Migraine Without AuraNCT02765581
Efficacy Study of Acupuncture in the Prevention of Migraine Without Aura
A study testing Verum acupuncture in people with Migraine Without Aura, run by Wei Wang at 1 site in China.
Trial summary
Acupuncture is commonly used for the prevention of migraine, while the evidence for its efficacy is still uncertain. Current studies have not been able to determine whether the efficacy of acupuncture is due to the actual therapeutic effect of acupuncture, or a result of psychological benefits. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Migraine Without Aura
- What is being tested?
- Verum acupuncture
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2016to 20 Nov 2018
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed as migraine without aura according to the International Classification of Headache Disorders,3rd edition beta version (ICHD-3β);
- Aged between 15 and 65 years old, with initial onset of migraines before the age of 50 years; and
- Experienced migraine attacks for at least 1 year; and
- Experienced migraine attacks with 2-8 times per month during the last 3 months and baseline period, and the duration of migraine attacks lasting 4-72h without intake of acute drugs or at least 2h with intake of acute drugs; and
- the mean headache Visual Analogue Scale (VAS) scores 4-8 at baseline; and
- Had not taken any acupuncture treatment before study entry; and
- Able to complete the baseline headache diary; and
- Able to signing a informed consent.
Who cannot join
- Tension-type headache, cluster headache, and other primary headache disorders, secondary headache disorders, neuralgia of the face or head; and
- Combined with cardiovascular, liver, kidney, gastrointestinal tract, blood system and other serious primary diseases affecting the implementation of treatment programs, or combined with epilepsy, Parkinson or other nervous system diseases; and
- Patients with severe mental illness, such as severe anxiety and depression; and
- Pregnant women, women in lactation, and those planning to become pregnant; and
- Participation in other clinical trials; and
- Illiterate, or patients unable to read and understand scales;
- Have experience of acupuncture.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei
About this study
Official title: Evaluating the Prophylactic Efficacy of Acupuncture for Migraine Without Aura (MWoA) : A Randomized Controlled Trial
Acupuncture is commonly used for the prevention of migraine, while the evidence for its efficacy is still uncertain. Current studies have not been able to determine whether the efficacy of acupuncture is due to the actual therapeutic effect of acupuncture, or a result of psychological benefits. To address this issue, we designed a clinical trial to evaluate the prophylactic efficacy of acupuncture for migraine without aura (MWoA). Furthermore, we will evaluate the impact of Chinese medicine factors and psychological factors on the efficacy of acupuncture.
Read the detailed description
This is a multicentre, stratified, randomized, sham-controlled clinical trial. 150 eligible participants will be randomly allocated into verum acupuncture, sham acupuncture, or usual care groups, in a 2:2:1 ratio. The verum acupuncture group will receive twenty verum acupuncture treatments over an eight-week period, while the sham acupuncture group will receive sham acupuncture treatments with non-penetrating needling. Participants assigned to the usual care group are scheduled to receive twenty verum acupuncture treatments for free after waiting 24 weeks. Health education will be provided to participants in the three groups. The primary outcomes will be the changes in the mean number of migraine days and migraine attacks per four-week cycle. The secondary outcomes will be as follows: the proportion of responders, migraine intensity, migraine disability assessment questionnaire, health-related and sleep-related quality of life, the dose of intake of acute medication. Chinese medicine factors will include de qi sensations and Traditional Chinese Medicine (TCM) constitution. Psychological outcomes will include anxiety, depression, personality, expectancy about acupuncture, and doctor-patient relationship. The central randomization and data collection will be conducted by an electronic data management system.
- Conditions
- Migraine Without Aura
- Being tested
- Verum acupuncture, Sham acupuncture, Usual care
- Keywords
- Acupuncture, Migraine without aura, Efficacy, Randomized controlled trial, Non-penetrating sham acupuncture
- Medical subject headings
- Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum acupunctureDevice
The main acupuncture points are bilateral "Hegu" (L14) and "Taichong" (LR3), unilateral "Taiyang"(EX-HN5), "Fengchi" (GB20) and "Shuaigu" (GB8). Additional points can be chosen according to individual syndrome differentiation of meridians: (1) Yangming headache: Touwei (ST8); (2) Taiyang headache: Tianzhu (BL10); (3) Jueying: Baihui" (GV20). The NO.16 special type of acupuncture (0.30 x 30 mm) produced by German asia-med company will be applied.The needles will be inserted into the skin of acupuncture points and manipulated manually by using the techniques such as lifting, thrusting, and twirling, until the internal compound sensation known as deqi.
