithromycin, telithromycin), pentamidin, halofantrine, HIV protease inhibitors (ritonavir, nelfinavir, amprenavir, indinavir), azolic antifungal agents (ketoconazole, itraconazole, miconazole, fluconazole, voriconazole)
- Mizolastine and Astémizole
- St. John's wort
- Having genetic galactose intolerance or glucose-galactose malabsorption.
- Having one of the following electrolyte disorders not corrected at the time of inclusion: hyponatremia, hyperkalemia, hypokalemia, hypermagnesemia, and hypomagnesemia.
- Having end-stage renal disease with a creatinine clearance inferior to 15 ml/min calculated using the Cockroft's formula.
- Having hepatic failure.
- Having legal incapacity
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Centre Hospitalier Universitaire de Clermont-Ferrand
Cébazat, 63118
Centre Hospitalier Universitaire de Grenoble
La Tronche, 38700
Hôpital Edouard Herriot
Lyon, 69003
Hôpital de la Croix-Rousse
Lyon, 69004
Centre Médico-Chirurgical de Réadaptation des Massues Croix-Rouge française
Lyon, 69005
Centre Léon Bérard
Lyon, 69008
Institut Curie
Paris, 75005
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, 42100
Hôpitaux universitaires de Strasbourg
Strasbourg, 67098
Centre Hospitalier de Valence
Valence, 26000
About this study
Official title: What is the Effectiveness and Safety of Mirtazapine Versus Escitalopram in Alleviating Cancer-associated Poly-symptomatology (MIR-P)? A Mixed-method Randomized Controlled Trial Protocol
Multicenter, prospective, randomized, controlled trial based on a mixed-method methodology using parallel groups, of oral mirtazapine (intervention) compared with oral escitalopram (control), with a 56 days follow-up. Improvement of the Global health Status (issued from the EORTC-QLQ-C30 (Quality of Life Questionnaire)) will be used as the primary outcome on day 56. Semi-structures interviews will be performed on a purposive sample for qualitative analysis. The 418 participants will be followed-up at day 7, 14, 28 and 56 for a 56 days period. A sub-group of participants will be invited to take part into qualitative interviews at baseline and day 56. Recruitment of participants to the qualitative part will be based on a purposive sampling.
- Conditions
- Cancer, Neoplasms, Neoplasm Metastasis
- Being tested
- Mirtazapine, Escitalopram
- Keywords
- Cancer, Symptom management, Poly-Symptomatology, Mirtazapine, Antidepressive drugs
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirtazapineDrug
Orally disintegrating tablets of mirtazapine introduced at the dose of 15 mg and increased up to 45 mg per day during 56 days.
Doses escalation: based on symptom management and side effect assessment.
EscitalopramDrug
Orally disintegrating tablets of escitalopram introduced at the dose of 10 mg (or 5 mg for patients older than 65) and increased up to 20 mg per day during 56 days.
Doses escalation: based on symptom management and side effect assessment.
| Study group | Role | What they receive |
|---|---|---|
| Oral mirtazapine | Experimental | Arm 1 patients will be treated using a daily mirtazapine treatment. Treatment will be taken on the evening. Treatment will be initiated at 15 mg daily and gradually increased depending on symptom control and side effects. Treatment doses will be adapted for old patients and those with liver failure. Receives: Drug: Mirtazapine |
| Oral escitalopram | Active comparator | Arm 2 patients will be treated using a daily escitalopram treatment. Treatment will be taken in the morning. Treatment will be initiated at 10 mg daily and gradually increased depending on symptom control and side effects. Treatment doses will be adapted for 5 mg for old patients. Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global health status score
The Global Health Status will be calculated from the specific subscale included in the EORTC-QLQ-C30 scale.
The difference between baseline and the end-point (day 56) will be the primary judgment criteria. A 4 to 8 points difference between baseline and endpoint will be considered as a mild difference, and a difference over 8 points will be considered as a moderate difference.
Measured: At baseline and day 56
Secondary outcomes (22)
The subjective experience associated with symptoms burden.
