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

U

University of Liege

Status and phase

Unknown
Early Phase 1

Conditions

Migraine

Treatments

Drug: Triheptanoin

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

10 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

treatment arm
Other group
Description:
pilot-study with single arm of 10 migraine patients treated for 3 months with triheptanoin 1mg/kg/day
Treatment:
Drug: Triheptanoin

Trial contacts and locations

0

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Central trial contact

Jean Schoenen, MD, PhD; Delphine Magis, MD, PhD

Data sourced from clinicaltrials.gov

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