Delving into the Latest Updates on Minster Research Ltd with Synapse

Multi-Centre, Parallel Group, Double-Blind, Placebo Controlled, Dose Ranging Study of the Efficacy and Tolerability of Tonabersat in the Prophylaxis of Migraine Headache and Open Label Extension

Primary objective:
To investigate the efficacy and tolerability of two doses of tonabersat compared to placebo in the prophylaxis of migraine headache and to evaluate the longer term tolerability of tonabersat in an open label extension.
Secondary objective(s):
To obtain further data on the efficacy and dose response of tonabersat; To extend the safety and tolerability database of tonabersat; To obtain data on the pharmacokinetics of tonabersat.

开始日期2007-10-01

申办/合作机构

Minster Research Ltd

NCT00332007 / Completed临床2期

A Single Centre, Double-blind, Randomised, Placebo Controlled Crossover Study to Evaluate the Efficacy and Tolerability of Tonabersat in the Prophylaxis of Migraine in Patients Presenting With Migraine With Aura

Overall trial objectives:
Can treatment with tonabersat reduce the number of days with aura and/or migraine headache in patients with migraine with aura
How well tolerated is treatment with tonabersat
The study is based on the hypothesis that the unique mechanism of action of tonabersat will inhibit some of the early events in the generation of aura and migraine headache and so be effective as prophylactic treatment

开始日期2006-05-01

申办/合作机构

Minster Research Ltd

[+1]

NCT00311662 / Completed临床2期

Multi-centre, Parallel Group, Double-blind, Placebo Controlled Study of the Efficacy and Tolerability of Tonabersat in the Prophylaxis of Migraine Headache

Overall trial objectives:
Can treatment with tonabersat reduce the number of days with a migraine headache in patients who suffer from frequent migraine attacks
How well tolerated is treatment with tonabersat
The study is based on the hypothesis that the unique mechanism of action of tonabersat will inhibit some of the early events in the generation of migraine and so be effective as prophylactic treatment

开始日期2006-04-01

申办/合作机构

Minster Research Ltd

100 项与 Minster Research Ltd 相关的临床结果

登录后查看更多信息

0 项与 Minster Research Ltd 相关的专利（医药）

登录后查看更多信息

1

项与 Minster Research Ltd 相关的文献（医药）

2009-07-01·Cephalalgia2区 · 医学

Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study of the Cortical Spreading Depression Inhibiting Agent Tonabersat in Migraine Prophylaxis

2区 · 医学

Article

作者: Goadsby, PJ ; Ferrari, MD ; Csanyi, A ; Olesen, J ; Mills, JG

Tonabersat is a novel putative migraine prophylactic agent with an unique stereospecific binding site in the brain. Tonabersat has been shown, in animal models, to inhibit experimentally induced cortical spreading depression, the likely underlying mechanism for migraine aura, and cerebrovascular responses to trigeminal nerve stimulation. The aim was to study the potential for tonabersat as a migraine preventive. A randomized, double-blind, placebo-controlled, multicentre, parallel group study recruited patients with migraine with and without aura experiencing between two and six migraine attacks per month. After a 1-month baseline they received tonabersat 20 mg daily for 2 weeks and 40 mg daily for a further 10 weeks. The primary end-point was the change in mean number of migraine headache days between the third month and the baseline period in the intention-to-treat population comparing the placebo ( n = 65) and tonabersat ( n = 58) groups. At the primary end-point there was a 1.0-day (95% confidence interval −0.33, 2.39; P = 0.14) difference in reduction in migraine days between tonabersat and placebo. There were 10 secondary efficacy end-points, of which two were statistically significant. In month 3 of treatment, the responder rate, defined as a 50% reduction in migraine attacks, was 62% for tonabersat and 45% for placebo ( P < 0.05), and the rescue medication use was reduced in the tonabersat group compared with placebo by 1.8 days ( P = 0.02). Placebo responses were particularly high for all end-points. At least one treatment-emergent adverse event was reported in the tonabersat group in 61% of patients compared with 51% in the placebo group; none was worrisome. Placebo responses were unexpectedly high in this trial, complicating straightforward interpretation of the study results. The good tolerability and promising efficacy results support further exploration of higher doses of tonabersat in larger controlled trials.

100 项与 Minster Research Ltd 相关的药物交易

登录后查看更多信息

100 项与 Minster Research Ltd 相关的转化医学

登录后查看更多信息