Qualitative analysis of compared semi-structured interviews undertaken at baseline and day 56 on a convenience sample.
Measured: At baseline and day 56.
Proportion of mitigated symptoms.
The Edmonton Symptom Assessment Scale 12F will be used to assess each symptoms intensities for the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness.
For each symptom, the difference between baseline and the assessment time will be calculated. A difference equal or over one point will be regarded as mitigation. The judgment criteria will be the proportion of symptoms that were rated over three at baseline and that were mitigated at the assessment time.
Measured: Day 28
Proportion of mitigated symptoms.
The Edmonton Symptom Assessment Scale 12F will be used to assess each symptoms intensities for the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness.
For each symptom, the difference between baseline and the assessment time will be calculated. A difference equal or over one point will be regarded as mitigation. The judgment criteria will be the proportion of symptoms that were rated over three at baseline and that were mitigated at the assessment time.
Measured: Day 56
Auto-assessment depression score.
The Hospital Anxiety and Depression Scale-D auto-assessment score will be used to assess the auto-assessment depression score.
The judgment criteria will be the difference between baseline and the assessment time. A difference over 1.5 points will be regarded as clinically significant.
Measured: Day 28
Auto-assessment depression score.
The Hospital Anxiety and Depression Scale-D auto-assessment score will be used to assess the auto-assessment depression score.
The judgment criteria will be the difference between baseline and the assessment time. A difference over 1.5 points will be regarded as clinically significant.
Measured: Day 56
Hetero-assessment-based depression score.
The Montgomery-Asberg Depression Rating Scale hetero-assessment score will be used to assess the hetero-assessment depression score.
The judgment criteria will be the difference between baseline and the assessment time. A difference over 1.9 points will be regarded as clinically significant.
Measured: Day 28
Hetero-assessment-based depression score.
The Montgomery-Asberg Depression Rating Scale hetero-assessment score will be used to assess the hetero-assessment depression score.
The judgment criteria will be the difference between baseline and the assessment time. A difference over 1.9 points will be regarded as clinically significant.
Measured: Day 56
Weight control
Weight control will be defined as a difference under 500g between the weight at baseline minus the weight at the assessment time.
The judgment criteria will be the proportion of patients with weight control at assessment time.
Measured: Day 28
Weight control
Weight control will be defined as a difference under 500g between the weight at baseline minus the weight at the assessment time.
The judgment criteria will be the proportion of patients with weight control at assessment time.
Measured: Day 56
Weight improvement.
Weight improvement will be defined as a difference over 500g between the weight at the assessment time minus the weight at baseline.
The judgment criteria will be the proportion of patients with weight improvement at assessment time.
Measured: Day 28
Weight improvement.
Weight improvement will be defined as a difference over 500g between the weight at the assessment time minus the weight at baseline.
The judgment criteria will be the proportion of patients with weight improvement at assessment time.
Measured: Day 56
Stability in oral morphine milligram equivalents.
The stability in oral morphine milligrams equivalent will be defined as a decrease or stability in the daily doses of opioid pain killers measured using oral morphine milligram equivalents.
The judgment criteria will be the proportion of patients with stability in oral morphine milligram equivalents.
Measured: Day 28
Stability in oral morphine milligram equivalents.
The stability in oral morphine milligrams equivalent will be defined as a decrease or stability in the daily doses of opioid pain killers measured using oral morphine milligram equivalents.
The judgment criteria will be the proportion of patients with stability in oral morphine milligram equivalents.
Measured: Day 56
Escalation in symptom control treatment doses
Escalation in symptom control treatment doses will be defined as any escalation in the dose of a treatment existing at baseline or any new treatment introduced to control one of the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness.
The judgment criteria will be the proportion of patients with an escalation in symptom control treatment doses.
Measured: Day 28
Escalation in symptom control treatment doses
Escalation in symptom control treatment doses will be defined as any escalation in the dose of a treatment existing at baseline or any new treatment introduced to control one of the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness.
The judgment criteria will be the proportion of patients with an escalation in symptom control treatment doses.
Measured: Day 56
Number of side effects.
