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Sumatriptan - ClinicalTrials.gov

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Last Updated: 02 March 2022

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Sumatriptan as Treatment for Moderate to Severe Post-Traumatic Headache

The primary aim of this Phase II open-label study is to determine the research methods and approaches that are most appropriate to carry out a Phase III study on post-traumatic headache management. We'll determine the reliability of using a headache diary with TBI-related illnesses in a sample of people with TBI and their caregivers as described during this research. Pre-treatment Visit : Subjects who complete informed consent and meet the inclusion criteria will be required to complete 30 days of headache diary to record their headache, migraine frequency, headache days, and migraine days as a result of their headache and related symptoms. With each patient, standard primary headache classification criteria will be tested to see if they meet criteria for migraine or suspected migraine. During the first month of the study to ensure compliance in diary use, research staff would call each participant weekly to check on compliance with drug diary use during the first month of the trial to check on compliance with diary use. If you're looking for a unique medication that they can use 2 hours after their second dose of study drug or 2 they've used their 30 day supply of study drugs within the month, a list of appropriate medications will be sent to them. When the participants start taking sumatriptan, we would get preliminary results on the safety of sumatriptan. The investigators will determine the percentage of headaches that had complete resolution pain free at 2 hours for each person during their first pre-intervention month when they used their regular therapy and afterwards when they treated headaches with sumatriptan and compare them using a paired t-test. By 30 minutes, no more than mild pain score =1 by 30 minutes, no more than mild pain score =1 by 30 minutes, no more than mild pain relief by 2 hours, no more than mild pain by 2 hours, no more than mild pain by 2 hours, no more than mild pain relief by 2 hours to see if another outcome measure may have advantages for a future Phase III research.

Source link: https://clinicaltrials.gov/ct2/show/NCT01854385

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions