A Randomized, Double-blind Placebo-controlled, Parallel Group Study to Study the Efficacy and Tolerability of Ramelteon (Rozerem) in the Prophylaxis of Migraine
概览
- 阶段
- 2 期
- 干预措施
- Ramelteon
- 疾病 / 适应症
- Migraine
- 发起方
- Swedish Medical Center
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- T-Test
- 状态
- 终止
- 最后更新
- 13年前
概览
简要总结
The purpose of this study is to see if ramelteon will reduce the number of migraine headaches over a 12 week period. The safety and tolerability of ramelteon will also be evaluated. Ramelteon has been approved by the U.S. Food and Drug Administration (FDA) for insomnia (trouble sleeping); however; ramelteon has not been approved for the prevention of migraines.
详细描述
Sleep has played an important role in migraine. Younger migraine sufferers usually report relief of migraine after sleep. In older migraine sufferers migraine is sometimes triggered with sleep changes. Occurrence of migraine in the early morning is very common. Therefore in these individuals regulation of sleep may improve the frequency of migraine. Recent PET studies done during migraine demonstrated activation of hypothalamus during migraine. In light of this new data and the known action of ramelteon on the melatonin receptors it may theoretically provide an insight on a possible mechanism of action in migraine.
研究者
入排标准
入选标准
- •Male or female, ages 18 to 65 years, inclusive.
- •An established history of migraine, with or without aura and probable migraine, conforming to the revised IHS criteria (2004) for at least 1 year before screening, sufficient to establish the diagnosis.
- •To be randomized, during the prospective 4-week baseline period (approximately 28 days before Visit 2), subjects must have more than 4 migraine/probable migraine attacks per month (using the 24-hour rule).
- •Must have been less than 50 years of age at the time of initial migraine onset.
- •Must have no clinically significant and relevant abnormalities on physical or neurologic examinations
- •Must have completed a washout of all prophylactic medications for migraine before the start of the 4-week prospective baseline period (ie, 28 days before Visit 2, when randomization occurs).
- •Female subjects must be at least 1 of the following:
- •postmenopausal, or
- •surgically incapable of being children, or
- •practicing a highly effective method of birth control
排除标准
- •Most frequent type of headache does not meet the revised IHS diagnostic criteria for migraine with aura or without aura or probable migraine.
- •Pregnant or lactating women, or sexually active women of childbearing potential who are not using an appropriate method of contraception.
- •Failed adequate trials of prophylactic agents with demonstrated or possible efficacy in the prophylaxis of migraine. These agents include beta-blockers, tricyclic antidepressants, valproate, topiramate, and methysergide.
- •Unable to complete the diary in a timely and accurate manner after each migraine headache attacks, either independently or with assistance.
- •Overuse of analgesics or specific agents for abortive treatment of migraine attacks, which makes the investigator suspect medication overuse headache.
- •Receiving non-pharmacological prophylactic treatments such as acupuncture, chiropractic, or massage, if these were started less than 1 month before the screening visit (Day -28). These therapies may be continued if started before that time.
- •Currently abusing alcohol or other drugs.
- •Have a central nervous system neoplasm or infection, demyelinating disease, degenerative or progressive central nervous system disease, or active epilepsy.
- •History of serious systemic disease, including hepatic insufficiency, renal insufficiency, a malignant neoplasm, any disorder in which prognosis for survival is less than 3 months, or any disorder which in the judgment of the investigator will place the subject at excessive risk by participation in a controlled trial.
- •Have a significant psychiatric disorder, such as acute psychosis, schizophrenia, severe bipolar disorder, or severe unipolar mood disorder, of sufficient severity to preclude safe and effective participation of the subject in the study.
研究组 & 干预措施
Active Treatment
Ramelteon once daily (double-blind assignment)
干预措施: Ramelteon
Placebo
Placebo tablet, once daily (double-blind assignment)
干预措施: Placebo
结局指标
主要结局
T-Test
时间窗: 4 weeks
It was planned to use a simple T-Test or ANoVa for data analysis. No Analysis was made due to insufficient recruitment. Planned primary efficacy variable was the percent reduction in the average monthly miqraine/probable migraine frequency from the baseline period to the entire double-blind treatment phase of the study.