A pilot trial to explore if triheptanoin, a natural fatty acid that increasesenergy metabolism in the brain, can prevent migraine attacks.

Phase 1

• Conditions: Migraine; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-001019-19-BE
• Lead Sponsor: IEGE University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-02
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

- Females aged 18-65 years old having an effective contraception, having undergone a bilateral salpingo-oophorectomy or being menopaused, willing and able to fill in the headache diary and to recognize their migraine attacks
- 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- > 4 tension-type headache episodes per month (ICHD-3beta 2.2 & 2.3)
- Medication overuse headache or other headache types (ICHD-3beta 8.2)
- Resistance to >3 previous preventive anti-migraine drug treatments
- Any serious medical or psychiatric condition
- Having a concurrent disease or condition, or laboratory abnormality that, in the view of the Investigator, places the subject at high risk of poor treatment compliance or of not completing the study, or would interfere with study participation or introduces additional safety concerns

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate in a pilot trial the possible therapeutic effect of triheptanoin on frequency of migraine attacks;Secondary Objective: Evaluate the tolerance of tripheptanoin in migraine patients;Primary end point(s): The primary outcome measures will be in concordance with international guidelines (Tfelt-Hansen et al. 2012):<br>- change in monthly migraine days between the 1-month baseline and the 3rd month of triheptanoin treatment <br>- 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<br>;Timepoint(s) of evaluation of this end point: after 3 months of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change in:<br>- monthly migraine days between the 1-month baseline and the average monthly migraine days during the 3 months of triheptanoin treatment<br>- monthly migraine attacks between the 1-month baseline and the 3rd month of triheptanoin treatment<br>- ean attack severity between the 1-month baseline and the 3rd month of triheptanoin treatment<br>- mean attack duration between the 1-month baseline and the 3rd month of triheptanoin treatment<br>- number of migraine days associated with nausea/vomiting between the 1-month baseline and the 3rd month of triheptanoin treatment<br>- number of migraine days associated with photo-/phonophobia between the 1-month baseline and the 3rd month of triheptanoin treatment<br>- monthly intake of acute anti-migraine drugs between the 1-month baseline and the 3rd month of triheptanoin treatment<br><br>and <br><br>- patients’ satisfaction assessed by 2 questions;Timepoint(s) of evaluation of this end point: after 3 months of treatment