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临床试验/CTRI/2024/11/076750
CTRI/2024/11/076750尚未招募不适用

Evaluating the Effectiveness and Safety of Nerivio Device in Chronic and Episodic Migraine A Retrospective Observational Real World Evidence Analysis

Dr Reddys Laboratories Ltd1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年11月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
试验地点
1
主要终点
Demographic information of the study population

研究概览

简要总结

This study is a retrospective, observational database study intended to analyze data collected from Aug 2023 to Jul 2024 from a medical patient support program conducted for Nerivio Device users. The REN device (Nerivio) is a wearable which provides pain relief from migraine. The study duration will be of 6 months. The objective of this study is to evaluate the data and understand effectiveness of Nerivio devise in Migraine management

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 95.00 Year(s)(—)
性别
All

入选标准

  • Adults diagnosed with migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria Patients who have been prescribed and have used REN devices within the past 12 months.

排除标准

  • Patients with incomplete medical records Patients with other significant chronic pain disorders Pregnant or breastfeeding women.

结局指标

主要结局

Demographic information of the study population

时间窗: baseline to end of 12 months

Categorize and assess the types of migraines duration of migraine history and patient profiles

时间窗: baseline to end of 12 months

Proportion of patients showing improvement in clinical signs and symptoms of migraine after using Nerivio

时间窗: baseline to end of 12 months

Reduction in migraine medication regimen

时间窗: baseline to end of 12 months

次要结局

  • Incidence of Adverse Event following the use of Nerivio(Baseline to 12 months)

研究者

申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Dr Mayank Dhore

Dr Reddys Laboratories limited

研究点 (1)

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