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 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
NCT ID:
NCT07196657
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria;
* Aged over 18 years old;
* Suffering from moderate to severe FM, refractory to non-pharmacological interventions and without prior exposure to recommend pharmacological treatments for FM;
* Baseline numeric rating scale (NRS) score of 4 or higher;
* Aspartate aminotransferase and alanine aminotransferase levels below twice the upper limit of normal range;
* Estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m²;
* Willingness to provide informed consent and adequate cognitive and language capabilities to meet all study requirements;
Exclusion Criteria:
* Previous allergic reactions to pregabalin, crisugabalin, or any of their excipients;
* Prior diagnosis of epilepsy or depression requiring antidepressant therapy;
* Women who are pregnant or breastfeeding;
* Has severe systemic illnesses, such as poorly controlled hypertension, poorly controlled diabetes mellitus, or significant cardiac impairment;
* Suffering from acute or chronic pain disorders other than FM.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07196657
Study Brief:
Protocol Section:
NCT07196657