MigraineEarly Phase 1TRIMINCT02784847
A Pilot Trial of Triheptanoin for the Preventive Treatment of Migraine
A Early Phase 1 study testing Triheptanoin in people with Migraine, run by University of Liege.
Trial summary
A pilot trial of triheptanoin, a natural compound able to promote anaplerotic mitochondrial metabolism, for the preventative treatment of migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Migraine
- What is being tested?
- Triheptanoin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Nov 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- > 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 locations and contacts
No sites are listed yet.
About this study
A pilot trial of triheptanoin, a natural compound able to promote anaplerotic mitochondrial metabolism, for the preventative treatment of migraine.
Read the 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.
- Conditions
- Migraine
- Being tested
- Triheptanoin
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriheptanoinDrug
Also called UX007
Triheptanoin oil administered three times per day during meals at a total dose 1mg/kg/day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Other | pilot-study with single arm of 10 migraine patients treated for 3 months with triheptanoin 1mg/kg/day Receives: Drug: Triheptanoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in monthly migraine days
Measured: Between the 1-month baseline and the 3rd month of triheptanoin treatment
Secondary outcomes (3)
Change in mean attack severity
Measured: Between the 1-month baseline and the 3rd month of triheptanoin treatment
Change in mean attack duration
Measured: 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
Measured: Between the 1-month baseline and the 3rd month of triheptanoin treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startJun 2016
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Schoenen, University of Liege
- Investigators
- Jean Schoenen, MD,PhD, Principal investigator, University Hospital Liège
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784847
- Sponsor's protocol ID
- UX007
- Acronym
- TRIMI
- Status last verified
- May 2016
- First submitted
- 10 Mar 2016
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Triheptanoin for the Preventive Treatment of Migraine
- ClinicalTrials.gov ID
- NCT02784847
- Acronym / sponsor ID
- TRIMI / UX007
- Conditions
- Migraine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot trial of triheptanoin, a natural compound able to promote anaplerotic mitochondrial metabolism, for the preventative treatment of migraine.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Other | Drug: Triheptanoinpilot-study with single arm of 10 migraine patients treated for 3 months with triheptanoin 1mg/kg/day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- > 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TriheptanoinAlso: UX007Triheptanoin oil administered three times per day during meals at a total dose 1mg/kg/day for 3 months | Drug | treatment arm |
Primary outcome
Change in monthly migraine days
Time frame: Between the 1-month baseline and the 3rd month of triheptanoin treatment
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Schoenen, MD,PhD principal investigator
University Hospital Liège
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Triheptanoin in people with Migraine, run by University of Liege.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean Schoenen, MD, PhD (+3242238663, jschoenen@ulg.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in monthly migraine days (time frame: Between the 1-month baseline and the 3rd month of triheptanoin treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2016.