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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT07262268
Eligibility Criteria:
Key Inclusion Criteria:
1. Adult men and women between 18 to 75 years of age, inclusive, at time of consent with a diagnosis of inherited erythromelalgia with a previously characterized gain of function NaV1.7 mutation resulting in chronic pain.
2. Absence of concomitant mutation resulting in Kv7.2/7.3 gain of function.
3. Ability and willingness to adhere to the study procedures and complete accurate pain diaries
4. Stable background analgesic regimen for at least 30 days before screening and willingness to maintain the same analgesic regimen during the study period.
Key Exclusion Criteria:
1. Any clinically significant laboratory abnormalities or clinically significant abnormalities on screening physical examination, vital signs, or ECG that, in the judgment of the principal investigator, indicates a medical problem that would preclude study participation.
2. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07262268
Study Brief:
Protocol Section:
NCT07262268