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 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT03193359
Eligibility Criteria:
Inclusion Criteria:
-Has successfully completed the double-blind study (1313-301-008).
Exclusion Criteria:
* Has met any of the withdrawal criteria in the double-blind study or has clinical significant abnormal laboratory or electrocardiogram (ECG) findings
* Headache attributable to another disorder (eg, cervical dystonia, craniotomy, head/neck trauma)
* Any medical condition that may put the patient at increased risk with exposure to Botulinum Toxin Type A, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03193359
Study Brief:
Protocol Section:
NCT03193359