MigrainePhase 3NCT02959190
A Study of LY2951742 (Galcanezumab) in Japanese Participants With Migraine
A Phase 3 study testing Galcanezumab in people with Migraine, run by Eli Lilly and Company at 44 sites in Japan.
Trial summary
The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as Galcanezumab in Japanese participants with migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Galcanezumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 44 sitesJapan
- Study dates
- 7 Feb 2017to 10 Aug 2019
- 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
- For Episodic Migraine participants: Participants who completed the treatment period of Galcanezumab study CGAN.
- Have a diagnosis of chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.
Who cannot join
- For Chronic Migraine participants:
- Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.
- Current use or prior exposure to Galcanezumab or other antibodies of calcitonin gene-related peptide (CGRP) or its receptor.
- Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to Galcanezumab and the excipients in the investigational product.
- History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.
- Failure to respond to 3 or more adequately dosed migraine preventive treatments from different classes (that is, maximum tolerated dose for at least 2 months).
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
Japan44 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chofu-shi, 182-0006
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Fukui, 918 8503
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Fukuoka, 816 0824
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Higashiosaka, 578-8588
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Hiroshima, 730-0031
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Ibaraki, 300-1206
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Iruma-Gun, 350-0495
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Kagawa, 769-0103
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Kagoshima, 892-0842
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Kagoshima, 892-0844
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Kaisho, 400-0124
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Kanoya, 893-0032
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Kasaoka-shi, 714-0043
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Kasuga-shi, 816-0802
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Kobe, 658-0064
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Kochi, 780-0051
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Kochi, 780-8011
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Kyoto, 600-8811
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Kyoto, 606-0851
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Minatoku, 108-8642
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Morioka, 020-0034
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Morioka, 020-8505
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Narashino-shi, 275-0026
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Nishinomiya, 663-8014
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Nishinomiya, 663-8204
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Ōita, 870-0831
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Okayama, 700-8557
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Osaka, 556-0015
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Ōsaka, 560-0012
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Ōta-ku, 145-0063
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Ota-shi, 373-8585
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Saijo-shi, 793-0030
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Saitama, 338-8577
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Sapporo, 003-0003
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Sapporo, 060-8570
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Sendai
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Shibuya-ku, 151-0051
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Shinjuku-ku, 160-0017
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Shizuoka, 420-0853
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Tachikawa-shi, 190-8531
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Tochigi, 321-0207
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Tochigi, 321-0293
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Tokyo, 160-8582
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Yamaguchi, 754-0002
About this study
Official title: A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 (Galcanezumab) in Japanese Patients With Migraine
The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as Galcanezumab in Japanese participants with migraine.
- Conditions
- Migraine
- Being tested
- Galcanezumab
- Keywords
- prevention, prophylaxis, headache
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GalcanezumabDrug
Also called LY2951742
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| 120mg/120mg Galcanezumab - Episodic Migraine (EM) | Experimental | 240 milligram (loading dose) of Galcanezumab at first dosing visit followed by 120 milligram (mg) once a month for a year by subcutaneous (SC) injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab. Receives: Drug: Galcanezumab |
| 240mg/240mg Galcanezumab - EM | Experimental | 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab. Receives: Drug: Galcanezumab |
| Placebo/ 120mg Galcanezumab - EM | Experimental | 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo. Receives: Drug: Galcanezumab |
| Placebo/ 240mg Galcanezumab - EM | Experimental | 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo. Receives: Drug: Galcanezumab |
| 120mg Galcanezumab - CM | Experimental | 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled. Receives: Drug: Galcanezumab |
| 240mg Galcanezumab - CM | Experimental | 240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled. Receives: Drug: Galcanezumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.
Measured: Up To 16 Months
Secondary outcomes (12)
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Serum Concentration of Galcanezumab at month 12 is reported.
Measured: Month 12: Predose
Pharmacodynamics (PD): Plasma Concentration of Total Calcitonin Gene-Related Peptide (CGRP)
Plasma Concentration of total CGRP at month 12 is reported.
Measured: Month 12: Predose
Percentage of Participants Developing Anti-Drug Antibodies (ADA)
Treatment emergent ADA will be defined as any of the following:
A negative baseline result and a positive post-baseline ADA result with a titer ≥20. This is also called treatment-induced ADA.
A positive baseline result and a positive post-baseline ADA result with a ≥4-fold increase in titers (for example, baseline titer of 10 increasing to ≥40 post-baseline). This is called treatment-boosted ADA.
