Migraine MedDRA version: 9.1 Level: LLT Classification code 10027599 Term: Migraine
Conditions
Sponsors
Addex Pharma SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient will be invited to participate if he/she meets the following inclusion criteria: 1. is willing and able to provide written informed consent 2. is male or female and aged 18 to 65 years, inclusive 3. has a history of migraine, with or without aura for at least 1 year according to the International Headache Society (IHS) diagnostic criteria 4. was aged = 50 years at onset of migraine history 5. has an historical migraine attack frequency of = 2 moderate/severe (IHS Grade 2/3) attacks per month in the previous 3-6 months 6. has = 3 moderate/severe (IHS Grade 2/3) migraine attacks or 5 migraine headache days in the 4 week baseline period, as confirmed from the eDiary data recorded on Days -28 to -1 inclusive 7. has an ability to communicate well with the study staff and to comply with the requirements of the entire study including compliance with eDiary completion 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: A patient will be excluded from study participation if he/she meets any of the following criteria: 1. suffers from cluster headaches or chronic migraine headaches 2. currently uses, or within 3 months of Screening, has used: a. sodium valproate or topiramate b. any other drugs used specifically for migraine prophylaxis, for example beta-blockers, calcium channel blockers, tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs) 3. has a total of > 10 headache days requiring treatment with a triptan or > 15 headache days, irrespective of whether any treatment is required (including nonsteroidal anti-inflammatory drug [NSAID] or other analgesics), in the baseline period, as confirmed from the eDiary data recorded on Days -28 to -1 inclusive 4. is unable to distinguish migraine headache from tension and other types of headache 5. has been non-responsive to > 1 other prophylactic migraine treatment 6. has a current history of psychiatric disorder requiring regular medication, for example SSRIs, selective noradrenaline reuptake inhibitors (SNRIs), TCAs and antipsychotic agents or, that in the opinion of the Investigator, could interfere with the conduct of the study 7. is an habitual user of recreational drugs (including amphetamine, methamphetamine, cocaine and opiates), or has a positive test for selected drugs of abuse at Screening 8. has a known history of alcohol abuse 9. has a known clinically significant allergy or known hypersensitivity to drugs that, in the opinion of the Investigator, may affect the patient’s safety 10. has clinically significant abnormal laboratory parameters at Screening, in particular, liver or renal functions tests greater than twice the upper limit of normal (ULN) or any other clinically significant biochemical or haematological abnormality as determined by the Investigator 11. has known or suspected human immunodeficiency virus (HIV) or hepatitis B or C 12. has a history of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study 13. is pregnant or breast-feeding. Female patients who are of child-bearing potential must be using adequate contraceptive methods (e.g. oral contraceptive, doublebarrier method, intra-uterine device, intra-muscular hormonal contraceptive), and have a negative pregnancy test at Screening and prior to randomisation on Day 1 14. has received any investigational drug within 30 days of Screening or any migraine prophylactic investigational drug within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of three different doses of ADX10059 compared with placebo when administered daily for 12 weeks to prevent migraine in patients with a history of moderate or severe migraine;Primary end point(s): Primary efficacy endpoint: The number of migraine headache days compared to baseline at weeks 9-12 of the treatment period will be evaluated. The baseline is defined as 28 to 30 days prior to randomisation (day -30 to -28);Secondary Objective: To evaluate the effects of three different doses of ADX10059 compared with placebo on: o frequency of migraine attacks o severity of migraine attacks o duration of migraine attacks o functional impairment o occurrence of aura o requirement for rescue medication o Headache Impact Test-6 (HIT-6) o patient Hospital Anxiety and Depression Scale (HADS) o patient and Investigator global assessment of study medication To evaluate the safety and tolerability in patients after repeated dosing with ADX10059 | — |
Countries
Austria, France, Germany, United Kingdom
Outcome results
None listed