A Pilot Trial of Triheptanoin for the Preventive Treatment of Migraine

Early Phase 1

• Conditions: Migraine
• Interventions: Drug: Triheptanoin

• Registration Number: NCT02784847
• Lead Sponsor: University of Liege

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.

Study Timeline

• Study First Submitted: 2016-03-10
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-24
• Last Update Submitted: 2016-05-24
• Study First Posted: 2016-05-27
• Last Update Posted: 2016-05-27
• Study Start: 2016-06
• Primary Completion: 2016-11
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment arm	Triheptanoin	pilot-study with single arm of 10 migraine patients treated for 3 months with triheptanoin 1mg/kg/day

Primary Outcome Measures

Name	Time	Method
Change in monthly migraine days	Between the 1-month baseline and the 3rd month of triheptanoin treatment

Secondary Outcome Measures

Name	Time	Method
Change in mean attack duration	Between the 1-month baseline and the 3rd month of triheptanoin treatment
Change in mean attack severity	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