E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
Frequent attacks of migraine |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluate in a pilot trial the possible therapeutic effect of triheptanoin on frequency of migraine attacks |
|
E.2.2 | Secondary objectives of the trial |
Evaluate the tolerance of tripheptanoin in migraine patients |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Females aged 18-65 years old having an effective contraception, having undergone a bilateral salpingo-oophorectomy or being menopaused, willing and able to fill in the headache diary and to recognize their migraine attacks
- 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
|
|
E.4 | Principal exclusion criteria |
- > 4 tension-type headache episodes per month (ICHD-3beta 2.2 & 2.3)
- Medication overuse headache or other headache types (ICHD-3beta 8.2)
- Resistance to >3 previous preventive anti-migraine drug treatments
- Any serious medical or psychiatric condition
- Having a concurrent disease or condition, or laboratory abnormality that, in the view of the Investigator, places the subject at high risk of poor treatment compliance or of not completing the study, or would interfere with study participation or introduces additional safety concerns
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measures will be in concordance with international guidelines (Tfelt-Hansen et al. 2012):
- change in monthly migraine days 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 between the 1-month baseline and the 3rd month of triheptanoin treatment
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
after 3 months of treatment |
|
E.5.2 | Secondary end point(s) |
Change in:
- monthly migraine days between the 1-month baseline and the average monthly migraine days during the 3 months of triheptanoin treatment
- monthly migraine attacks between the 1-month baseline and the 3rd month of triheptanoin treatment
- ean attack severity between the 1-month baseline and the 3rd month of triheptanoin treatment
- mean attack duration between the 1-month baseline and the 3rd month of triheptanoin treatment
- number of migraine days associated with nausea/vomiting between the 1-month baseline and the 3rd month of triheptanoin treatment
- number of migraine days associated with photo-/phonophobia between the 1-month baseline and the 3rd month of triheptanoin treatment
- monthly intake of acute anti-migraine drugs between the 1-month baseline and the 3rd month of triheptanoin treatment
and
- patients’ satisfaction assessed by 2 questions |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
after 3 months of treatment |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
after 3 months of treatment at the last visit of the last patient participating in the trial |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |