Trial Outcomes & Findings for Vigabatrin and Insulin Sensitivity (NCT NCT04321395)

NCT ID: NCT04321395

Last Updated: 2025-01-14

Results Overview

Measured by hyperglycemic euglycemic clamp

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 4 participants
• Primary outcome timeframe: 3 weeks after initiation of treatment
• Results posted on: 2025-01-14

Participant Flow

Participant milestones

Measure	Vigabatrin Vigabatrin: Vigabatrin - Pill, 500 mg twice daily for 7 days (days 0-6), 1000 mg twice daily for 7 days (days 7-13), 1500 mg twice daily for 10 days (days 14-23), 1000 mg twice daily for 7 days (days 24-30), 500 mg twice daily for 7 days (days 31-37) and will discontinue treatment on day 38.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vigabatrin and Insulin Sensitivity

Baseline characteristics by cohort

Measure	Vigabatrin n=4 Participants Vigabatrin: Vigabatrin - Pill, 500 mg twice daily for 7 days (days 0-6), 1000 mg twice daily for 7 days (days 7-13), 1500 mg twice daily for 10 days (days 14-23), 1000 mg twice daily for 7 days (days 24-30), 500 mg twice daily for 7 days (days 31-37) and will discontinue treatment on day 38.
Age, Continuous	36.2 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants
Glucose infusion rate	6.61 (mg/kg FFM/min) STANDARD_DEVIATION 1.7 • n=5 Participants
2 Hour OGTT	139.5 mg/dL STANDARD_DEVIATION 7.9 • n=5 Participants
Oral Glucose Insulin Sensitivity	294 ml/min/m^2 of body surface area STANDARD_DEVIATION 56 • n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks after initiation of treatment

Measured by hyperglycemic euglycemic clamp

Outcome measures

Measure	Vigabatrin n=4 Participants Vigabatrin: Vigabatrin - Pill, 500 mg twice daily for 7 days (days 0-6), 1000 mg twice daily for 7 days (days 7-13), 1500 mg twice daily for 10 days (days 14-23), 1000 mg twice daily for 7 days (days 24-30), 500 mg twice daily for 7 days (days 31-37) and will discontinue treatment on day 38.
Insulin Sensitivity	6.82 mg/kg FFM/min Standard Deviation 1.7

SECONDARY outcome

Timeframe: 3 weeks after initiation of treatment

Measured by 75 gram oral glucose tolerance test

Outcome measures

Measure	Vigabatrin n=4 Participants Vigabatrin: Vigabatrin - Pill, 500 mg twice daily for 7 days (days 0-6), 1000 mg twice daily for 7 days (days 7-13), 1500 mg twice daily for 10 days (days 14-23), 1000 mg twice daily for 7 days (days 24-30), 500 mg twice daily for 7 days (days 31-37) and will discontinue treatment on day 38.
Oral Glucose Tolerance	155.5 mg/dL Standard Deviation 19.2

SECONDARY outcome

Timeframe: After 3 weeks on drug

Insulin sensitivity based on oral glucose tolerance. Values are calculated using glucose and insulin from a 3-hour 75 gram oral glucose tolerance test at 0, 2, and 3 hours. Higher values are indicate better insulin sensitivity.

Outcome measures

Measure	Vigabatrin n=4 Participants Vigabatrin: Vigabatrin - Pill, 500 mg twice daily for 7 days (days 0-6), 1000 mg twice daily for 7 days (days 7-13), 1500 mg twice daily for 10 days (days 14-23), 1000 mg twice daily for 7 days (days 24-30), 500 mg twice daily for 7 days (days 31-37) and will discontinue treatment on day 38.
Oral Glucose Insulin Sensitivity	294 ml/min/m^2 of body surface area Standard Deviation 56

Adverse Events

Experimental: Vigabatrin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Assistant Professor

Washington University in St. Louis

Phone: 314-362-8708

Email: ssfarabi@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place