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 @ 10:12 PM
Ignite Modification Date:
2025-12-24 @ 10:12 PM
NCT ID:
NCT01775735
Eligibility Criteria:
Key Inclusion Criteria:
* Onset of chronic migraine at least 6 months prior to start of Screening determined by a well-documented history
* Evidence of intractability
* Posterior-dominant head pain
* Stable pattern of headache symptoms for at least 6 months prior to the beginning of Screening
* Onset of migraine before the age of 50
* If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test
Key Exclusion Criteria:
* Diagnosed with any major psychiatric disorder not specifically listed in Key Exclusion Criteria 2-4 (e.g. multiple personality disorder, schizophrenia)
* Untreated panic disorder
* Untreated major depression evidenced by a PHQ-9 score \>20
* Untreated generalized anxiety disorder evidenced by a GAD-7 score ≥15
* Currently diagnosed with severe personality disorder
* A female of childbearing potential planning to get pregnant during the course of the study or not using adequate contraception
* Participating in another drug, device, or biologics trial within 3 months prior to Screening
* A terminal illness associated with survival \<24 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT01775735
Study Brief:
Protocol Section:
NCT01775735