The number of side effects will be used to assess the security of use. It will be assessed using the Antidepressant Side Effect Checklist and side effects will be considered if rated moderate or severe.
Measured: Day 7
Number of side effects.
The number of side effects will be used to assess the security of use. It will be assessed using the Antidepressant Side Effect Checklist and side effects will be considered if rated moderate or severe.
Measured: Day 14
Number of side effects.
The number of side effects will be used to assess the security of use. It will be assessed using the Antidepressant Side Effect Checklist and side effects will be considered if rated moderate or severe.
Measured: Day 28
Number of side effects.
The number of side effects will be used to assess the security of use. It will be assessed using the Antidepressant Side Effect Checklist and side effects will be considered if rated moderate or severe.
Measured: Day 56
Medication adherence.
The medication adherence will be assessed using the Medication Adherence Rating Scale score at day 56 and the Proportion of Days Covered all along the follow-up period.
Measured: Day 56
Symptoms' intensities auto-assessment on the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness.
The Edmonton Symptom Assessment Scale 12F will be used to assess each symptoms intensities for the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness.
For each symptom, the difference between baseline and the assessment time will be used as the judgment criteria. A difference equal or over one point will be regarded as clinically significant.
Measured: Day 28
Symptoms' intensities auto-assessment on the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness.
The Edmonton Symptom Assessment Scale 12F will be used to assess each symptoms intensities for the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness.
For each symptom, the difference between baseline and the assessment time will be used as the judgment criteria. A difference equal or over one point will be regarded as clinically significant.
Measured: Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start15 Dec 2021
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
Why it stopped: difficulties in recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume ECONOMOS, MD, Principal investigator, Centre Hospitalier Lyon Sud - Service de Soins Palliatifs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763135
- Sponsor's protocol ID
- 69HCL20_0032
- Other IDs
- 2020-002994-90
- Acronym
- MIR-P
- Status last verified
- Jun 2023
- First submitted
- 15 Feb 2021
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Economos G, Alexandre M, Perceau-Chambard E, Villeneuve L, Subtil F, Haesebaert J, Glehen O. What is the effectiveness and safety of mirtazapine versus escitalopram in alleviating cancer-associated poly-symptomatology (the MIR-P study)? A mixed-method randomized controlled trial protocol. BMC Palliat Care. 2022 May 23;21(1):84. doi: 10.1186/s12904-022-00976-7.
PubMed 35599320
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Effectiveness and Safety of Mirtazapine Versus Escitalopram in Alleviating Cancer-associated Poly-symptomatology (MIR-P)? A Mixed-method Randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT04763135
- Acronym / sponsor ID
- MIR-P / 69HCL20_0032
- Conditions
- Cancer, Neoplasms, Neoplasm Metastasis
- Keywords
- Cancer, Symptom management, Poly-Symptomatology, Mirtazapine, Antidepressive drugs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulties in recruiting
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 21 Feb 2021 (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.
Multicenter, prospective, randomized, controlled trial based on a mixed-method methodology using parallel groups, of oral mirtazapine (intervention) compared with oral escitalopram (control), with a 56 days follow-up. Improvement of the Global health Status (issued from the EORTC-QLQ-C30 (Quality of Life Questionnaire)) will be used as the primary outcome on day 56. Semi-structures interviews will be performed on a purposive sample for qualitative analysis. The 418 participants will be followed-up at day 7, 14, 28 and 56 for a 56 days period. A sub-group of participants will be invited to take part into qualitative interviews at baseline and day 56. Recruitment of participants to the qualitative part will be based on a purposive sampling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral mirtazapine | Experimental | Drug: MirtazapineArm 1 patients will be treated using a daily mirtazapine treatment. Treatment will be taken on the evening. Treatment will be initiated at 15 mg daily and gradually increased depending on symptom control and side effects. Treatment doses will be adapted for old patients and those with liver failure. |
| Oral escitalopram | Active comparator | Drug: EscitalopramArm 2 patients will be treated using a daily escitalopram treatment. Treatment will be taken in the morning. Treatment will be initiated at 10 mg daily and gradually increased depending on symptom control and side effects. Treatment doses will be adapted for 5 mg for old patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Being over 18 years old
- Suffering from advanced cancer
- Having a clinically estimated life expectancy over 3 months.