Measured: Month 0, 1, 2, 3, 6, 9, 12 and 16: Predose; Month 0 and 14 days Postdose
Mean Change From Baseline in the Number of Migraine Headache Days (MHDs)
Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred.
Migraine Headache (EM Participants): A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B): A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia.
Migraine Headache (CM Participants) : A headache, with or without aura, of greater than or equal to (≥30) minutes duration which meets criteria A and B or meets criterion C: A and B criteria as described above and criteria C) The headache is believed by the participant to be migraine at onset and is relieved by a triptan or ergot derivative.
Measured: Baseline, Month 12
Mean Change From Baseline in the Number of Headache Days (HDs)
A headache day is calendar day on which any type of headache occurs,(including migraine headache, probable migraine headache, and non-migraine headache).
Measured: Baseline, Month 12
Percentage of Participants With Meeting Criteria for Reductions From Baseline Greater Than or Equal to (≥) 50% in Number of Migraine Headache Days
Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. A 50% responder in a particular month is any participant who has a ≥50% reduction from baseline in the monthly number of migraine headache attacks in a 30-day interval.
Measured: Month 12
Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine Headache
Migraine Headache Day (MHD) with Acute Medication Use: Calendar days on which migraine or probable migraine occurs, requiring acute medication.
Measured: Baseline, Month 12
Mean Change From Baseline in the Number of Monthly Migraine Headache Days or Headache Days Requiring Medication for the Acute Treatment of Migraine Headache or Headache
Monthly Migraine Headache Days or Headache Days Requiring Medication for the Acute Treatment of Migraine Headache or Headache: Calendar days on which headache, migraine or probable migraine occurs, requiring acute medication.
Measured: Baseline, Month 12
Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score
The PGI-S scale is a patient-rated instrument that measures patients own global impression of their illness severity. The patient was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options were from 1 ("normal, not at all ill") to 7 ("extremely ill").
Measured: Baseline, Month 12
Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score
The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability.
Measured: Baseline, Month 12
Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1
MSQ version 2.1 is a health status instrument,with a 4-week recall period,developed to address physical \& emotional limitations of specific concern to individuals with migraine.Addressing the impact of migraine on work or daily activities,relationships with family \& friends,leisure time,productivity,concentration, energy,tiredness \& feelings.It consists of 14 items addressing 3 domains:(1)Role Function-Restrictive (items 1-7);(2)Role Function- Preventive (items 8-11);\&(3)Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6), \& are reverse-recoded (value 6 to 1) before the domain scores are calculated.Total raw scores for each domain is the sum of the final item value for all of the items in that domain.After total raw score is computed for each domain \& total score, they are transformed to a 0-100 scale with higher scores indicating a better health status \& a positive change in scores reflecting functional improvement.
Measured: Baseline, Month 12
Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)
The PSMQ-M is a self-rated scale which measures participants level of satisfaction with study medication.The scale has been modified for use in this study, assessing 3 items related to the clinical trial treatment over the past 4 weeks: satisfaction, preference, and side effects.Satisfaction responses range from "very unsatisfied" to "very satisfied" with the current treatment (5 categories). Preference compared the current study medication to previous medications, with responses from "much rather prefer my previous medication" to "much rather prefer the medication administered to me during the study" (5 categories). The side effects responses range from "significantly less side effects" to "significantly more side effects" (5 categories). Positive responses for each item were defined as follows: Satisfaction: "Very Satisfied" or "Somewhat Satisfied"; Preference: "Much Prefer Study Medication" or "Prefer Study Medication"; Side Effects: "Much-Less Side Effects" or "Less Side Effects".
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study start7 Feb 2017
- Primary completion10 Aug 2019
- Study completion10 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959190
- Sponsor's protocol ID
- 16108
- Other IDs
- I5Q-JE-CGAP
- Status last verified
- Aug 2019
- First submitted
- 7 Nov 2016
- Last updated
- 29 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
Takeshima T, Doi H, Ooba S, Tanji Y, Ozeki A, Komori M. Clinical Evaluation After Discontinuation of Galcanezumab in Japanese Patients with Episodic and Chronic Migraine: Analysis of a Randomized, Placebo-Controlled Trial and Open-label Extension Study. Neurol Ther. 2024 Jun;13(3):697-714. doi: 10.1007/s40120-024-00602-z. Epub 2024 Apr 6.
PubMed 38581615Hirata K, Takeshima T, Sakai F, Tatsuoka Y, Suzuki N, Igarashi H, Nakamura T, Ozeki A, Yamazaki H, Skljarevski V. A long-term open-label safety study of galcanezumab in Japanese patients with migraine. Expert Opin Drug Saf. 2021 Jun;20(6):721-733. doi: 10.1080/14740338.2021.1866536. Epub 2021 Jan 4.
PubMed 33393835
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 (Galcanezumab) in Japanese Patients With Migraine
- ClinicalTrials.gov ID
- NCT02959190
- Acronym / sponsor ID
- 16108
- Conditions
- Migraine
- Keywords
- prevention, prophylaxis, headache
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 10 Aug 2019 (actual)
- Study completion
- 10 Aug 2019 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Posted 24 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as Galcanezumab in Japanese participants with migraine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 120mg/120mg Galcanezumab - Episodic Migraine (EM) | Experimental | Drug: Galcanezumab240 milligram (loading dose) of Galcanezumab at first dosing visit followed by 120 milligram (mg) once a month for a year by subcutaneous (SC) injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab. |
| 240mg/240mg Galcanezumab - EM | Experimental | Drug: Galcanezumab240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab. |
| Placebo/ 120mg Galcanezumab - EM | Experimental | Drug: Galcanezumab240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo. |
| Placebo/ 240mg Galcanezumab - EM | Experimental | Drug: Galcanezumab240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo. |
| 120mg Galcanezumab - CM | Experimental | Drug: Galcanezumab240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled. |
| 240mg Galcanezumab - CM | Experimental | Drug: Galcanezumab240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- For Episodic Migraine participants: Participants who completed the treatment period of Galcanezumab study CGAN.
- Have a diagnosis of chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.
Key exclusion criteria (6 listed)
- For Chronic Migraine participants:
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 |
|---|---|---|
| GalcanezumabAlso: LY2951742Administered SC | Drug | 120mg Galcanezumab - CM, 120mg/120mg Galcanezumab - Episodic Migraine (EM), 240mg Galcanezumab - CM, 240mg/240mg Galcanezumab - EM, Placebo/ 120mg Galcanezumab - EM, Placebo/ 240mg Galcanezumab - EM |
Primary outcome
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up To 16 Months
A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.
12 secondary outcomes
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Time frame: Month 12: Predose
Pharmacodynamics (PD): Plasma Concentration of Total Calcitonin Gene-Related Peptide (CGRP)
Time frame: Month 12: Predose
Percentage of Participants Developing Anti-Drug Antibodies (ADA)
Time frame: Month 0, 1, 2, 3, 6, 9, 12 and 16: Predose; Month 0 and 14 days Postdose
Mean Change From Baseline in the Number of Migraine Headache Days (MHDs)
Time frame: Baseline, Month 12
Mean Change From Baseline in the Number of Headache Days (HDs)
Time frame: Baseline, Month 12
Percentage of Participants With Meeting Criteria for Reductions From Baseline Greater Than or Equal to (≥) 50% in Number of Migraine Headache Days
Time frame: Month 12
Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine Headache
Time frame: Baseline, Month 12
Mean Change From Baseline in the Number of Monthly Migraine Headache Days or Headache Days Requiring Medication for the Acute Treatment of Migraine Headache or Headache
Time frame: Baseline, Month 12
Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score
Time frame: Baseline, Month 12
Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score
Time frame: Baseline, Month 12
Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1
Time frame: Baseline, Month 12
Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)
Time frame: Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38581615Takeshima T, Doi H, Ooba S, Tanji Y, Ozeki A, Komori M. Clinical Evaluation After Discontinuation of Galcanezumab in Japanese Patients with Episodic and Chronic Migraine: Analysis of a Randomized, Placebo-Controlled Trial and Open-label Extension Study. Neurol Ther. 2024 Jun;13(3):697-714. doi: 10.1007/s40120-024-00602-z. Epub 2024 Apr 6.
- Derived from this study: PubMed 33393835Hirata K, Takeshima T, Sakai F, Tatsuoka Y, Suzuki N, Igarashi H, Nakamura T, Ozeki A, Yamazaki H, Skljarevski V. A long-term open-label safety study of galcanezumab in Japanese patients with migraine. Expert Opin Drug Saf. 2021 Jun;20(6):721-733. doi: 10.1080/14740338.2021.1866536. Epub 2021 Jan 4.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
44 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 Galcanezumab in people with Migraine, run by Eli Lilly and Company at 44 sites in Japan.
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 2 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 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Japan. 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 24 Aug 2020). 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?
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Up To 16 Months). 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 NCT02959190, 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 29 Sep 2020.