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Clinical Trial Summary

The purpose of this study is to describe pain relief in TTH with Neosaldina treatment.


Clinical Trial Description

This is an observational, non-interventional and prospective study of healthy participants with episodic TTH who have already been treated with Neosaldina according to regular clinical practice. This study will assess the pain intensity and pain relief of TTH after the uptake of Neosaldina. This study will enroll approximately 317 participants. All participants will be enrolled into one observational group: • Neosaldina Investigators will assess participants from the time of enrolment through the completion of observation period up to 6 months. Each participant will be assessed up to 45 days after first dose. The data will be collected from medical charts and during routine follow up visits. The data from participants will be collected through a self-administered questionnaire using a mobile phone. All the participants will be instructed to insert the data in an application, downloaded in their phone whenever they will have an episode of TTH and use Neosaldina. This multi-center trial will be conducted in Brazil. The overall duration of observation period in this study is approximately 6 months. Participants will be contacted by telephone on Days 15 and 30 for a follow up and will make a final visit on Day 45. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03666858
Study type Observational
Source Takeda
Contact
Status Completed
Phase
Start date December 20, 2018
Completion date August 19, 2019

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