MigraineMigraKetNCT03132233
Energy for the Brain
A study testing Beta-hydroxybutyrate calcium and magnesium salt in people with Migraine and Episodic Migraine, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Approx. one billion people are suffering from migraine worldwide and yet, therapeutic options are still very limited. Research suggests that changes in energy metabolism could be part of migraine pathophysiology. Ketone bodies (KB) are endogenous alternative energy substrates. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine, Episodic Migraine
- What is being tested?
- Beta-hydroxybutyrate calcium and magnesium salt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 May 2017to 31 Jan 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has been previously diagnosed with migraine (with or without aura) in accordance with the ICHD-3 Beta Classification criteria.
- Experience between 5 and 14 migraine days per month (over the last 4 months).
- Has age of onset of migraine less than 50 years old.
- Agrees to refrain from initiating or changing the type, dosage or frequency of any prophylactic medications (exclusive of medications taken for acute relief of migraine symptoms) as well as dietary supplements (such as Q10, riboflavin etc) against migraine and for indications other than migraine that in the opinion of the clinician may interfere with the study objectives (e.g. antidepressant, anticonvulsants, beta blockers, etc.) for the duration of the study.
- Has not changed type, dosage or frequency of any prophylactic medications (exclusive of medications taken for acute relief of migraine symptoms) as well as dietary supplements (such as Q10, riboflavin etc) against migraine and for indications other than migraine that in the opinion of the clinician may interfere with the study objectives (e.g. antidepressant, anticonvulsants, beta blockers, etc.) for at least 3 months prior to study onset.
- Refrains to make any drastic changes to the diet for the duration of the study, including periods of fasting.
- Agrees to use the study intervention as intended, follow all of the requirements of the study including follow-up visit requirements, record required study data in the subject dairy and other self-assessment questionnaires and is okay with drawing blood samples.
- Is able to provide written Informed Consent.
Who cannot join
- Has a concomitant medical condition that will require oral or injectable steroids during the study.
- Has a history of any significant neurological, psychiatric or other medical condition that in the opinion of the investigator may confound the study assessments, liver and kidney diseases in particular.
- Is currently treated for a thyroid disease or has a history thereof.
- Has a cardiovascular disease (hypertension in particular) or a history thereof.
- Has a known history of suspected secondary headache.
- Currently takes simple analgesics or non-steroidal anti-inflammatory drugs (NSAIDs) greater then 14 days per month or triptans greater than 10 days per month for headaches or other body pain.
Show all 16Show fewer
- Currently takes prescription opioids.
- Has previous diagnosis of medication overuse headache (MoH) , which has reverted to episodic migraine within the last 6 months.
- Meets the ICHD-3 Beta Classification criteria for chronic migraine (> 15 headache days per month).
- Has failed an adequate trial (two months or greater) of at least 3 classes of a drug therapy for the prophylaxis of migraine .
- Has had surgery for migraine prevention.
- Has received Botox injections within the last 6 months.
- Is pregnant or thinking of becoming pregnant during the study period, or of childbearing years and is unwilling to use and accepted form of birth control.
- Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
- Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with the follow-up requirements, or provide self- assessments is compromised (e.g. homeless, developmentally disabled and prisoner).
- Is thinking to start, change or stop a hormone-based contraception.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Children's Hospital (UKBB)
Basel, Canton of Basel-City, 4031
About this study
Official title: Safety, Tolerability and Efficacy of Exogenous Ketone Bodies for Preventive Treatment of Migraine: A Randomised, Placebo-controlled, Double-blind Study
Approx. one billion people are suffering from migraine worldwide and yet, therapeutic options are still very limited. Research suggests that changes in energy metabolism could be part of migraine pathophysiology. Ketone bodies (KB) are endogenous alternative energy substrates. Our clinical trial assesses the efficacy and safety of KB supplements in 60-90 adult migraineurs (5-14 migraine days / months) at the University Hospital Basel. The total duration of the trial is approx. 6 months, consisting of 4 weeks baseline, 12 weeks intervention with KB powder or matched placebo and 8 weeks follow-up. The primary endpoint is the change in migraine days at the end of intervention compared to baseline. Additionally, changes in gene expression, fat-, and glucose metabolism, inflammatory markers and quality of life will be examined.
