A Pilot Trial of Triheptanoin for the Preventive Treatment of Migraine (TRIMI)

A pilot trial of triheptanoin, a natural compound able to promote anaplerotic mitochondrial metabolism, for the preventative treatment of migraine.

Study Overview

• Status: Unknown
• Conditions: Migraine
• Intervention / Treatment: Drug: Triheptanoin

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Delphine Magis, MD, PhD; Phone Number: +3242256111; Email: dmagis@chu.ulg.ac.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: treatment arm; pilot-study with single arm of 10 migraine patients treated for 3 months with triheptanoin 1mg/kg/day	Drug: Triheptanoin; Triheptanoin oil administered three times per day during meals at a total dose 1mg/kg/day for 3 months; Other Names: UX007

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in monthly migraine days	Between the 1-month baseline and the 3rd month of triheptanoin treatment

Secondary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Tolerance and gastrointestinal adverse effects	During the 3 months of triheptanoin treatment

Collaborators and Investigators

• Sponsor: University of Liege
• Investigators: Principal Investigator: Jean Schoenen, MD,PhD, University Hospital Liege

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ANTICIPATED): November 1, 2016
• Study Completion (ANTICIPATED): November 1, 2016

Study Registration Dates

• First Submitted: March 10, 2016
• First Submitted That Met QC Criteria: May 24, 2016
• First Posted (ESTIMATE): May 27, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): May 27, 2016
• Last Update Submitted That Met QC Criteria: May 24, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: UX007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO