Real-world Experience of Patients Newly Started on Erenumab in the Gulf Region: a Longitudinal Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 37
- 主要终点
- Mean score in the Treatment Satisfaction Questionnaire for Erenumab (TSQM) overall satisfaction scale score version 1.4
研究概览
简要总结
The objective of this study was to evaluate the effect of erenumab on medication-specific treatment satisfaction in patients who newly started on erenumab over 12 weeks
详细描述
This was a longitudinal prospective descriptive primary data collection using a 20 min online survey. Patients were selected by investigators (general neurologists, headache/migraine specialists) in primary care clinics and hospitals. After fulfilling the inclusion criteria, the patient were asked to sign an online informed consent. A 5 min screener followed after which the patient was directed through a link to the full survey. The duration of data collection was for 6 months since the start of survey rolling in each site across centers in the Gulf Region.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •EM& CM (with or without Medication Overuse Headache (MOH)) patients
- •Newly Started on erenumab either 70 mg or 140 mg (first dose received within 1 month prior study enrollment and baseline endpoints collection)
- •Ability to receive 3 monthly doses of erenumab.
- •Age more than 18 years
- •Males and Females
- •Allowing the patients to be stable on 1 adjunctive migraine preventive medication (if present)
- •Agreed to be included in the study and signed informed consent
排除标准
- •Less than 18 years
- •Age at onset of Migraine more than 50 years
- •Any contraindications to the start of erenumab as per label
- •Refusal to sign informed consent
- •Inability to participate or restricted access to the online survey
- •Enrolled in an interventional migraine-related study at the time of the study enrollement
结局指标
主要结局
Mean score in the Treatment Satisfaction Questionnaire for Erenumab (TSQM) overall satisfaction scale score version 1.4
时间窗: 12 weeks
TSQM is used to measure the Patients' self-reported satisfaction or dissatisfaction with the study treatment. The TSQM version 1.4 domain scores range from 0 to 100 with higher scores representing a higher satisfaction on that domain.
次要结局
- Mean score in TSQM version 1.4 effectiveness domain(Week 12)
- Mean change from baseline in the score of WPAI(Baseline, Week 12)
- Mean score in TSQM version 1.4 convenience domain(Week 12)
- Mean change from baseline in MHDs(Baseline, Week 12)
- Mean score in TSQM version 1.4 side effects domain(Week 12)
- Mean change from baseline in the score of HIT-6(Baseline, Week 12)
- Mean change from baseline in the score of MIDAS at week 12(Baseline, Week 12)
- Mean change from baseline in MMDs(Baseline, Week 12)
- Mean change from baseline in MSMDs(Baseline, Week 12)
- Mean change from baseline in the Patients' Global Impression of Change (PGIC) scale(Baseline, Week 12)