Sham acupunctureDevice
We use a non-insertive sham control produced by Asia-med Company in Germany-the streitberger placebo-needle. Sham points are described as follows: 1) Bilateral of midpoint between acupoint "Jianjin"(GB21) and "Jugu"(LI16); 2) 5 cun lateral to the seventh thoracic spine; 3) 5 cun lateral to the eighth thoracic spine; 4) 5 cun lateral to the ninth thoracic spine. Cun is a distance measure unit used in locating acupoints in traditional Chinese medicine (TCM) acupuncture, and the width of patient's thumb interphalangeal joint is regarded as one cun.
Usual careBehavioural
Health education is provided in three aspects: lifestyle changes, behavioral therapies and migraine self-management.
| Study group | Role | What they receive |
|---|---|---|
| Verum acupuncture (VA) | Experimental | Participants will be treated by verum acupuncture and usual care. They will be treated every other day to fulfill a 10-session treatment course, and another course will begin after resting 9 days. Each acupuncture treatment session for patients will be 30 minutes in duration. Receives: Device: Verum acupuncture; Behavioral: Usual care |
| Sham acupuncture (SA) | Sham comparator | Participants will be treated by sham acupuncture and usual care. They will be treated every other day to fulfill a 10-session treatment course, and another course will begin after resting 9 days. Each acupuncture treatment session for patients will be 30 minutes in duration. Receives: Device: Sham acupuncture; Behavioral: Usual care |
| Usual care (UA) | Placebo comparator | Participants will undergo a clinical interview once a month, complete the headache diary assessment, have counseling and health education, and rescue medication if necessary. In addition, they will be scheduled to receive 20 sessions of verum acupuncture treatments for free after a waiting period of 24 weeks. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of migraine days
The changes in the mean number of migraine days per 4-week cycle
Measured: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization.
Change in the frequency of migraine attacks
The changes in the mean number of migraine attacks per 4-week cycle
Measured: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization.
Secondary outcomes (8)
The proportion of responders
The proportion of patients with at least a 50% reduction of the number of migraine days
Measured: At weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization.
Change in visual analogue scale
The changes in the mean visual analogue scale scores per 4-week cycle
Measured: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization.
Change in Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2).
The changes in the scores of Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2) per 4-week cycle
Measured: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization.
Change in Migraine Disability Assessment questionnaire(MIDAS).
The changes in the scores of Migraine Disability Assessment questionnaire(MIDAS)
Measured: At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization.
Change in Migraine-Specific Quality of Life Questionnaire(MSQ) Version 2.1.
The changes in the scores of Migraine-Specific Quality of Life Questionnaire(MSQ) per 4-week cycle
Measured: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization.
Change in 36-Item Short-Form Health Survey(SF-36).
The changes in the scores of 36-Item Short-Form Health Survey(SF-36) per 4-week cycle
Measured: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization.
Change in Pittsburgh Sleep Quality Index(PSQI).
The changes in the scores of Pittsburgh Sleep Quality Index(PSQI) per 4-week cycle
Measured: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization.
Change in the dose of intake of acute medication.
The changes in the dose of intake of acute medication per 4-week cycle
Measured: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study start1 May 2016
- Primary completion20 Nov 2018
- Study completion20 Nov 2018
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 Migraine Without AuraStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wei Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Hubei College of Traditional Chinese Medicine, Hubei Hospital of Traditional Chinese Medicine, Wuhan Integrated Traditional Chinese and Western Medicine Hospital, University Hospital of Huang Jia Lake Campus, Hubei University of Chinese Medicine, The Second Hospital of Huangshi, Xiangyang No.1 People's Hospital, Hubei University of Medicine
- Responsible party
- Sponsor-investigator, Wei Wang, Huazhong University of Science and Technology
- Investigators
- Wei Wang, Doctor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765581
- Sponsor's protocol ID
- 201403RCTMWA
- Status last verified
- Sep 2019
- First submitted
- 10 Apr 2016
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xu S, Yu L, Luo X, Wang M, Chen G, Zhang Q, Liu W, Zhou Z, Song J, Jing H, Huang G, Liang F, Wang H, Wang W. Manual acupuncture versus sham acupuncture and usual care for prophylaxis of episodic migraine without aura: multicentre, randomised clinical trial. BMJ. 2020 Mar 25;368:m697. doi: 10.1136/bmj.m697.
