Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
NCT ID:
NCT04802967
Pre Assignment Details:
Separate randomization schemes were produced for each Part A (cross-over) of the study and Part B of the study. A simple randomization scheme was used for Part A, while a blocked randomization scheme was used for Part B.
Please note: Given the differences between Part A and Part B (design, objectives, endpoints, etc.) study results of the two parts cannot be merged.
Recruitment Details:
"Enrolled" is any subject who signed an ICF. "Randomized" are patients randomly assigned evenly between treatment sequences; "Dosed" is any subject who actually received at least one dose of IMP during the relevant Part.
In part A: n= 6 for all these definitions. In Part B: the enrolled and randomized were n=129; the dosed population is n=128 because 1 pt was randomized to the KLS 40 mg-GABA 17 mg but withdrawn prior to dosing due to a code break issue.
Study:
NCT04802967
Study Brief:
Results Section:
NCT04802967