Migraine DisordersNCT04553445
Temporal, Environmental, and Genetic Factors Regulating Exercise and Migraine
A study testing Chronotype and Green exercise in people with Migraine Disorders, run by University of Nevada, Las Vegas at 1 site in United States.
Trial summary
Chronic pain, of which migraine is among the most common, affects 100 million US adults and costs between $560 to $635 billion dollars annually. There is a need for effective, low-cost non-pharmacological strategies to reduce migraine load in migraineurs (based on International Headache Society classification… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Chronotype and Green exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2020to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be classified as a chronic migraineur: based on the International Headache Society classification ICHD-3; experience headache (migraine-like or tension-type-like) on 15+ days/month for 3+ months, and have migraine headaches (either with aura or without aura) on 8+ days/month.
- Participants also must also be classified into a discrepant chronotype: screened using the Morningness/Eveningness Questionnaire, into Definite Morning and Morning types; and Definite Evening and Evening types.
Who cannot join
- Not classified as a chronic migraineur.
- Not classified into a discrepant chronotype.
- Not classified as low health risk.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nevada, Las Vegas
Las Vegas, Nevada, 89154
About this study
Chronic pain, of which migraine is among the most common, affects 100 million US adults and costs between $560 to $635 billion dollars annually. There is a need for effective, low-cost non-pharmacological strategies to reduce migraine load in migraineurs (based on International Headache Society classification International Classification of Headache Disorders [ICHD]-3; experience headache [migraine-like or tension-type-like] on 15+ days/month for 3+ months, and have migraine headaches [either with aura or without aura] on 8+ days/month). This represents an area of interest, as common migraine medications induce central nervous system side-effects including aphasia, ataxia, somnolescence, and vertigo; and 79% of suffers have an interest in trying novel treatment strategies with lower adverse effects than medications.
Exercise has been shown to be a non-pharmacological intervention to reduce migraine burden. However, how environmental (i.e. - time-of-day, exposure to nature) and genetic factors (i.e. - polymorphisms in circadian and migraine associated genes) impact the laudatory effects of exercise remains unknown. There are independently established heritable components to migraine frequency (65%), circadian rhythm (70%), and aerobic power during exercise (66%). Thus, the central hypothesis is that an optimal environment can improve the exercise-induced reduction in migraine load, which is influenced by genetic heritability of migraine related gene polymorphisms.
Read the detailed description
Willing participants who are self-reported chronic migraineurs will complete an informed consent followed by a health risk questionnaire to determine study eligibility.
Phase I: Chronic migraineurs will be screened using the Morningness/Eveningness Questionnaire (MEQ) to recruit a cohort of discrepant chronotypes (Definite Morning, Morning; and Evening, Definite Evening). Resulting participants will be complete a baseline migraine load evaluation and assigned to four weeks of moderate intensity exercise (60-70% estimated heart rate max, 2 x per week, 30-min/session) consolidated to either the morning (before 09:00) or afternoon (after 17:00) in a randomized cross-over design. Intensity will be tracked through a heart rate monitor that will be provided to participants, and an application that they can download to their phone. Participants will be able to keep the heart rate monitor upon completion of the study. An example of potential exercises will be provided to participants and research team members will check in every 1-2 weeks to see how exercise is progressing. Migraine burden will be assessed pre- and post-training after each condition using the Migraine Disability Assessment (MIDAS) and the short version of the Headache Impact Test (HIT-6). Half of the participants will exercise for one month during a time of day that is in sync with their chronotype (i.e. Morning type person will exercise in the morning), and the other half of the participants will exercise at a time of day that is not in sync (i.e. Morning type person will exercise in the evening). There will be a one-month wash out period, and then participants will complete training at the other time of day. A buccal swab will be obtained (according to protocols outlined on our approved Institutional Biosafety Committee protocol) for phenotyping of genes specific to chronotype and migraine.
