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
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Drug: Triheptanoin||Early Phase 1|
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)|
|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|
pilot-study with single arm of 10 migraine patients treated for 3 months with triheptanoin 1mg/kg/day
Triheptanoin oil administered three times per day during meals at a total dose 1mg/kg/day for 3 months
Other Name: UX007
- Change in monthly migraine days [ Time Frame: Between the 1-month baseline and the 3rd month of triheptanoin treatment ]
- Change in mean attack severity [ Time Frame: Between the 1-month baseline and the 3rd month of triheptanoin treatment ]
- Change in mean attack duration [ Time Frame: Between the 1-month baseline and the 3rd month of triheptanoin treatment ]
- 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 ]
- Tolerance and gastrointestinal adverse effects [ Time Frame: During the 3 months of triheptanoin treatment ]
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
|Contact: Jean Schoenen, MD, PhDfirstname.lastname@example.org|
|Contact: Delphine Magis, MD, PhDemail@example.com|
|Principal Investigator:||Jean Schoenen, MD,PhD||University Hospital Liège|