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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT03666858
Eligibility Criteria:
Inclusion Criteria:
1. Confirmed diagnosis of episodic TTH, as determined by the International Classification of Headache Disorders.
2. Healthy participants who was prescribed 2 tablets of Neosaldina for episodic TTH.
3. Receive treatment according to the Summary of Product Characteristics for Neosaldina.
4. Has access to a mobile phone with the ability to download the app with the study questionnaire.
5. Has at least 1 episode of TTH per month.
Exclusion Criteria:
1. Currently participates or plans to participate in an interventional clinical trial.
2. Has hypersensitivity or intolerance to dypirone (or pyrazolonic derivatives) or other components of the product formula.
3. Has history of migraine, cluster headaches, chronic TTH or any other type of primary headache other than episodic TTH.
4. Has suspected secondary headache.
5. Has serious comorbidities (hypertension, blood dyscrasias, malignant neoplasms, any type of hepatitis or kidney disease, disorders of the hematopoietic system, insufficient function of the bone marrow or certain metabolic diseases, such as hepatic porphyria or congenital deficiency of glucose-6-phosphate dehydrogenase) or taking any medications which might confound the pharmacological effects of the study drug (example immunosuppressive drugs, and beta blockers, anticonvulsivants, antidepressants) within 30 days before the start of study.
6. Women who may be pregnant or breastfeeding during the course of the study.
7. Has history of alcohol abuse or other drugs according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
8. Has mental incapacity, unwillingness or language barriers unable to understand the guidelines specified in this protocol.
9. Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03666858
Study Brief:
Protocol Section:
NCT03666858