Read the detailed description
Migraine is a complex, common and debilitating neurological disorder. It affects approximately 17% of women and 8% of men in Europe and yet, its primary pathogenic mechanisms are still largely unknown. Various lines of research suggest that brain energy metabolism abnormalities are likely to be part of migraine pathophysiology. Specifically, there is some evidence for reversible abnormalities in mitochondrial functioning in migraine. For example, treatment with riboflavin and coenzyme Q10 has been shown to have migraine protective effects, probably via a positive effect on energy metabolism. Lactic and pyruvic acid, markers of mitochondrial (mt) disease, have been found to be increased in migraineurs; 31P-magnetic resonance spectroscopy (MRS) patterns seen in migraine are consistent with what is seen in mitochondrial disorders; cytochrome oxidase (COX)-negative fibres typical of mt diseases have also been seen in some patients with migraine. A break-down of the resting membrane potential due to lack of adenosine triphosphate (ATP) could explain cortical abnormalities in excitability, which have been reported in migraine. Despite causing a huge amount of suffering and a substantial amount of costs for society current migraine treatment options are limited. None of the prophylactic agents licensed to date are migraine-specific and most are associated with significant- sometimes intolerable- side-effects. Furthermore, their migraine-preventive properties are moderate at most. Hence, there is a need for developing alternative anti-migraine therapies. Several case studies and a first proof of concept study have demonstrated a reduction in migraine attack frequency, severity and use of acute anti-migraine medication during ketosis - with effects sizes ranging from total absence of attacks to a reduction to 1/5th of the run-in period. In addition, preliminary evidence suggests that the migraine-protective effect may outlast the duration of ketosis. This might be a result of longer-lasting gene-expression changes. However, a strict ketogenic diet (KD) is unlikely to provide a feasible long-term solution for episodic migraine patients, because it is difficult to implement in an ambulatory setting and patient adherence may be limited. An alternative means to induce a state of mild to medium nutritional ketosis (0.4-1 mmol/l), irrespective of blood glucose levels, is the dietary supplementation with ketogenic substances, such as beta-hydroxybutyrate (bHB) salts (and unpublished observations). This approach could be easily implemented with intake of a ketogenic powder dissolved in water (consisting of a calcium-magnesium-bHB salt) three times a day (with or after a meal). This nutritional intervention seems much more feasible than a KD in larger patient populations and avoids the complications of a very restricted high-fat diet.
- Conditions
- Migraine, Episodic Migraine
- Being tested
- Beta-hydroxybutyrate calcium and magnesium salt, placebo powder
- Keywords
- Migraine, Prevention, Prophylaxis, Ketone bodies, Beta-hydroxybutyrate, Double-blind, Randomised, Placebo controlled, Mitochondrial functioning, Energy metabolism, Intervention, Dietary Supplement
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-hydroxybutyrate calcium and magnesium saltDietary supplement
Exogenous ketone body in mineral salt form.
placebo powderOther
matched placebo powder to the IMP.
| Study group | Role | What they receive |
|---|---|---|
| Verum | Active comparator | Receives the investigational medicine product (IMP; Beta-hydroxybutyrate calcium and magnesium salt). Receives: Dietary Supplement: Beta-hydroxybutyrate calcium and magnesium salt |
| Placebo | Placebo comparator | Receives a matched placebo powder to the IMP. Receives: Other: placebo powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of migraine days
Mean change from baseline in number of migraine days (meeting International Classification of Headache Disorders (ICHD)-3 criteria) during the last month of intervention in treatment group compared to placebo.
Measured: Last 4 weeks of intervention compared to baseline 4 weeks.
Secondary outcomes (5)
Number of headache days
Mean change from baseline in number of headache days of any severity (meeting ICHD-3 criteria) during the last month of intervention in treatment group compared to placebo.
Measured: Last 4 weeks of intervention compared to baseline 4 weeks.
Acute migraine medication
Mean change from baseline in consumption of acute migraine medication (analgesics or triptans) measured in days with acute headache medication use during the last month of the intervention.
Measured: Last 4 weeks of intervention compared to baseline 4 weeks.
Migraine intensity
Mean change from baseline in migraine intensity (measured with a numerical rating scale from 1-10) during the last of month of the intervention period.
Measured: Last 4 weeks of intervention compared to baseline 4 weeks.
Migraine Disability Assessment (MIDAS)
Score in Migraine Disability Assessment (MIDAS; end of baseline versus end of intervention).
Measured: Last 4 weeks of intervention compared to baseline 4 weeks.
Headache Impact Test (HIT)
Score in Headache Impact Test (HIT-6; end of baseline versus end of intervention).
Measured: Last 4 weeks of intervention compared to baseline 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start8 May 2017
- Primary completion16 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dirk Fischer, MD, Principal investigator, Professor and head doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132233
- Sponsor's protocol ID
- MigraKet
- Acronym
- MigraKet
- Status last verified
- Mar 2020
- First submitted
- 11 Apr 2017
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Putananickal N, Gross EC, Orsini AL, Schmidt S, Hafner P, Gocheva V, Nagy S, Henzi BC, Rubino D, Schadelin S, Sandor P, Fischer D. Metabolic markers of short and long-term exogenous DL-beta-hydroxybutyrate supplementation in episodic migraine patients: an exploratory analysis of a randomized-controlled-trial. Front Pharmacol. 2023 May 4;14:1172483. doi: 10.3389/fphar.2023.1172483. eCollection 2023.
PubMed 37214431Gross EC, Putananickal N, Orsini AL, Schoenen J, Fischer D, Soto-Mota A. Defining metabolic migraine with a distinct subgroup of patients with suboptimal inflammatory and metabolic markers. Sci Rep. 2023 Mar 7;13(1):3787. doi: 10.1038/s41598-023-28499-y.
PubMed 36882474Putananickal N, Gross EC, Orsini AL, Schmidt S, Hafner P, Gocheva V, Nagy S, Henzi BC, Rubino D, Vogt DR, Cichon S, Sandor P, Fischer D. Efficacy and safety of exogenous beta-hydroxybutyrate for preventive treatment in episodic migraine: A single-centred, randomised, placebo-controlled, double-blind crossover trial. Cephalalgia. 2022 Apr;42(4-5):302-311. doi: 10.1177/03331024211043792. Epub 2021 Sep 20.
PubMed 34541914Gross EC, Putananickal N, Orsini AL, Vogt DR, Sandor PS, Schoenen J, Fischer D. Mitochondrial function and oxidative stress markers in higher-frequency episodic migraine. Sci Rep. 2021 Feb 25;11(1):4543. doi: 10.1038/s41598-021-84102-2.
PubMed 33633187Gross E, Putananickal N, Orsini AL, Schmidt S, Vogt DR, Cichon S, Sandor P, Fischer D. Efficacy and safety of exogenous ketone bodies for preventive treatment of migraine: A study protocol for a single-centred, randomised, placebo-controlled, double-blind crossover trial. Trials. 2019 Jan 17;20(1):61. doi: 10.1186/s13063-018-3120-7.
PubMed 30654835
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Efficacy of Exogenous Ketone Bodies for Preventive Treatment of Migraine: A Randomised, Placebo-controlled, Double-blind Study
- ClinicalTrials.gov ID
- NCT03132233
- Acronym / sponsor ID
- MigraKet / MigraKet
- Conditions
- Migraine, Episodic Migraine
- Keywords
- Migraine, Prevention, Prophylaxis, Ketone bodies, Beta-hydroxybutyrate, Double-blind, Randomised, Placebo controlled
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 27 Apr 2017 (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.
Approx. one billion people are suffering from migraine worldwide and yet, therapeutic options are still very limited. Research suggests that changes in energy metabolism could be part of migraine pathophysiology. Ketone bodies (KB) are endogenous alternative energy substrates. Our clinical trial assesses the efficacy and safety of KB supplements in 60-90 adult migraineurs (5-14 migraine days / months) at the University Hospital Basel. The total duration of the trial is approx. 6 months, consisting of 4 weeks baseline, 12 weeks intervention with KB powder or matched placebo and 8 weeks follow-up. The primary endpoint is the change in migraine days at the end of intervention compared to baseline. Additionally, changes in gene expression, fat-, and glucose metabolism, inflammatory markers and quality of life will be examined.
