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:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT01755702
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of episodic tension-type headache consistent with all of the following:
1. number of days with the condition is historically greater than or equal to two per month
2. onset of condition was greater than or equal to 12 months from Visit 1
3. age of onset was \< 50 years
4. severity of headaches is historically at least moderate
5. duration of headaches is historically greater than or equal to four hours, if untreated
6. number of headache episodes was greater than or equal to 4 and less than or equal to 10 during each of the three months immediately prior to Visit 1
7. treatment of headache episodes with OTC analgesics has historically provided pain relief in less than or equal to 2 hours
Exclusion Criteria:
* Subject has chronic tension type headache, which is defined as headache on more than 15 days per month for 3 months.
* If a migraine sufferer,subject averages more than one episode per month, is incapable of differentiating between tension-type headaches and migraine headaches, and/or requires regular or prophylactic use of migraine medications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01755702
Study Brief:
Protocol Section:
NCT01755702