PubMed 32213509
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Prophylactic Efficacy of Acupuncture for Migraine Without Aura (MWoA) : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02765581
- Acronym / sponsor ID
- 201403RCTMWA
- Conditions
- Migraine Without Aura
- Keywords
- Acupuncture, Migraine without aura, Efficacy, Randomized controlled trial, Non-penetrating sham acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Wei WangUniversity, hospital or other
- Collaborators
- Hubei College of Traditional Chinese Medicine, Hubei Hospital of Traditional Chinese Medicine, Wuhan Integrated Traditional Chinese and Western Medicine Hospital, University Hospital of Huang Jia Lake Campus, Hubei University of Chinese Medicine, The Second Hospital of Huangshi, Xiangyang No.1 People's Hospital, Hubei University of Medicine
- Study start
- 1 May 2016 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 6 May 2016 (estimated)
- 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.
Acupuncture is commonly used for the prevention of migraine, while the evidence for its efficacy is still uncertain. Current studies have not been able to determine whether the efficacy of acupuncture is due to the actual therapeutic effect of acupuncture, or a result of psychological benefits. To address this issue, we designed a clinical trial to evaluate the prophylactic efficacy of acupuncture for migraine without aura (MWoA). Furthermore, we will evaluate the impact of Chinese medicine factors and psychological factors on the efficacy of acupuncture.
Detailed description
This is a multicentre, stratified, randomized, sham-controlled clinical trial. 150 eligible participants will be randomly allocated into verum acupuncture, sham acupuncture, or usual care groups, in a 2:2:1 ratio. The verum acupuncture group will receive twenty verum acupuncture treatments over an eight-week period, while the sham acupuncture group will receive sham acupuncture treatments with non-penetrating needling. Participants assigned to the usual care group are scheduled to receive twenty verum acupuncture treatments for free after waiting 24 weeks. Health education will be provided to participants in the three groups. The primary outcomes will be the changes in the mean number of migraine days and migraine attacks per four-week cycle. The secondary outcomes will be as follows: the proportion of responders, migraine intensity, migraine disability assessment questionnaire, health-related and sleep-related quality of life, the dose of intake of acute medication. Chinese medicine factors will include de qi sensations and Traditional Chinese Medicine (TCM) constitution. Psychological outcomes will include anxiety, depression, personality, expectancy about acupuncture, and doctor-patient relationship. The central randomization and data collection will be conducted by an electronic data management system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Verum acupuncture (VA) | Experimental | Device: Verum acupuncture, Behavioral: Usual careParticipants will be treated by verum acupuncture and usual care. They will be treated every other day to fulfill a 10-session treatment course, and another course will begin after resting 9 days. Each acupuncture treatment session for patients will be 30 minutes in duration. |
| Sham acupuncture (SA) | Sham comparator | Device: Sham acupuncture, Behavioral: Usual careParticipants will be treated by sham acupuncture and usual care. They will be treated every other day to fulfill a 10-session treatment course, and another course will begin after resting 9 days. Each acupuncture treatment session for patients will be 30 minutes in duration. |
| Usual care (UA) | Placebo comparator | Behavioral: Usual careParticipants will undergo a clinical interview once a month, complete the headache diary assessment, have counseling and health education, and rescue medication if necessary. In addition, they will be scheduled to receive 20 sessions of verum acupuncture treatments for free after a waiting period of 24 weeks. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed as migraine without aura according to the International Classification of Headache Disorders,3rd edition beta version (ICHD-3β);
- Aged between 15 and 65 years old, with initial onset of migraines before the age of 50 years; and
- Experienced migraine attacks for at least 1 year; and
- Experienced migraine attacks with 2-8 times per month during the last 3 months and baseline period, and the duration of migraine attacks lasting 4-72h without intake of acute drugs or at least 2h with intake of acute drugs; and
- the mean headache Visual Analogue Scale (VAS) scores 4-8 at baseline; and
Key exclusion criteria (7 listed)