Detailed description
Migraine is a complex, common and debilitating neurological disorder. It affects approximately 17% of women and 8% of men in Europe and yet, its primary pathogenic mechanisms are still largely unknown. Various lines of research suggest that brain energy metabolism abnormalities are likely to be part of migraine pathophysiology. Specifically, there is some evidence for reversible abnormalities in mitochondrial functioning in migraine. For example, treatment with riboflavin and coenzyme Q10 has been shown to have migraine protective effects, probably via a positive effect on energy metabolism. Lactic and pyruvic acid, markers of mitochondrial (mt) disease, have been found to be increased in migraineurs; 31P-magnetic resonance spectroscopy (MRS) patterns seen in migraine are consistent with what is seen in mitochondrial disorders; cytochrome oxidase (COX)-negative fibres typical of mt diseases have also been seen in some patients with migraine. A break-down of the resting membrane potential due to lack of adenosine triphosphate (ATP) could explain cortical abnormalities in excitability, which have been reported in migraine. Despite causing a huge amount of suffering and a substantial amount of costs for society current migraine treatment options are limited. None of the prophylactic agents licensed to date are migraine-specific and most are associated with significant- sometimes intolerable- side-effects. Furthermore, their migraine-preventive properties are moderate at most. Hence, there is a need for developing alternative anti-migraine therapies. Several case studies and a first proof of concept study have demonstrated a reduction in migraine attack frequency, severity and use of acute anti-migraine medication during ketosis - with effects sizes ranging from total absence of attacks to a reduction to 1/5th of the run-in period. In addition, preliminary evidence suggests that the migraine-protective effect may outlast the duration of ketosis. This might be a result of longer-lasting gene-expression changes. However, a strict ketogenic diet (KD) is unlikely to provide a feasible long-term solution for episodic migraine patients, because it is difficult to implement in an ambulatory setting and patient adherence may be limited. An alternative means to induce a state of mild to medium nutritional ketosis (0.4-1 mmol/l), irrespective of blood glucose levels, is the dietary supplementation with ketogenic substances, such as beta-hydroxybutyrate (bHB) salts (and unpublished observations). This approach could be easily implemented with intake of a ketogenic powder dissolved in water (consisting of a calcium-magnesium-bHB salt) three times a day (with or after a meal). This nutritional intervention seems much more feasible than a KD in larger patient populations and avoids the complications of a very restricted high-fat diet.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum | Active comparator | Dietary Supplement: Beta-hydroxybutyrate calcium and magnesium saltReceives the investigational medicine product (IMP; Beta-hydroxybutyrate calcium and magnesium salt). |
| Placebo | Placebo comparator | Other: placebo powderReceives a matched placebo powder to the IMP. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Has been previously diagnosed with migraine (with or without aura) in accordance with the ICHD-3 Beta Classification criteria.
- Experience between 5 and 14 migraine days per month (over the last 4 months).
- Has age of onset of migraine less than 50 years old.
- Agrees to refrain from initiating or changing the type, dosage or frequency of any prophylactic medications (exclusive of medications taken for acute relief of migraine symptoms) as well as dietary supplements (such as Q10, riboflavin etc) against migraine and for indications other than migraine that in the opinion of the clinician may interfere with the study objectives (e.g. antidepressant, anticonvulsants, beta blockers, etc.) for the duration of the study.
- Has not changed type, dosage or frequency of any prophylactic medications (exclusive of medications taken for acute relief of migraine symptoms) as well as dietary supplements (such as Q10, riboflavin etc) against migraine and for indications other than migraine that in the opinion of the clinician may interfere with the study objectives (e.g. antidepressant, anticonvulsants, beta blockers, etc.) for at least 3 months prior to study onset.
Key exclusion criteria (16 listed)
- Has a concomitant medical condition that will require oral or injectable steroids during the study.
