Pilot Study for the Evaluation of the Efficacy of OnabotulinumtoxinA in High Frequency Migraine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Migraine days/month
研究概览
简要总结
Population studies estimate that patients who have episodic migraine transition to chronic migraine at a rate of about 2.5% per year.
CM is a devastating disorder associated to severe disability. Patients with CM frequently overuse symptomatic medications in the attempt to control their disease, which adds up to the high costs associated to the disorder In this frame, it seems of the outmost importance to strive at preventing the transition from EM to CM.
At the moment Onabotulinum toxin A (BoNT-A) represents the only drug specifically approved for CM prophylaxis.
The aim of the present study was to evaluate the efficacy of BoNT-A in reducing the number of migraine days in a population of migraineurs with a high frequency of migraine attacks over a 12-month period.
详细描述
Episodic migraine (EM) is a common type of disabling headache that affects up to 15% of the general population. In a minority of patients, migraine progressively increase in frequency, until it becomes chronic. According to the criteria of the International Headache Society chronic migraine (CM) is characterized by a headache that is present on at least 15 days per month over at least three months period, with migraine characteristics on at least 8 days/month. Population studies estimate that patients who have episodic migraine transition to chronic migraine at a rate of about 2.5% per year.
CM is a devastating disorder associated to severe disability. Patients with CM frequently overuse symptomatic medications in the attempt to control their disease, which adds up to the high costs associated to the disorder In this frame, it seems of the outmost importance to strive at preventing the transition from EM to CM.
Transition to CM rarely is a rapid phenomenon. Most often it occurs over several months or years during which the frequency of attacks progressively increases as does the intake of acute medications. High monthly headache frequency is a risk factor for the progression of episodic migraine to chronic migraine. Compelling evidence from clinical and pre-clinical studies suggests that the transformation into CM is associated to, and probably brought about by, plastic changes in the peripheral and central nervous system induced by the repetitive occurrence of pain attacks. These changes configure a condition of chronic sensitization, usually associated to a reduced response to treatments.
In this frame, it is noteworthy that the investigators previously showed that patients with CM overusing acute medications bear a condition of enhanced facilitation of spinal cord pain processing that is detectable with specific neurophysiological evaluations. The situation normalizes, i.e. pain facilitation is reduced, 60 days after successful treatment. Similarly, the Danish group showed that patients with chronic headache associated to medication overuse (most of whom were suffering from CM) are sensitized to pain, and pain perception continues to normalise over a period of at least 12 months when patients are successfully treated.
At the moment Onabotulinum toxin A (BoNT-A) represents the only drug specifically approved for CM prophylaxis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects fulfilling the diagnostic criteria for migraine without or with aura of the International Headache Classification with a number of migraine days ranging from 9 to 14 days/month in the previous 3 months.
- •The frequency needs to be confirmed over the 28 days before the screening visit .
- •Subjects have to be in general good health, as confirmed by medical history, baseline physical examination, baseline neurological exam and vital signs.
- •Females have to be postmenopausal for at least one year, surgically sterile or otherwise incapable of pregnancy, or using an acceptable method of birth control.
排除标准
- •Previous failure of more than two adequate trials of medications from different drug classes used for migraine prophylaxis;
- •Onset of migraine after age 50;
- •Exclusively migraine aura without headache;
- •Diagnosis of other primary or secondary headache disorders. Episodic tension-tyep headache is allowed if the patient can distinguish clearly between attack of migraine and of tension-type headache;
- •Another chronic painful condition (e.g. osteoarthritis, low back pain);
- •A significant medical history or medical condition of neurological, cardiovascular hepatic or renal disease;
- •History of suicide attempt or suicidal ideation or of a major psychiatric disorder;
- •History of drug or alcohol abuse within the past two years.
- •Known hypersensitivity to botulinum toxin type A or to any of the other ingredients used to form 'Botox®'
- •Withdrawal criteria
- •Severe side effects, diary completion insufficient for evaluation.
研究组 & 干预措施
BOTOX
155 UI of Botox were injected according to the approved PREEMPT protocol (the only FDA-approved injection pattern for chronic migraine), in 31 sites. From visit 5, the PREEMPT 'follow-the-pain' paradigm was applied in patients falling in the 'non-responder' or 'partial responder' classes after the first BoNT-A injection, with the possibility to increase the doses up to 195 UI in maximum 39 sites. The injections were every 3 months for 4 cycles
干预措施: OnabotulinumtoxinA (Drug)
结局指标
主要结局
Migraine days/month
时间窗: In the last 16 weeks of the study period as compared to the 4 baseline weeks.
To evaluate the efficacy of BoNT-A in reducing the number of migraine days in a population of migraineurs with a high frequency of migraine attacks over a 12-month period. Based on the response in terms of percent reduction of migraine days from baseline, the following classes will be identified: * non-responders: reduction \< 30%; * partial responders: reduction ranging from 30 to 49%; * responders: reduction ranging from 50% to 74%; * optimal responders: reduction \>75%.
次要结局
- Monthly headache days(In the last 16 weeks of the study period as compared to the 4 baseline weeks.)
- Mental Status Questionnaire (MSQ)(In the last 16 weeks of the study period as compared to the 4 baseline weeks.)
- Hospital Anxiety and Depression Scale (HADS)(In the last 16 weeks of the study period as compared to the 4 baseline weeks.)
- Migraine attack intensity(In the last 16 weeks of the study period as compared to the 4 baseline weeks.)
- Monthly use of acute drugs(In the last 16 weeks of the study period as compared to the 4 baseline weeks.)
- Migraine Disability Assessment Score Questionnaire (MIDAS)(In the last 16 weeks of the study period as compared to the 4 baseline weeks.)