EUCTR2007-002667-28-IT进行中（未招募）不适用
Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Multiple Attacks Studyto Compare the Efficacy and Safety of Oral MK-0974 With Placebo for the AcuteTreatment of Migraine With or Without Aura.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,800
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. Patient is ≥18 years of age at screening.
- •2. Patient has had a history of migraine with or without aura > 1 year with ≥ 1 and ≤ 8
- •moderate or severe migraine attacks per month in the 2 months prior to screening that
- •typically last between 4 to 72 hours untreated (see Appendix 6.1 and ICHD II
- •Attachment for IHS migraine definitions).
- •3. Patient is either:
- •a. of reproductive potential and agrees to maintain true abstinence* or use (or have
- •their partner use) one of the listed highly effective methods of birth control within
- •the projected duration of the study: hormonal contraceptives, intrauterine device
- •0974, Protocol 031-00 Issue Date: 10-Mar-2008 15
- •Product: MK-0974 7
- •Protocol/Amendment No.: 031-00
- •0974_031-00_ProtCore VERSION 6.0 APPROVED 10-Mar-2008
- •Worldwide Restricted Confidential Limited Access
- •(IUD), condoms, diaphragm, cervical cap, vasectomy. The use of barrier
- •contraceptive (condom, diaphragm, or cervical cap) should always be
- •supplemented with the use of a spermicide. Complete details regarding
- •contraceptive requirements are specified in protocol Section 3.2.3.2.
- •b. not of reproductive potential. The following definitions apply:
- •A female patient who is not of reproductive potential is defined as:
- •one who has either 1) reached natural menopause (defined as age 46 or older
- •with a) 12 months spontaneous amenorrhea or b) 6 months of spontaneous
- •amenorrhea with serum FSH levels in the postmenopausal range as
- •determined by the central laboratory), 2) 6 weeks post surgical bilateral
- •oophorectomy 3) hysterectomy, or 4) bilateral tubal ligation.
- •A male patient who is not of reproductive potential is defined as:
- •one who has undergone a successful vasectomy. A successful vasectomy is
- •defined as: 1) microscopic documentation of azoospermia, or 2) a vasectomy
- •more than 2 years ago with no resultant pregnancy despite sexual activity post
- •* If abstinence is not a locally acceptable method of contraception, then another highly
- •effective birth control method must be used.
- •4. Patient understands the study procedures, alternative treatments available, and risks
- •involved with the study, and voluntarily agrees to participate by giving written
- •informed consent.
- •5. Patient is able to complete the study questionnaire(s) and paper diary.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient is pregnant (positive serum pregnancy test at pre-study) or breast-feeding, or
- •is a female expecting to conceive within the projected duration of the study.
- •2. Patient has difficulty distinguishing his/her migraine attacks from tension headaches.
- •3. Patient has a history of predominantly mild migraine attacks or migraines that usually
- •resolve spontaneously in less than 2 hours.
- •4. Patient has basilar or hemiplegic migraine headache.
- •0974, Protocol 031-00 Issue Date: 10-Mar-2008 16
- •Product: MK-0974 8
- •Protocol/Amendment No.: 031-00
- •0974_031-00_ProtCore VERSION 6.0 APPROVED 10-Mar-2008
- •Worldwide Restricted Confidential Limited Access
- •5. Patient has more than 15 headache-days per month or has taken medication for acute
- •headache on more than 10 days per month in any of the 3 months prior to screening.
- •6. Patient is taking migraine prophylactic medication where the prescribed daily dose
- •has changed during the 3 months prior to screening.
- •7. Patient was > 50 years old at age of migraine onset.
- •8. Patient has clinical, laboratory, or ECG evidence of uncontrolled hypertension
- •(defined as SBP of ≥150 mm Hg and/or DBP of ≥95 mm Hg), uncontrolled diabetes,
- •HIV disease, or significant pulmonary,
研究者
相似试验
尚未招募
2 期
Monotherapy Phase II Dose Ranging Study of DAC HYP in Relapsing Remitting Multiple SclerosisMultiple SclerosisACTRN12606000306516Biogen Idec264
进行中（未招募）
不适用
Multicentre, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects with Relapsing-Remitting Multiple Sclerosis. - SELECTMultiple sclerosis (MS)MedDRA version: 8.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosisEUCTR2006-001161-42-HUBiogen Idec Ltd.600
进行中（未招募）
不适用
Effects of Neupro on cardiovascular observations in patients with restless legs syndromeEUCTR2011-000053-23-DECB Biosciences GmbH
进行中（未招募）
不适用
Multicenter, Double-Blind, Randomized, Placebo-Controlled, Three-Arm,Parallel Group Study to Evaluate the Efficacy and Safety of OxcarbazepineExtended-Release (OXC XR) (1200 and 2400mg/day) as AdjunctiveTherapy in Subjects with Refractory Partial Seizures due to Epilepsy on upto Three Concomitant Antiepileptic Medications - PROSPEREUCTR2008-003333-25-BGSupernus Pharmaceuticals, Inc.360
已完成
3 期
Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Ixekizumab in Patients from 6 to Less than 18 Years of Age with Moderate-to-Severe Plaque Psoriasis10014982Plaque PsoriasisNL-OMON45268Eli Lilly4