Table 1 Part II patient visit content
From: SipNose-topiramate: a potential novel approach to binge eating management
Visit # and time | Content |
|---|---|
Visit 1 time = 0 | Screening Signing consent form (ICF) Confirming eligibility for study participation Detailed review of past medical history Structured Clinical Interview (SCID) [41] Eating Disorder Examination (EDE) [42] Review of concomitant medications and general health status in the week preceding the visit Demographics, including height Weight measurement Complete physical examination, including nasal mucosa examination Drawing safety screening laboratory blood and urine samples Urine pregnancy test for women t0 baseline: Clinician Global Impression (CGI-S) [52] and Yale-Brown Obsessive Compulsive Binge Eating Scale (Y-BOCS-BE) [44, 52] |
Diaries Training on diary documentation during the baseline period Electronic diary system (e-Diary) training, including the two diary forms (Diary #1 and Diary #2) patients were requested to fill during the study Receiving e-Diary IFU, a user name and password Patients were requested to complete the diaries during the subsequent two weeks, aimed to characterize their binge-eating behavior (Diary #1) | |
Visit 2 BP 2nd week Time = 2 week | Baseline period–assessment t2 - CGI-S t2 - Y-BOCS-BE Number of binge-eating days per week Number of binge-eating events per week |
Decision to include/exclude. Criteria to continue including the patient in the study Completed diaries (visit 2—have to show at least 2 binge-eating days per week) Laboratory baseline that shows no deviation from required value | |
Guide for included patients Receiving treatment kits to cover the maximum allowed treatments per one week which are sufficient for use prior to the next visit Receiving a quick reminder of how the product shall be used, and how to fill the diaries | |
Visit 3: TP 1st week Time = 3 week | Treatment period—assessment 1 Review of possible adverse events Return the devices from the 1st treatment week Review the e-diaries of the 1st treatment week and receive inputs which could potentially improve completion of the e-diaries and data collection t3 - CGI-S and Y-BOCS-BE scores Receive devices for the next two (2) treatment weeks |
Visit 4: TP 2nd week Time = 4 week | Review of possible adverse events Review e-Diaries with the study staff and receive inputs t4 - CGI-S and Y-BOCS-BE scores |
Visit 5: TP 3rd week Time = 5 week | Review of possible adverse events t5 - CGI-S and Y-BOCS-BE scores Return the devices of the preceding two (2) treatment weeks Receive devices for the next two (2) treatment weeks |
Visit 6: TP 4th week Time = 6 week | Review of possible adverse events t6 - CGI-S and Y-BOCS-BE scores |
Visit 7: TP 5th week Time = 7 week | Review of possible adverse events t7 - CGI-S and Y-BOCS-BE scores Return the devices of the preceding two (2) treatment weeks Receive devices for the subsequent three (3) treatment weeks |
Visit 8 TP 6th week Time = 8 week | Review of possible adverse events t8 - CGI-S and Y-BOCS-BE scores |
Visit 9: TP 7th week Time = 9 week | Review of possible adverse events t9 - CGI-S and Y-BOCS-BE scores |
Visit 10: 8th weekend of TP Time = 10 week | Review of possible adverse events Physical examination Drawing of laboratory blood samples for safety testing Return the devices of the preceding three (3) treatment weeks t10 - CGI-S and Y-BOCS-BE scores Weight measurement |