EUCTR2005-004835-23-GB进行中（未招募）不适用
Multi-centre, parallel group, double-blind, placebo controlled study of the efficacy and tolerability of TONABERSAT in prophylaxis of migraine headache
Minster Pharmaceuticals Ltd0 个研究点目标入组 128 人开始时间: 2006年2月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 128
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
- •1.Male or female patients between 18 and 55 years of age. All women of childbearing potential who are not surgically sterilized must have a documented negative pregnancy test done at the screening visit and be practicing a medically acceptable contraceptive method for at least three months prior to enrolment with contraception maintained for at least seven days after the last dose of study medication. A reliable form of contraception is defined as follows: oral birth control pills taken for at least three cycles prior to entering the study and continued throughout the study; an intra uterine device inserted by a qualified clinician; medroxyprogesterone acetate (Depo provera) active for at least three months prior to entering the study and with continued administration at intervals sufficient to maintain contraceptive efficacy throughout the study period; sterilization (via hysterectomy or bilateral tubal ligation); and sterilization of partner. Women of childbearing age must have no intention of becoming pregnant during the study period.2.Patients should have an established history of migraine of at least one year with or without aura, meeting the diagnostic criteria of the International Classification of Headache Disorders – Edition 2 (Appendix 3) and experience between four and 14 migraine headache days per month; headache days should be experienced within at least two and no more than six migraine attacks per month.
- •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
- •1.Patients with a diagnosis of migraine according to the diagnostic criteria of the International Classification of Headache Disorders – Edition 2 (Appendix 3) at age 50 years or more.
- •2.Experience headache other than migraine more than once a month.3.Patients with pure menstrual migraine defined as patients in whom migraine attacks occur exclusively on Day 1 +/- 2 (i.e. Days -2 to +3) of menstruation in at least two out of three menstrual cycles and at no other times of the cycle.
- •4.Patients with other significant central nervous system disorders in the opinion of the investigator.
- •5.Failure to respond to no more than two adequately dosed (i.e. recommended total daily dose and of sufficient duration) migraine prophylactic medications.
- •6.Overuse of acute migraine treatments defined as more than 14 medication days per month with analgesics and opioids and nine medication days per month of ergots or triptans.
- •7.Prophylactic treatment within two months prior to entry to the trial.
- •8.Patients taking any of the following medications: beta-blockers (during the last two months), tricyclic antidepressants (during the last two months), antiepileptic drugs (during the last two months), calcium channel blockers (during the last two months), monoamine oxidase inhibitors (during the last two months), daily oral NSAIDs, daily paracetamol, high dose magnesium supplements (600 mg/day), daily multivitamin preparations containing more than 10 mg riboflavin, daily use of oral corticosteroids and daily herbal preparations (e.g. feverfew, butterwort and St John’s Wort). Parenteral administration of Botulinum toxin is also excluded. Patients taking other medications used as prophylaxis for migraine including methysergide, anti spasticity agents (e.g. tizanadine) and the new generation antipsychotics (e.g. olanzapine) currently or within the previous 2 months should also be excluded.
- •9.Patients who, in the opinion of the investigator, have significant cerebrovascular disease, e.g. transient ischaemic attacks, stroke.
- •10.Patients who, in the opinion of the investigator, have clinically significant cardiovascular disease.
- •11.Patients suffering from a current clinical diagnosis of major depressive disorder or schizophrenia.
- •12.Patients with renal dysfunction, defined as a serum creatinine of greater than 125% of the upper limit of normal for their age group.
- •13.Patients with hepatic dysfunction defined as a liver function test (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, bilirubin) of greater than twice the upper limit of normal for their age group.
- •14.Patients with known alcohol or other substance abuse.
- •15.Failure to complete the diary card during the screening period.
- •16.Participation in another clinical trial in the previous four weeks.
- •17.Any woman who is pregnant, lactating or not using medically acceptable contraception.
研究者
相似试验
进行中（未招募）
不适用
Multi-centre, parallel group, double-blind, placebo controlled study of the efficacy and tolerability of TONABERSAT in prophylaxis of migraine headacheMigraine with or without aura meeting the diagnostic criteria of the International Classification of Headache Disorders (Edition 2).EUCTR2005-004835-23-DKMinster Pharmaceuticals Ltd128
进行中（未招募）
不适用
Multi-centre, parallel group, double-blind, placebo controlled study of the efficacy and tolerability of TONABERSAT in prophylaxis of migraine headacheMigraine with or without aura meeting the diagnostic criteria of the International Classification of Headache Disorders (Edition 2).EUCTR2005-004835-23-HUMinster Pharmaceuticals Ltd128
已完成
3 期
Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson's disease patients with motor complications not well controlled on medical treatment.Parkinson's diseaseparkinsonismNL-OMON41299Britannia Pharmaceuticals Ltd20
未知
2 期
Multi-Center, Parallel-Group, Double-Blind, Placebo-Controlled, Dose Ranging Study of the Safety and Efficacy of Oral Lubiprostone in Patients with Chronic Idiopathic ConstipatioChronic Idiopathic ConstipationJPRN-jRCT2080220460Sucampo Pharma, Ltd.
进行中（未招募）
1 期
Pilot Study to investigate Safety and Efficacy of 8 weeks Treatment of Actinic Keratosis with DFD-07 CreamActinic Keratosis (AK)EUCTR2015-003804-21-DEPromius Pharma LLC