Real World, Open Label Prospective Experience of Supplementation With a Fixed Combination of Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Change in monthly migraine days
研究概览
简要总结
To investigate efficacy and safety of a supplementation with a fixed combination of magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 (Vivinor®) in episodic migraine prevention, by an observational, prospective real-world study in 113 Greek patients with episodic migraine that were prospectively followed-up for three months. The primary endpoint was the change in monthly migraine days between baseline period (BL)and the third month of treatment (T3).
详细描述
To investigate efficacy and safety of a supplementation with a fixed combination of magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 (Vivinor®) in episodic migraine prevention.
An observational, prospective real-world study. After a one-month baseline period, Vivinor® was introduced in 113 Greek patients with episodic migraine that were prospectively followed-up for three months. The primary endpoint was the change in monthly migraine days between baseline period (BL)and the third month of treatment (T3). Secondary endpoints included changes in mean intensity of migraine and in days with use of acute migraine medications. Changes in scores of Migraine Disability Assessment questionnaire (MIDAS), Headache Impact Test-6 (HIT-6), Migraine Therapy Assessment questionnaire (MTAQ), MSQ-QOL (Migraine-Specific Quality of life questionnaire), HADS (Hospital Anxiety and Depression Scale) were also evaluated. Those with ≥50% reduction in monthly migraine days during T3 compared to BL were considered Vivinor®-responders.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •established diagnosis of episodic migraine with or without aura for more than one year prior to study entry
- •evidence of 4-14 migraine days per month during the last trimester prior to screening
- •participants may had been either treatment- naive or not suitable for or had failed previous migraine pharmacological prophylactic treatments
- •were able to fully understand protocol and study information provided by the investigators.
- •enrolled patients should take no other preventive treatment or use any other migraine prophylactic method during the three months before entering the study and throughout the study period.
排除标准
- •older than 50 years of age at migraine onset
- •evidence of MOH
- •pregnant or nursing females
- •history of tension-type, cluster or hemiplegic headache
- •history of severe anaphylactic reactions to any of the intervention's ingredients
- •evidence of severe systemic diseases
- •history or evidence of major psychiatric disorder.
结局指标
主要结局
Change in monthly migraine days
时间窗: 3 months
Change in monthly migraine days between baseline period (BL) and the third month of treatment (T3)
次要结局
- Mean intensity of migraine(3 months)
- days with use of acute migraine medications(3 months)
- Migraine Disability Assessment questionnaire (MIDAS)(3 months)
- Headache Impact Test-6 (HIT-6)(3 months)
- Migraine Therapy Assessment questionnaire (MTAQ)(3 months)
研究者
KONSTANTINOS SPINGOS
Dr.
Corfu Headache Clinic