- Tension-type headache, cluster headache, and other primary headache disorders, secondary headache disorders, neuralgia of the face or head; and
- Combined with cardiovascular, liver, kidney, gastrointestinal tract, blood system and other serious primary diseases affecting the implementation of treatment programs, or combined with epilepsy, Parkinson or other nervous system diseases; and
- Patients with severe mental illness, such as severe anxiety and depression; and
- Pregnant women, women in lactation, and those planning to become pregnant; and
- Participation in other clinical trials; and
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 |
|---|---|---|
| Verum acupunctureThe main acupuncture points are bilateral "Hegu" (L14) and "Taichong" (LR3), unilateral "Taiyang"(EX-HN5), "Fengchi" (GB20) and "Shuaigu" (GB8). Additional points can be chosen according to individual syndrome differentiation of meridians: (1) Yangming headache: Touwei (ST8); (2) Taiyang headache: Tianzhu (BL10); (3) Jueying: Baihui" (GV20). The NO.16 special type of acupuncture (0.30 x 30 mm) produced by German asia-med company will be applied.The needles will be inserted into the skin of acupuncture points and manipulated manually by using the techniques such as lifting, thrusting, and twirling, until the internal compound sensation known as deqi. | Device | Verum acupuncture (VA) |
| Sham acupunctureWe use a non-insertive sham control produced by Asia-med Company in Germany-the streitberger placebo-needle. Sham points are described as follows: 1) Bilateral of midpoint between acupoint "Jianjin"(GB21) and "Jugu"(LI16); 2) 5 cun lateral to the seventh thoracic spine; 3) 5 cun lateral to the eighth thoracic spine; 4) 5 cun lateral to the ninth thoracic spine. Cun is a distance measure unit used in locating acupoints in traditional Chinese medicine (TCM) acupuncture, and the width of patient's thumb interphalangeal joint is regarded as one cun. | Device | Sham acupuncture (SA) |
| Usual careHealth education is provided in three aspects: lifestyle changes, behavioral therapies and migraine self-management. | Behavioural | Sham acupuncture (SA), Usual care (UA), Verum acupuncture (VA) |
Primary outcome
Change in the number of migraine days
Time frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization.
The changes in the mean number of migraine days per 4-week cycle
Change in the frequency of migraine attacks
Time frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization.
The changes in the mean number of migraine attacks per 4-week cycle
8 secondary outcomes
The proportion of responders
Time frame: At weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization.
Change in visual analogue scale
Time frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization.
Change in Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2).
Time frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization.
Change in Migraine Disability Assessment questionnaire(MIDAS).
Time frame: At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization.
Change in Migraine-Specific Quality of Life Questionnaire(MSQ) Version 2.1.
Time frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization.
Change in 36-Item Short-Form Health Survey(SF-36).
Time frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization.
Change in Pittsburgh Sleep Quality Index(PSQI).
Time frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization.
Change in the dose of intake of acute medication.
Time frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization.
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 9 Sep 2019.
- Derived from this study: PubMed 32213509Xu S, Yu L, Luo X, Wang M, Chen G, Zhang Q, Liu W, Zhou Z, Song J, Jing H, Huang G, Liang F, Wang H, Wang W. Manual acupuncture versus sham acupuncture and usual care for prophylaxis of episodic migraine without aura: multicentre, randomised clinical trial. BMJ. 2020 Mar 25;368:m697. doi: 10.1136/bmj.m697.
- Individual participant dataSharing planned: Undecided
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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.
Wei Wang, Doctor principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum acupuncture in people with Migraine Without Aura, run by Wei Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 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 9 Sep 2019. 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 China. 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.
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?
Change in the number of migraine days (time frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization.). 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 NCT02765581, 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 9 Sep 2019.