Randomized, double-blind, placebo-controlled study to compare the efficacy of riboflavin versus propranolol in prophylaxis of migraineAcronym: RiMiPro
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Percentage of patients who achieved 50% or greater decrease in the number of migraine attacks during the 3rd month, compared to the run-in month.
研究概览
简要总结
This study was a randomized, double-blind, placebo-controlled parallel group, single-center trial to compare the efficacy and safety of Riboflavin 20 mg b.d. with Propranolol 40 mg b.d. for 3 months in prophylaxis of migraine. The trial had three arms: 1) Riboflavin 20 mg b.d. for 3 months; 2) Propranolol 40 mg b.d. for 3 months; and 3) Placebo b.d. for 3 months. The primary outcome measure was the percentage of patients who achieved 50% or greater decrease in the number of migraine attacks during the 3rd month, compared to the run-in month. The trial has completed, however, the results have not been submitted/published anywhere.
研究设计
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
入选标准
- •1.Patient of either sex between age group18-65 years who have not received any drug for migraine prophylaxis before.2.Medical history consistent with migraine with or without aura according to the International Headache Society (IHS) for at least 1 year prior to the study.3.More than four migraine episodes per month but no greater than 15 headache days (migraine and non-migraine) in one month during the baseline phase.
- •There should be a gap of at least 48 hours between two episodes.
- •Frequency of non-migraine headaches should be no more than 6 episodes per month.4.No significant abnormalities on clinical examination at baseline.5.Female patients must be either postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception during the complete study period.6.Willing to provide informed consent.7.Patients able to maintain a headache diary.
排除标准
- •1.Patients with headaches other than migraine who cannot differentiate migraine from other headaches.2.Onset of migraine after age of 50 years 3.Patients who have taken antipsychotics or antidepressants during the previous 3 months.4.Patients who abuse alcohol or other drugs.5.Patients who use drugs excessively for headache (more than 10 days per month).6.Pregnant or lactating women7.Patients with heart or kidney diseases, asthma or diabetes or otherwise unhealthy.
结局指标
主要结局
Percentage of patients who achieved 50% or greater decrease in the number of migraine attacks during the 3rd month, compared to the run-in month.
时间窗: 3 months
次要结局
- ?Percentage of patients who achieved 50% or greater decrease in the number of migraine days during the 3rd month, compared to the run-in month.?Difference between the two groups in the third month regarding the use of rescue medications and regarding the adverse effects.(3 months)