Back to resultsA Pilot Trial of Triheptanoin for the Preventive Treatment of Migraine (TRIMI)
Primary Purpose
Migraine
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Triheptanoin
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
treatment arm
Arm Description
pilot-study with single arm of 10 migraine patients treated for 3 months with triheptanoin 1mg/kg/day
Outcomes
Primary Outcome Measures
Change in monthly migraine days
Secondary Outcome Measures
Change in mean attack severity
Change in mean attack duration
Number of patients who have at least a 50% reduction in monthly migraine days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02784847
Brief Title
A Pilot Trial of Triheptanoin for the Preventive Treatment of Migraine
Acronym
TRIMI
Official Title
A Pilot Trial of Triheptanoin for the Preventive Treatment of Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment arm
Arm Type
Other
Arm Description
pilot-study with single arm of 10 migraine patients treated for 3 months with triheptanoin 1mg/kg/day
Intervention Type
Drug
Intervention Name(s)
Triheptanoin
Other Intervention Name(s)
UX007
Intervention Description
Triheptanoin oil administered three times per day during meals at a total dose 1mg/kg/day for 3 months
Primary Outcome Measure Information:
Title
Change in monthly migraine days
Time Frame
Between the 1-month baseline and the 3rd month of triheptanoin treatment
Secondary Outcome Measure Information:
Title
Change in mean attack severity
Time Frame
Between the 1-month baseline and the 3rd month of triheptanoin treatment
Title
Change in mean attack duration
Time Frame
Between the 1-month baseline and the 3rd month of triheptanoin treatment
Title
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
Other Pre-specified Outcome Measures:
Title
Tolerance and gastrointestinal adverse effects
Time Frame
During the 3 months of triheptanoin treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Schoenen, MD, PhD
Phone
+3242238663
Email
jschoenen@ulg.ac.be
First Name & Middle Initial & Last Name or Official Title & Degree
Delphine Magis, MD, PhD
Phone
+3242256111
Email
dmagis@chu.ulg.ac.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Schoenen, MD,PhD
Organizational Affiliation
University Hospital Liège
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Pilot Trial of Triheptanoin for the Preventive Treatment of Migraine
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