Phase II will also recruit chronic ICHD-3 migraineurs. Participants will complete a baseline migraine load evaluation as described above. If an effect of chronotype is found in Phase I, participants will complete exercise training in sync with their chronotype. Participants will be randomly assigned to four weeks of moderate intensity aerobic exercise (60-70% estimated heart rate max, 2 x per week, 30-min/session) in either natural or indoor environments in a randomized cross-over design. Intensity will be tracked through a heart rate monitor that will be provided to participants, and an application that they can download to their phone. Participants will be able to keep the heart rate monitor upon completion of the study. An example of potential exercises will be provided to participants and research team members will check in every 1-2 weeks to see how exercise is progressing. A recent investigation provided evidence that activity performed in a desert environment provided the same benefits as in a green landscape with respect to both cardiovascular measures as well as perception of comfort, calm, and perceived stress. Half of the participants will exercise for one month in a natural environment that they select (outdoors in a park, or trail) and the other half will complete exercise indoors (participants will not require access to fitness facilities, although these could be used if they are already a member). There will be a one month wash out period, and then participants will complete exercise training in the other setting. Change in the monthly migraine load will be determined between environments. A buccal swab will be obtained for phenotyping of genes specific to chronotype and migraine.
Buccal swab samples will be used to isolate DNA. Isolated DNA will be genotyped at the University of Nevada, Las Vegas (UNLV) Genomics Core Facility using polymerase chain reaction and then disposed of. Genotypes will be linked to participant migraine load responses, and then reported in aggregate.
The investigators plan to maintain regular contact with participants. After each exercise bout, participants will download and email the associated csv file which will be received, deidentified, and labelled with the participant identification number for digital storage at UNLV. In response, participants will be asked about the exercise sessions (with open ended questions such as "How do you feel the exercise sessions are going?"). The file will be reviewed upon receipt by a member of the research team to determine exercise intensity (60-70% estimated heart rate range), allow the investigators to provide feedback, and also enable the determination of how well participants are adhering to the intervention. The investigators will use the Polar Flow application (available for free), which can be deleted by the participant at the end of the study if they so choose.
- Conditions
- Migraine Disorders
- Being tested
- Chronotype, Green exercise
- Keywords
- Chronotype, Green exercise
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChronotypeBehavioural
Participants screened using the Morningness/Eveningness Questionnaire. Chronotype categorized as either Definite Morning/Morning, or Evening/Definite Evening. Participant will exercise (60-70% estimated heart rate max, 2 x per week, 30-min/session) either in sync or not in sync with chronotype for one month in a randomized cross-over design. There will be a one-month wash out period, and then participant will complete training in the alternate chronotype for one month.
Green exerciseBehavioural
Participants will be randomly assigned to four weeks of moderate intensity aerobic exercise (60-70% estimated heart rate max, 2 x per week, 30-min/session) in either natural or indoor environments in a randomized cross-over design. There will be a one-month wash out period, and then participant will complete training in alternate environment for one month.
| Study group | Role | What they receive |
|---|---|---|
| Chronotype | Experimental | Determination whether monthly migraine load is affected by exercise in sync with chronotype Receives: Behavioral: Chronotype |
| Green exercise | Experimental | Determination whether monthly migraine load is affected by exercise in a natural environment Receives: Behavioral: Green exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine load difference (evaluated by MIDAS) when exercising in sync with chronotype versus not in sync
The Migraine Disability Assessment (MIDAS) is a 5 question assessment which asks participants to recall the number of days activities were affected due to migraine: 1) days of work or school missed, 2) days where productivity at work or school was affected, 3) days not completing housework, 4) days where housework productivity was affected by more than half, 5) days missed family, social, or leisure activities. The assessment will be completed before and after one month of exercise completed in sync with chronotype, and before and after exercise is completed not in sync with chronotype. A one month wash out period will separate these months of exercise.
Measured: Three months
Migraine load difference (evaluated by HIT-6) when exercising in sync with chronotype versus not in sync
The Headache Impact Test (HIT-6) is a 6 question assessment which asks participants to rate on a Likert-type scale (Never, Rarely, Sometimes, Very Often, Always) how activities were affected due to migraine: 1) how often headache pain is severe, 2) how often headache limits usual daily activities, 3) how often you wish you could lie down due to headache, 4) how often you felt too tired due to headaches, 5) how often you felt fed up or irritated due to headache, 6) how often headache limited ability to concentrate on work or daily activities. The assessment will be completed before and after one month of exercise completed in sync with chronotype, and before and after exercise is completed not in sync with chronotype. A one month wash out period will separate these months of exercise.
Measured: Three months
Migraine load difference (evaluated by MIDAS) when exercising in nature versus indoors
The Migraine Disability Assessment (MIDAS) is a 5 question assessment which asks participants to recall the number of days activities were affected due to migraine: 1) days of work or school missed, 2) days where productivity at work or school was affected, 3) days not completing housework, 4) days where housework productivity was affected by more than half, 5) days missed family, social, or leisure activities. The assessment will be completed before and after one month of exercise completed in natural environments, and before and after exercise is completed indoors. A one month wash out period will separate these months of exercise.
Measured: Three months
Migraine load difference (evaluated by HIT-6) when exercising in nature versus indoors
The Headache Impact Test (HIT-6) is a 6 question assessment which asks participants to rate on a Likert-type scale (Never, Rarely, Sometimes, Very Often, Always) how activities were affected due to migraine: 1) how often headache pain is severe, 2) how often headache limits usual daily activities, 3) how often you wish you could lie down due to headache, 4) how often you felt too tired due to headaches, 5) how often you felt fed up or irritated due to headache, 6) how often headache limited ability to concentrate on work or daily activities. The assessment will be completed before and after one month of exercise completed in natural environments, and before and after exercise is completed indoors. A one month wash out period will separate these months of exercise.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start23 Nov 2020
- Primary completion31 Mar 2022
- Study completion31 May 2022
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 DisordersStudies 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
- Crossover
- Model description
- Randomized crossover design
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James W Navalta, PhD, Principal investigator, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553445
- Sponsor's protocol ID
- 1607166
- Status last verified
- Nov 2022
- First submitted
- 2 Sep 2020
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results, after deidentification.
Publications
Navalta JW, McGinnis GR, Malek EM. Exercise in a natural environment increases program compliance in people with chronic migraine: A pilot cross-over randomized trial. J Bodyw Mov Ther. 2024 Jul;39:116-121. doi: 10.1016/j.jbmt.2024.02.037. Epub 2024 Mar 6.
PubMed 38876614
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal, Environmental, and Genetic Factors Regulating Exercise and Migraine
- ClinicalTrials.gov ID
- NCT04553445
- Acronym / sponsor ID
- 1607166
- Conditions
- Migraine Disorders
- Keywords
- Chronotype, Green exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 17 Sep 2020 (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.
Chronic pain, of which migraine is among the most common, affects 100 million US adults and costs between $560 to $635 billion dollars annually. There is a need for effective, low-cost non-pharmacological strategies to reduce migraine load in migraineurs (based on International Headache Society classification International Classification of Headache Disorders [ICHD]-3; experience headache [migraine-like or tension-type-like] on 15+ days/month for 3+ months, and have migraine headaches [either with aura or without aura] on 8+ days/month). This represents an area of interest, as common migraine medications induce central nervous system side-effects including aphasia, ataxia, somnolescence, and vertigo; and 79% of suffers have an interest in trying novel treatment strategies with lower adverse effects than medications.
Exercise has been shown to be a non-pharmacological intervention to reduce migraine burden. However, how environmental (i.e. - time-of-day, exposure to nature) and genetic factors (i.e. - polymorphisms in circadian and migraine associated genes) impact the laudatory effects of exercise remains unknown. There are independently established heritable components to migraine frequency (65%), circadian rhythm (70%), and aerobic power during exercise (66%). Thus, the central hypothesis is that an optimal environment can improve the exercise-induced reduction in migraine load, which is influenced by genetic heritability of migraine related gene polymorphisms.
Detailed description
Willing participants who are self-reported chronic migraineurs will complete an informed consent followed by a health risk questionnaire to determine study eligibility.
