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 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT04570293
Eligibility Criteria:
Inclusion Criteria:
* Occurrence of episodes of intense facial paroxysmal pain in the distribution(s) of one or more divisions of the trigeminal nerve, triggered by innocuous stimuli;
* Average daily pain intensity ≥ 4 by a brief pain inventory-short form (BPI-SF) Item 5 score (0-10 rating scale of average pain) in the preceding 24-hour period;
* Concomitant analgesic regimens that include 14 days of stable doses with systemic analgesics rather than topical agents for relief of PHN will be permitted
* Normal neurologic examination;
* Normal neuroimaging analysis.
Exclusion Criteria:
* Atypical pain location (eg, no specific trigger points) or trigger zones in the mouth;
* Proposed surgical intervention due to preference of the patient;
* Any condition known to interfere with the correct execution of the sensory tests (eg, peripheral or central neurological dysfunction or cognitive impairments);
* Presence of any other acute or chronic pain disorder with the need of systemic analgesic medication for more than 10 days in the last 3 months;
* Inability to discontinue the use of another lidocaine-containing products or a class I anti-arrhythmic drug during the study period;
* History of hypersensitivity to an amide-type local anesthetic agent, or other contents of the lidocaine or vehicle patch;
* History of surgical intervention or neurological ablation to treatment TN;
* Participation in another clinical trial within 30 days of the study;
* Any patient who was judged to be unreliable or unable to understand the protocol procedures;
* Any abnormality of the skin or of vascular origin at application site;
* Pregnancy or breastfeeding;.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04570293
Study Brief:
Protocol Section:
NCT04570293