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

May 24, 2016 updated by: Jean Schoenen, University of Liege
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Between the 1-month baseline and the 3rd month of triheptanoin treatment
Between the 1-month baseline and the 3rd month of triheptanoin treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in mean attack severity
Time Frame: Between the 1-month baseline and the 3rd month of triheptanoin treatment
Between the 1-month baseline and the 3rd month of triheptanoin treatment
Change in mean attack duration
Time Frame: Between the 1-month baseline and the 3rd month of triheptanoin treatment
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
Time Frame: Between the 1-month baseline and the 3rd month of triheptanoin treatment
Between the 1-month baseline and the 3rd month of triheptanoin treatment

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • UX007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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