- Has a history of any significant neurological, psychiatric or other medical condition that in the opinion of the investigator may confound the study assessments, liver and kidney diseases in particular.
- Is currently treated for a thyroid disease or has a history thereof.
- Has a cardiovascular disease (hypertension in particular) or a history thereof.
- Has a known history of suspected secondary headache.
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 |
|---|---|---|
| Beta-hydroxybutyrate calcium and magnesium saltExogenous ketone body in mineral salt form. | Dietary supplement | Verum |
| placebo powdermatched placebo powder to the IMP. | Other | Placebo |
Primary outcome
Number of migraine days
Time frame: Last 4 weeks of intervention compared to baseline 4 weeks.
Mean change from baseline in number of migraine days (meeting International Classification of Headache Disorders (ICHD)-3 criteria) during the last month of intervention in treatment group compared to placebo.
5 secondary outcomes
Number of headache days
Time frame: Last 4 weeks of intervention compared to baseline 4 weeks.
Acute migraine medication
Time frame: Last 4 weeks of intervention compared to baseline 4 weeks.
Migraine intensity
Time frame: Last 4 weeks of intervention compared to baseline 4 weeks.
Migraine Disability Assessment (MIDAS)
Time frame: Last 4 weeks of intervention compared to baseline 4 weeks.
Headache Impact Test (HIT)
Time frame: Last 4 weeks of intervention compared to baseline 4 weeks.
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 27 Mar 2020.
- Derived from this study: PubMed 37214431Putananickal N, Gross EC, Orsini AL, Schmidt S, Hafner P, Gocheva V, Nagy S, Henzi BC, Rubino D, Schadelin S, Sandor P, Fischer D. Metabolic markers of short and long-term exogenous DL-beta-hydroxybutyrate supplementation in episodic migraine patients: an exploratory analysis of a randomized-controlled-trial. Front Pharmacol. 2023 May 4;14:1172483. doi: 10.3389/fphar.2023.1172483. eCollection 2023.
- Derived from this study: PubMed 36882474Gross EC, Putananickal N, Orsini AL, Schoenen J, Fischer D, Soto-Mota A. Defining metabolic migraine with a distinct subgroup of patients with suboptimal inflammatory and metabolic markers. Sci Rep. 2023 Mar 7;13(1):3787. doi: 10.1038/s41598-023-28499-y.
- Derived from this study: PubMed 34541914Putananickal N, Gross EC, Orsini AL, Schmidt S, Hafner P, Gocheva V, Nagy S, Henzi BC, Rubino D, Vogt DR, Cichon S, Sandor P, Fischer D. Efficacy and safety of exogenous beta-hydroxybutyrate for preventive treatment in episodic migraine: A single-centred, randomised, placebo-controlled, double-blind crossover trial. Cephalalgia. 2022 Apr;42(4-5):302-311. doi: 10.1177/03331024211043792. Epub 2021 Sep 20.
- Derived from this study: PubMed 33633187Gross EC, Putananickal N, Orsini AL, Vogt DR, Sandor PS, Schoenen J, Fischer D. Mitochondrial function and oxidative stress markers in higher-frequency episodic migraine. Sci Rep. 2021 Feb 25;11(1):4543. doi: 10.1038/s41598-021-84102-2.
- Derived from this study: PubMed 30654835Gross E, Putananickal N, Orsini AL, Schmidt S, Vogt DR, Cichon S, Sandor P, Fischer D. Efficacy and safety of exogenous ketone bodies for preventive treatment of migraine: A study protocol for a single-centred, randomised, placebo-controlled, double-blind crossover trial. Trials. 2019 Jan 17;20(1):61. doi: 10.1186/s13063-018-3120-7.
- Study Information VideoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Dirk Fischer, MD principal investigator
Professor and head doctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beta-hydroxybutyrate calcium and magnesium salt in people with Migraine and Episodic Migraine, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 16 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 27 Mar 2020. 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 Switzerland. 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?
Number of migraine days (time frame: Last 4 weeks of intervention compared to baseline 4 weeks.). 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 NCT03132233, which also lists 5 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 27 Mar 2020.