E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027599 |
E.1.2 | Term | Migraine |
|
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 |
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 |
|
E.2.2 | Secondary objectives of the trial |
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 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
|
E.4 | Principal 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 with a low failure rate of less than 1% a year (e.g. oral contraceptive, some intra-uterine devices, 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. |
|
E.5 End points |
E.5.1 | 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) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.5.1 | Number of sites anticipated in the EEA | 31 |
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 | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |