Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-25 @ 1:59 PM
NCT ID:
NCT05184192
Group ID:
EG001
Title:
Placebo
Description:
Placebo gelatin capsules that look, smell, and taste like gabapentin capsules will be given to the placebo arm.
To preserve double-blinding of the study, subjects will receive one capsule TID the first week, the second week two capsules TID, the third week three capsules TID, and fourth week four capsules TID as tolerated. If intolerable, the dose will be decreased to prior tolerable dose.
The next eight weeks will be a fixed amount of placebo based on the highest tolerable amount from the titration period.
Subjects will then taper-down placebo to imitate the gabapentin arm for maximum two weeks based on highest dose achieved during study.
4 weeks after completion of taper-down, follow-up assessments will be conducted.
Placebo: lactose monohydrate NF
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
26
Other Number Affected:
11
Other Number At Risk:
26
Study:
NCT05184192
Results Section:
NCT05184192
Adverse Events Module:
NCT05184192