Phase I: Chronic migraineurs will be screened using the Morningness/Eveningness Questionnaire (MEQ) to recruit a cohort of discrepant chronotypes (Definite Morning, Morning; and Evening, Definite Evening). Resulting participants will be complete a baseline migraine load evaluation and assigned to four weeks of moderate intensity exercise (60-70% estimated heart rate max, 2 x per week, 30-min/session) consolidated to either the morning (before 09:00) or afternoon (after 17:00) in a randomized cross-over design. Intensity will be tracked through a heart rate monitor that will be provided to participants, and an application that they can download to their phone. Participants will be able to keep the heart rate monitor upon completion of the study. An example of potential exercises will be provided to participants and research team members will check in every 1-2 weeks to see how exercise is progressing. Migraine burden will be assessed pre- and post-training after each condition using the Migraine Disability Assessment (MIDAS) and the short version of the Headache Impact Test (HIT-6). Half of the participants will exercise for one month during a time of day that is in sync with their chronotype (i.e. Morning type person will exercise in the morning), and the other half of the participants will exercise at a time of day that is not in sync (i.e. Morning type person will exercise in the evening). There will be a one-month wash out period, and then participants will complete training at the other time of day. A buccal swab will be obtained (according to protocols outlined on our approved Institutional Biosafety Committee protocol) for phenotyping of genes specific to chronotype and migraine.
Phase II will also recruit chronic ICHD-3 migraineurs. Participants will complete a baseline migraine load evaluation as described above. If an effect of chronotype is found in Phase I, participants will complete exercise training in sync with their chronotype. Participants will be randomly assigned to four weeks of moderate intensity aerobic exercise (60-70% estimated heart rate max, 2 x per week, 30-min/session) in either natural or indoor environments in a randomized cross-over design. Intensity will be tracked through a heart rate monitor that will be provided to participants, and an application that they can download to their phone. Participants will be able to keep the heart rate monitor upon completion of the study. An example of potential exercises will be provided to participants and research team members will check in every 1-2 weeks to see how exercise is progressing. A recent investigation provided evidence that activity performed in a desert environment provided the same benefits as in a green landscape with respect to both cardiovascular measures as well as perception of comfort, calm, and perceived stress. Half of the participants will exercise for one month in a natural environment that they select (outdoors in a park, or trail) and the other half will complete exercise indoors (participants will not require access to fitness facilities, although these could be used if they are already a member). There will be a one month wash out period, and then participants will complete exercise training in the other setting. Change in the monthly migraine load will be determined between environments. A buccal swab will be obtained for phenotyping of genes specific to chronotype and migraine.
Buccal swab samples will be used to isolate DNA. Isolated DNA will be genotyped at the University of Nevada, Las Vegas (UNLV) Genomics Core Facility using polymerase chain reaction and then disposed of. Genotypes will be linked to participant migraine load responses, and then reported in aggregate.
The investigators plan to maintain regular contact with participants. After each exercise bout, participants will download and email the associated csv file which will be received, deidentified, and labelled with the participant identification number for digital storage at UNLV. In response, participants will be asked about the exercise sessions (with open ended questions such as "How do you feel the exercise sessions are going?"). The file will be reviewed upon receipt by a member of the research team to determine exercise intensity (60-70% estimated heart rate range), allow the investigators to provide feedback, and also enable the determination of how well participants are adhering to the intervention. The investigators will use the Polar Flow application (available for free), which can be deleted by the participant at the end of the study if they so choose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized crossover design
| Arm | Type | Receives |
|---|---|---|
| Chronotype | Experimental | Behavioral: ChronotypeDetermination whether monthly migraine load is affected by exercise in sync with chronotype |
| Green exercise | Experimental | Behavioral: Green exerciseDetermination whether monthly migraine load is affected by exercise in a natural environment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants must be classified as a chronic migraineur: based on the International Headache Society classification ICHD-3; experience headache (migraine-like or tension-type-like) on 15+ days/month for 3+ months, and have migraine headaches (either with aura or without aura) on 8+ days/month.
- Participants also must also be classified into a discrepant chronotype: screened using the Morningness/Eveningness Questionnaire, into Definite Morning and Morning types; and Definite Evening and Evening types.
Key exclusion criteria (3 listed)
- Not classified as a chronic migraineur.
- Not classified into a discrepant chronotype.
- Not classified as low health risk.
