EUCTR2008-005481-30-AT进行中（未招募）不适用
A phase 2B, randomised, double-blind, placebo-controlled, parallel group, dose-ranging, multicentre study to investigate the efficacy, safety and tolerability of the mGluR5 negative allosteric modulator ADX10059 for the prevention of migraine
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
- •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% per 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.
研究者
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