Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT02160535
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of mild traumatic brain injury (mTBI) within the past 15 months
* Suffer at least fifteen total headache days per month
* Ability to speak and read English
Exclusion Criteria:
* Subject with hypersensitivity reactions or other intolerance to OnabotulinumtoxinA
* Previous use of OnabotulinumtoxinA for treatment of headache
* Any medications commonly used as headache preventives started less than 3 months prior to enrollment
* Prior or current diagnosis of major psychiatric disorder or other central nervous system disorder
* Less than 80% compliance (recorded for less than 24 days) in the 30 day screening headache diary
* Subjects who are pregnant or trying to become pregnant within the timeframe of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02160535
Study Brief:
Protocol Section:
NCT02160535