Background: Menstrually associated migraine (MAM) is often prolonged and difficult to manage with conventional therapies. Frovatriptan is a new selective 5HTlB/1D receptor agonist indicated for short term management o...Background: Menstrually associated migraine (MAM) is often prolonged and difficult to manage with conventional therapies. Frovatriptan is a new selective 5HTlB/1D receptor agonist indicated for short term management of migraine. It has a long half life and good tolerability. These characteristics suggest that frovatriptan may be useful for the intermittent prevention of MAM. Methods: The study was a randomized, double blind, placebo controlled, three way crossover design. Patients treated each of three perimenstrual periods (PMPs) with placebo, frovatriptan 2.5 mg QD, and frovatriptan 2.5 mg BID. The 6 day treatment started 2 days before the anticipated start of MAM headache. The primary efficacy endpoint was incidence of MAM headache during the 6 day PMP. Results: The population comprised 546 women (mean age, 37.6 years). Use of frovatriptan reduced the occurrence of MAM headache. The incidence of MAM headache during the 6 day PMP was 67% for placebo, 52% for frovatriptan 2.5 mg QD, and 41% for frovatriptan 2.5mg BID. Both frovatriptan regimenswere superior to placebo (p < 0.0001), and the BID regimen was superior to theQD regimen (p < 0.001). Both frovatriptan regimens also reduced MAM severity (p < 0.0001),duration (p < 0.0001),and the use of rescue medication (p < 0.01 QD; p < 0.0001 BID) in a dose dependent manner. The incidence and type of adverse events for both regimens were similar to placebo and consistent with those reported for short term migraine management. Conclusion: Frovatriptan given prophylactically for 6 days was effective in reducing the incidence of menstrually associated migraine. More than half of patients who used frovatriptan 2.5 mg BID had no menstrually associated migraine headache during the 6 day perimenstrual period. The findings are consistent with the long duration of action and good tolerability of frovatriptan observed in short term migraine management.展开更多
The purpose of this study was to test whether modafinil is effective in alleviating the symptoms of fatigue in postpolio patients, because it has been helpful for such symptoms in other neurologic disorders. Using a d...The purpose of this study was to test whether modafinil is effective in alleviating the symptoms of fatigue in postpolio patients, because it has been helpful for such symptoms in other neurologic disorders. Using a double-blind, randomized, placebo-controlled cross-over design, 14 postpolio patients with moderate to severe fatigue were assigned to receive modafinil or placebo first. Piper Fatigue Scale, Epworth Sleepiness Scale, digit span, and reaction time tests were done at baseline and then at weekly intervals. The Piper Fatigue Scale scores im proved by 27 ±40%(mean ±SD) following modafinil and by 43 ±36%following pla cebo. Scores for most of the other tests did not change during the study. Therefore, we conclude that modafinil was not effective in alleviating the symptoms of fatigue in postpolio patients.展开更多
一、"适应性设计"的概念及其含义适应性设计(adaptive design)是指在试验开始之后,在对试验的整体性与有效性不导致破坏的前提下,依据前期试验所得的部分结果调整后续试验方案,从而及时发现与更正试验设计之初一些不合理的假...一、"适应性设计"的概念及其含义适应性设计(adaptive design)是指在试验开始之后,在对试验的整体性与有效性不导致破坏的前提下,依据前期试验所得的部分结果调整后续试验方案,从而及时发现与更正试验设计之初一些不合理的假设,从而减少研究成本,缩短研究周期的一大类研究设计方法的总称[1-10].其中,研究方案中可进行调整的内容包括随机化分配方案、检验假设、样本量、劣效处理组的取舍、检验统计量以及结局变量等方面.因为其所具有的灵活性和可调整性,又被称为可变性设计(flexible design)、自适应设计(self-design)以及内部预试验设计(internal pilot design)等[11-16].所谓内部预试验主要是针对我们通常意义上所讲的外部预试验(external pilot design)而言,前者与研究主体(后继研究)连为一体,而后者则与研究主体完全分离.外部预试验适合于研究目的的改变,而内部预试验偏向于试验设计各项参数的调整,故与适应性设计意义相通.展开更多
文摘Background: Menstrually associated migraine (MAM) is often prolonged and difficult to manage with conventional therapies. Frovatriptan is a new selective 5HTlB/1D receptor agonist indicated for short term management of migraine. It has a long half life and good tolerability. These characteristics suggest that frovatriptan may be useful for the intermittent prevention of MAM. Methods: The study was a randomized, double blind, placebo controlled, three way crossover design. Patients treated each of three perimenstrual periods (PMPs) with placebo, frovatriptan 2.5 mg QD, and frovatriptan 2.5 mg BID. The 6 day treatment started 2 days before the anticipated start of MAM headache. The primary efficacy endpoint was incidence of MAM headache during the 6 day PMP. Results: The population comprised 546 women (mean age, 37.6 years). Use of frovatriptan reduced the occurrence of MAM headache. The incidence of MAM headache during the 6 day PMP was 67% for placebo, 52% for frovatriptan 2.5 mg QD, and 41% for frovatriptan 2.5mg BID. Both frovatriptan regimenswere superior to placebo (p < 0.0001), and the BID regimen was superior to theQD regimen (p < 0.001). Both frovatriptan regimens also reduced MAM severity (p < 0.0001),duration (p < 0.0001),and the use of rescue medication (p < 0.01 QD; p < 0.0001 BID) in a dose dependent manner. The incidence and type of adverse events for both regimens were similar to placebo and consistent with those reported for short term migraine management. Conclusion: Frovatriptan given prophylactically for 6 days was effective in reducing the incidence of menstrually associated migraine. More than half of patients who used frovatriptan 2.5 mg BID had no menstrually associated migraine headache during the 6 day perimenstrual period. The findings are consistent with the long duration of action and good tolerability of frovatriptan observed in short term migraine management.
文摘The purpose of this study was to test whether modafinil is effective in alleviating the symptoms of fatigue in postpolio patients, because it has been helpful for such symptoms in other neurologic disorders. Using a double-blind, randomized, placebo-controlled cross-over design, 14 postpolio patients with moderate to severe fatigue were assigned to receive modafinil or placebo first. Piper Fatigue Scale, Epworth Sleepiness Scale, digit span, and reaction time tests were done at baseline and then at weekly intervals. The Piper Fatigue Scale scores im proved by 27 ±40%(mean ±SD) following modafinil and by 43 ±36%following pla cebo. Scores for most of the other tests did not change during the study. Therefore, we conclude that modafinil was not effective in alleviating the symptoms of fatigue in postpolio patients.
文摘一、"适应性设计"的概念及其含义适应性设计(adaptive design)是指在试验开始之后,在对试验的整体性与有效性不导致破坏的前提下,依据前期试验所得的部分结果调整后续试验方案,从而及时发现与更正试验设计之初一些不合理的假设,从而减少研究成本,缩短研究周期的一大类研究设计方法的总称[1-10].其中,研究方案中可进行调整的内容包括随机化分配方案、检验假设、样本量、劣效处理组的取舍、检验统计量以及结局变量等方面.因为其所具有的灵活性和可调整性,又被称为可变性设计(flexible design)、自适应设计(self-design)以及内部预试验设计(internal pilot design)等[11-16].所谓内部预试验主要是针对我们通常意义上所讲的外部预试验(external pilot design)而言,前者与研究主体(后继研究)连为一体,而后者则与研究主体完全分离.外部预试验适合于研究目的的改变,而内部预试验偏向于试验设计各项参数的调整,故与适应性设计意义相通.
