A Pilot Trial of Triheptanoin for the Preventive Treatment of Migraine

Migraine Clinical Trial

— TRIMI  

Official title:

A Pilot Trial of Triheptanoin for the Preventive Treatment of Migraine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02784847
• Other study ID #: UX007
• Status: Not yet recruiting
• Phase: Phase 0
• First received: March 10, 2016
• Last updated: May 24, 2016
• Start date: June 2016
• Est. completion date: November 2016

Study information

• Verified date: May 2016
• Source: University Hospital of Liege
• Contact: Jean Schoenen, MD, PhD
• Phone: +3242238663
• Email: jschoenen[@]ulg.ac.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Triheptanoin
Triheptanoin oil administered three times per day during meals at a total dose 1mg/kg/day for 3 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tolerance and gastrointestinal adverse effects		During the 3 months of triheptanoin treatment	Yes
Primary	Change in monthly migraine days		Between the 1-month baseline and the 3rd month of triheptanoin treatment	No
Secondary	Change in mean attack severity		Between the 1-month baseline and the 3rd month of triheptanoin treatment	No
Secondary	Change in mean attack duration		Between the 1-month baseline and the 3rd month of triheptanoin treatment	No
Secondary	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	No