- Being diagnosed from having a depressive syndrome by a Hospital Anxiety and Depression Scale-D over 11.
- Being in need of an antidepressant treatment.
Key exclusion criteria (23 listed)
- Being treated by an antidepressive agent during the four weeks before inclusion.
- Having had a hypersensitivity event to mirtazapine, escitalopram of any excipient.
- Having had a prior inefficient treatment by mirtazapine or escitalopram.
- Having postural hypotension or arterial systolic hypotension inferior to 90 mmHg measured following the guidelines of the European Society of Cardiology
- Having a QT interval over 420 ms.
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 |
|---|---|---|
| MirtazapineOrally disintegrating tablets of mirtazapine introduced at the dose of 15 mg and increased up to 45 mg per day during 56 days. Doses escalation: based on symptom management and side effect assessment. | Drug | Oral mirtazapine |
| EscitalopramOrally disintegrating tablets of escitalopram introduced at the dose of 10 mg (or 5 mg for patients older than 65) and increased up to 20 mg per day during 56 days. Doses escalation: based on symptom management and side effect assessment. | Drug | Oral escitalopram |
Primary outcome
Global health status score
Time frame: At baseline and day 56
The Global Health Status will be calculated from the specific subscale included in the EORTC-QLQ-C30 scale. The difference between baseline and the end-point (day 56) will be the primary judgment criteria. A 4 to 8 points difference between baseline and endpoint will be considered as a mild difference, and a difference over 8 points will be considered as a moderate difference.
22 secondary outcomes
The subjective experience associated with symptoms burden.
Time frame: At baseline and day 56.
Proportion of mitigated symptoms.
Time frame: Day 28
Proportion of mitigated symptoms.
Time frame: Day 56
Auto-assessment depression score.
Time frame: Day 28
Auto-assessment depression score.
Time frame: Day 56
Hetero-assessment-based depression score.
Time frame: Day 28
Hetero-assessment-based depression score.
Time frame: Day 56
Weight control
Time frame: Day 28
Weight control
Time frame: Day 56
Weight improvement.
Time frame: Day 28
Weight improvement.
Time frame: Day 56
Stability in oral morphine milligram equivalents.
Time frame: Day 28
Stability in oral morphine milligram equivalents.
Time frame: Day 56
Escalation in symptom control treatment doses
Time frame: Day 28
Escalation in symptom control treatment doses
Time frame: Day 56
Number of side effects.
Time frame: Day 7
Number of side effects.
Time frame: Day 14
Number of side effects.
Time frame: Day 28
Number of side effects.
Time frame: Day 56
Medication adherence.
Time frame: Day 56
Symptoms' intensities auto-assessment on the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness.
Time frame: Day 28
Symptoms' intensities auto-assessment on the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness.
Time frame: Day 56
Results and safety
The study was stopped early (reason given: difficulties in recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Derived from this study: PubMed 35599320Economos G, Alexandre M, Perceau-Chambard E, Villeneuve L, Subtil F, Haesebaert J, Glehen O. What is the effectiveness and safety of mirtazapine versus escitalopram in alleviating cancer-associated poly-symptomatology (the MIR-P study)? A mixed-method randomized controlled trial protocol. BMC Palliat Care. 2022 May 23;21(1):84. doi: 10.1186/s12904-022-00976-7.
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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.
Guillaume ECONOMOS, MD principal investigator
Centre Hospitalier Lyon Sud - Service de Soins Palliatifs
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mirtazapine and Escitalopram in people with Cancer and Neoplasms, run by Hospices Civils de Lyon at 11 sites in France.
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 12 inclusion and 23 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: stopped early, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. 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?
The study was stopped early (reason given: difficulties in recruiting). Results are not available in the source record.
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?
Global health status score (time frame: At baseline and day 56). 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 NCT04763135, 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 8 Jun 2023.