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A pilot trial of triheptanoin, a natural compound able to promote anaplerotic mitochondrial metabolism, for the preventative treatment of migraine.
To test the ability of a daily 3-month treatment with triheptanoin to prevent migraine attacks in 10 migraine patients.
This is an open, non-randomized pilot trial that might justify a placebo-controlled trial, if there are at least 50% of patients with ≥50% reduction in attack frequency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm | Other | pilot-study with single arm of 10 migraine patients treated for 3 months with triheptanoin 1mg/kg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triheptanoin | Drug | Triheptanoin oil administered three times per day during meals at a total dose 1mg/kg/day for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in monthly migraine days | Between the 1-month baseline and the 3rd month of triheptanoin treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean attack severity | Between the 1-month baseline and the 3rd month of triheptanoin treatment | |
| Change in mean attack duration | Between the 1-month baseline and the 3rd month of triheptanoin treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance and gastrointestinal adverse effects | During the 3 months of triheptanoin treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean Schoenen, MD, PhD | Contact | +3242238663 | jschoenen@ulg.ac.be | |
| Delphine Magis, MD, PhD | Contact | +3242256111 | dmagis@chu.ulg.ac.be |
| Name | Affiliation | Role |
|---|---|---|
| Jean Schoenen, MD,PhD | University Hospital Liège | Principal Investigator |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C531010 | triheptanoin |
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| Number of patients who have at least a 50% reduction in monthly migraine days | Between the 1-month baseline and the 3rd month of triheptanoin treatment |
| D009422 | Nervous System Diseases |