Migraine with or without aura MedDRA version: 8.1 Level: PT Classification code 10027599
Conditions
Interventions
Product Name: ADX10059
Pharmaceutical Form: Capsule, hard
Current Sponsor code: ADX10059
Other descriptive name: (2-(3-Fluorophenylethynyl)-4,6-dimethyl-pyridin-3-yl)amine citrate
Concentration unit:
Sponsors
Addex Pharmaceuticals S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female and male patients aged 18 to 65 years. 2. Diagnosis of migraine with or without aura according to IHS criteria 1.1 and 1.2.1 3. Onset of migraine history prior to age 50 years 4. Patients who have between 2 and 8 moderate or severe migraine headaches per month. 5. Ability to communicate well with the study staff and to comply with the requirements of the entire study. 6. Patients who have provided written informed consent to participate in this study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Administration of any investigational drug up to 30 days before study entry or parallel participation in another study 2. Patients with more than 15 headache days per month. 3. Patients with known clinically significant allergy or known hypersensitivity to ADX10059 or lactose. 4. Patients who have abnormal laboratory parameters at screening, in particular, liver or renal functions tests greater than twice the upper limit of normal or any other clinically significant biochemical or hematological abnormality as determined by the investigator. 5. Patients with a history of a significant medical or psychiatric condition that may affect the safety of the patient or preclude adequate participation in the study. 6. Patients who are pregnant or breast-feeding. Female patients who are of child bearing potential must be using adequate contraceptive methods (e.g. oral contraceptives, intra uterine device (IUD), double barrier method (e.g. spermicide plus condom or diaphragm plus spermicide) and intra muscular hormonal contraceptive). 7. Patients using migraine prophylaxis must have been on stable doses of the prophylactic agent for least 12 weeks prior to study entry. 8. Patients taking sodium valproate or valproic acid or patients who have taken either of these within the last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary study objective is to evaluate the efficacy of oral ADX10059 in the acute treatment of moderate or severe migraine headache pain. ;Secondary Objective: As secondary parameters, the safety and tolerability of an oral administration of ADX10059 when taken by migraine patients and its efficacy in treating the accompanying non-headache symptoms of migraine will be evaluated.;Primary end point(s): Primary endpoint: ·Proportion of patients with initial moderate or severe (IHS Grade 2/3) pain who become pain free (IHS Grade 0) 2 hours after dosing. Secondary endpoints: ·Proportion of patients pain free (Grade 0 headache) 30 min., 1, 1.5, 3, 4 and 24 hours post dosing. ·Proportion of patients with Grade 1 or 0 headache (pain relief) 30 min., 1, 1.5, 2, 3, 4 and 24 hours post dosing. ·Actual (wristwatch) time to pain free (Grade 0 headache) following dosing. ·24-hour headache recurrence defined as the proportion of patients with Grade 0 headache at 2 hours post dose with a return to Grade 2/3 headache or Grade 1 headache that requires rescue medication in the subsequent 22 hours. ·Actual (wristwatch) time of headache recurrence. ·Sustained pain free response (patients with Grade 0 headache at 2 hours and no headache recurrence within 24 hours post dosing). ·Sustained headache response (patients with Grade 1/0 headache at 2 hours and no headache recurrence (Grade 2/3) within 24 hours post dosing. ·Severity of functional impairment 30 min., 1, 1.5, 2, 3, 4 and 24 hours post dosing. ·Presence of nausea, vomiting, photophobia and phonophobia at 30 min., 1, 1.5, 2, 3, 4 and 24 hours post dosing. ·Proportions of patients using rescue medication. ·Subjective evaluation of study medication by patient ·Time to meaningful relief of the overall migraine attack. ·Incidence and severity of adverse events. | — |
Countries
Germany, United Kingdom
Outcome results
None listed