Migraine
Conditions
Brief summary
A pilot trial of triheptanoin, a natural compound able to promote anaplerotic mitochondrial metabolism, for the preventative treatment of migraine.
Detailed description
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.
Interventions
DRUGTriheptanoin
Triheptanoin oil administered three times per day during meals at a total dose 1mg/kg/day for 3 months
Sponsors
University of Liege
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Females aged 18-65 years old having an effective contraception or being menopaused * Diagnosis of migraine without aura (ICHD3beta 1.1) since at least 2 years * 4-10 migraine days per month during the last 3 months * No preventive anti-migraine therapy during the last month
Exclusion criteria
* \> 4 tension-type headache episodes per month * Medication overuse headache or other headache types * Resistance to \>3 previous preventive anti-migraine drug treatments * Any serious medical or psychiatric condition * On-going or previous bowel disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in monthly migraine days | Between the 1-month baseline and the 3rd month of triheptanoin treatment |
Secondary
| Measure | 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 |
| 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 |
Other
| Measure | Time frame |
|---|---|
| Tolerance and gastrointestinal adverse effects | During the 3 months of triheptanoin treatment |
Contacts
Primary ContactJean Schoenen, MD, PhD
Backup ContactDelphine Magis, MD, PhD
Outcome results
None listed