Energy for the Brain (MigraKet)
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ClinicalTrials.gov Identifier: NCT03132233 |
Recruitment Status :
Completed
First Posted : April 27, 2017
Last Update Posted : March 27, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Migraine Episodic Migraine | Dietary Supplement: Beta-hydroxybutyrate calcium and magnesium salt Other: placebo powder | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Masking Description: | Double-blind |
Primary Purpose: | Prevention |
Official Title: | Safety, Tolerability and Efficacy of Exogenous Ketone Bodies for Preventive Treatment of Migraine: A Randomised, Placebo-controlled, Double-blind Study |
Actual Study Start Date : | May 8, 2017 |
Actual Primary Completion Date : | January 16, 2020 |
Actual Study Completion Date : | January 31, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Verum
Receives the investigational medicine product (IMP; Beta-hydroxybutyrate calcium and magnesium salt).
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Dietary Supplement: Beta-hydroxybutyrate calcium and magnesium salt
Exogenous ketone body in mineral salt form. |
Placebo Comparator: Placebo
Receives a matched placebo powder to the IMP.
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Other: placebo powder
matched placebo powder to the IMP. |
- 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.
- Number of headache days [ Time Frame: Last 4 weeks of intervention compared to baseline 4 weeks. ]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.
- Acute migraine medication [ Time Frame: Last 4 weeks of intervention compared to baseline 4 weeks. ]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.
- Migraine intensity [ Time Frame: Last 4 weeks of intervention compared to baseline 4 weeks. ]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.
- Migraine Disability Assessment (MIDAS) [ Time Frame: Last 4 weeks of intervention compared to baseline 4 weeks. ]Score in Migraine Disability Assessment (MIDAS; end of baseline versus end of intervention).
- Headache Impact Test (HIT) [ Time Frame: Last 4 weeks of intervention compared to baseline 4 weeks. ]Score in Headache Impact Test (HIT-6; end of baseline versus end of intervention).
- Exploratory biomarker assessments [ Time Frame: Last 4 weeks of intervention compared to baseline 4 weeks. ]Serum concentration changes from baseline of oxidative and nitrosative stress markers (malondialdehyde (MDA), carbonylated proteins, nitrate, nitrite, nitrotyrosine), levels in cytokines, levels in lactate, glucose, insulin and markers of thyroid function. Genetic profile (SNPs) of all patients involved in the study and correlation of the genetic markers with 1-5 using a linear regression model. Gene expression changes before and after diet using expression microarrays with a special focus on mitochondrial related genes (Citrate synthesis, Cytochrom C oxidase subunit 1, Succinate dehydrogenase subunit A). Correlation of gene expression changes with the genetic profile of the patients (eQTL analysis in combination with 1-5 as possible covariates.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132233
Switzerland | |
University Children's Hospital (UKBB) | |
Basel, Basel-Stadt, Switzerland, 4031 |
Principal Investigator: | Dirk Fischer, MD | Professor and head doctor |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University Hospital, Basel, Switzerland |
ClinicalTrials.gov Identifier: | NCT03132233 |
Other Study ID Numbers: |
MigraKet |
First Posted: | April 27, 2017 Key Record Dates |
Last Update Posted: | March 27, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Migraine Prevention Prophylaxis Ketone bodies Beta-hydroxybutyrate Double-blind |
Randomised Placebo controlled Mitochondrial functioning Energy metabolism Intervention Dietary Supplement |
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Calcium Calcium-Regulating Hormones and Agents Physiological Effects of Drugs |