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 |
|---|---|---|
| ChronotypeParticipants screened using the Morningness/Eveningness Questionnaire. Chronotype categorized as either Definite Morning/Morning, or Evening/Definite Evening. Participant will exercise (60-70% estimated heart rate max, 2 x per week, 30-min/session) either in sync or not in sync with chronotype for one month in a randomized cross-over design. There will be a one-month wash out period, and then participant will complete training in the alternate chronotype for one month. | Behavioural | Chronotype |
| Green exerciseParticipants will be randomly assigned to four weeks of moderate intensity aerobic exercise (60-70% estimated heart rate max, 2 x per week, 30-min/session) in either natural or indoor environments in a randomized cross-over design. There will be a one-month wash out period, and then participant will complete training in alternate environment for one month. | Behavioural | Green exercise |
Primary outcome
Migraine load difference (evaluated by MIDAS) when exercising in sync with chronotype versus not in sync
Time frame: Three months
The Migraine Disability Assessment (MIDAS) is a 5 question assessment which asks participants to recall the number of days activities were affected due to migraine: 1) days of work or school missed, 2) days where productivity at work or school was affected, 3) days not completing housework, 4) days where housework productivity was affected by more than half, 5) days missed family, social, or leisure activities. The assessment will be completed before and after one month of exercise completed in sync with chronotype, and before and after exercise is completed not in sync with chronotype. A one month wash out period will separate these months of exercise.
Migraine load difference (evaluated by HIT-6) when exercising in sync with chronotype versus not in sync
Time frame: Three months
The Headache Impact Test (HIT-6) is a 6 question assessment which asks participants to rate on a Likert-type scale (Never, Rarely, Sometimes, Very Often, Always) how activities were affected due to migraine: 1) how often headache pain is severe, 2) how often headache limits usual daily activities, 3) how often you wish you could lie down due to headache, 4) how often you felt too tired due to headaches, 5) how often you felt fed up or irritated due to headache, 6) how often headache limited ability to concentrate on work or daily activities. The assessment will be completed before and after one month of exercise completed in sync with chronotype, and before and after exercise is completed not in sync with chronotype. A one month wash out period will separate these months of exercise.
Migraine load difference (evaluated by MIDAS) when exercising in nature versus indoors
Time frame: Three months
The Migraine Disability Assessment (MIDAS) is a 5 question assessment which asks participants to recall the number of days activities were affected due to migraine: 1) days of work or school missed, 2) days where productivity at work or school was affected, 3) days not completing housework, 4) days where housework productivity was affected by more than half, 5) days missed family, social, or leisure activities. The assessment will be completed before and after one month of exercise completed in natural environments, and before and after exercise is completed indoors. A one month wash out period will separate these months of exercise.
Migraine load difference (evaluated by HIT-6) when exercising in nature versus indoors
Time frame: Three months
The Headache Impact Test (HIT-6) is a 6 question assessment which asks participants to rate on a Likert-type scale (Never, Rarely, Sometimes, Very Often, Always) how activities were affected due to migraine: 1) how often headache pain is severe, 2) how often headache limits usual daily activities, 3) how often you wish you could lie down due to headache, 4) how often you felt too tired due to headaches, 5) how often you felt fed up or irritated due to headache, 6) how often headache limited ability to concentrate on work or daily activities. The assessment will be completed before and after one month of exercise completed in natural environments, and before and after exercise is completed indoors. A one month wash out period will separate these months of exercise.
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 28 Nov 2022.
- Derived from this study: PubMed 38876614Navalta JW, McGinnis GR, Malek EM. Exercise in a natural environment increases program compliance in people with chronic migraine: A pilot cross-over randomized trial. J Bodyw Mov Ther. 2024 Jul;39:116-121. doi: 10.1016/j.jbmt.2024.02.037. Epub 2024 Mar 6.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results, after deidentification.
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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.
James W Navalta, PhD principal investigator
University of Nevada, Las Vegas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronotype and Green exercise in people with Migraine Disorders, run by University of Nevada, Las Vegas at 1 site in United States.
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 3 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 28 Nov 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 United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine load difference (evaluated by MIDAS) when exercising in sync with chronotype versus not in sync (time frame: Three months). The study lists 4 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 NCT04553445, 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 28 Nov 2022.