A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging, Multicenter Study of the Efficacy of RWJ-333369 in the Prophylaxis of Migraine - Efficacy study of 333369 for the Prophylaxis of Migraine

Janssen Cilag International NV0 个研究点目标入组 300 人开始时间: 2005年9月29日最近更新: 2012年3月19日

试验速览

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•Male or female, ages 18-65.
•Meet revised IHS criteria (2003) for migraine with or without aura, or both types for at least 1 year before screening. In addition, should have a retrospective 3-month history of approximately 3 to 12 migraine attacks per month (defined using the 48-hour rule).
•During the prospective 4-week baseline period, must have between 3 and 12 migraine attacks per month, and no more than 15 headache days per month.
•Must have been less than 50 years of age at time of initial migraine onset.
•Must have completed a washout of all prophylactic medications for migraine before the start of the 4-week prospective baseline period.
•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

•Most frequent type of headache is nonmigrainous, or subjects with mixed headaches who are unable to distinguish migraines from other headache types.
•Failed adequate trials of 3 or more prophylactic agents for the prophylaxis of migraine.
•Unable to complete the headache diary in a timely and accurate manner after each migraine attack.
•Overuse analgesics or specific agents for abortive treatment of migraine attacks.
•Receiving nonpharmacological prophylactic treatments, such as acupuncture, if these were started less than 1 month prior to screening visit.
•Currently abusing drugs or alcohol.
•Have a CNS neoplasm or infection, demyelinating disease, degenerative or progressive CNS disease, or active epilepsy.
•History of serious systemic disease, including hepatic or renal insufficiency, uncontrolled congestive heart failure, malignant neoplasm, clinical or ECG evidence of significant cardiac disease, or any disorder where prognosis for survival is less than 3 months.
•Significant psychiatric disorders, such as acute psychosis, schizophrenia, bipolar disorder, or major depressive disorder.
•Require continued use of medications disallowed by the protocol (see protocol).
•Any history of suicide attempt or ideation.

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