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TRIMI: A Pilot Trial of Triheptanoin for the Preventive Treatment of Migraine

Sponsor
University of Liege (Other)
Overall Status
Unknown status
CT.gov ID
NCT02784847
Collaborator
(none)
10
Enrollment
1
Arm
5
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Trial of Triheptanoin for the Preventive Treatment of Migraine
Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Nov 1, 2016
Anticipated Study Completion Date :
Nov 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in monthly migraine days [Between the 1-month baseline and the 3rd month of triheptanoin treatment]

    Secondary Outcome Measures

    1. Change in mean attack severity [Between the 1-month baseline and the 3rd month of triheptanoin treatment]

    2. Change in mean attack duration [Between the 1-month baseline and the 3rd month of triheptanoin treatment]

    3. 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

    1. Tolerance and gastrointestinal adverse effects [During the 3 months of triheptanoin treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Liege

    Investigators

    • Principal Investigator: Jean Schoenen, MD,PhD, University Hospital Liège

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jean Schoenen, Honorary Professor, University of Liege
    ClinicalTrials.gov Identifier:
    NCT02784847
    Other Study ID Numbers:
    • UX007
    First Posted:
    May 27, 2016
    Last Update Posted:
    May 27, 2016
    Last Verified:
    May 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Migraine Disorders

    Study Results

    No Results Posted as of May 27, 2016