A Pilot Trial of Triheptanoin for the Preventive Treatment of Migraine

NCT ID: NCT02784847

Last Updated: 2016-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Migraine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment arm

pilot-study with single arm of 10 migraine patients treated for 3 months with triheptanoin 1mg/kg/day

Group Type OTHER

Triheptanoin

Intervention Type DRUG

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

Interventions

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Triheptanoin

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

Intervention Type DRUG

Other Intervention Names

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UX007

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Jean Schoenen

Honorary Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean Schoenen, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Liège

Central Contacts

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Jean Schoenen, MD, PhD

Role: CONTACT

+3242238663

Delphine Magis, MD, PhD

Role: CONTACT

+3242256111

Other Identifiers

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UX007

Identifier Type: -

Identifier Source: org_study_id

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