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

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ClinicalTrials.gov Identifier: NCT02784847
Recruitment Status : Unknown
Verified May 2016 by Jean Schoenen, University Hospital of Liege.
Recruitment status was:  Not yet recruiting
First Posted : May 27, 2016
Last Update Posted : May 27, 2016
Sponsor:
Information provided by (Responsible Party):
Jean Schoenen, University Hospital of Liege

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

Condition or disease Intervention/treatment Phase
Migraine Drug: Triheptanoin Early Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Trial of Triheptanoin for the Preventive Treatment of Migraine
Study Start Date : June 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
treatment arm
pilot-study with single arm of 10 migraine patients treated for 3 months with triheptanoin 1mg/kg/day
Drug: Triheptanoin
Triheptanoin oil administered three times per day during meals at a total dose 1mg/kg/day for 3 months
Other Name: UX007




Primary Outcome Measures :
  1. Change in monthly migraine days [ Time Frame: Between the 1-month baseline and the 3rd month of triheptanoin treatment ]

Secondary Outcome Measures :
  1. Change in mean attack severity [ Time Frame: Between the 1-month baseline and the 3rd month of triheptanoin treatment ]
  2. Change in mean attack duration [ Time Frame: Between the 1-month baseline and the 3rd month of triheptanoin treatment ]
  3. 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 Outcome Measures:
  1. Tolerance and gastrointestinal adverse effects [ Time Frame: During the 3 months of triheptanoin treatment ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02784847


Contacts
Contact: Jean Schoenen, MD, PhD +3242238663 jschoenen@ulg.ac.be
Contact: Delphine Magis, MD, PhD +3242256111 dmagis@chu.ulg.ac.be

Sponsors and Collaborators
University Hospital of Liege
Investigators
Principal Investigator: Jean Schoenen, MD,PhD University Hospital Liège

Responsible Party: Jean Schoenen, Honorary Professor, University Hospital of Liege
ClinicalTrials.gov Identifier: NCT02784847     History of Changes
Other Study ID Numbers: UX007
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: May 27, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases