Trial Outcomes & Findings for Topiramate in Adolescents With Severe Obesity (NCT NCT01859013)

NCT ID: NCT01859013

Last Updated: 2017-07-02

Results Overview

The Percent Change from Baseline in Body Mass Index at 28-Weeks

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 34 participants
• Primary outcome timeframe: Baseline and 28-Weeks
• Results posted on: 2017-07-02

Participant Flow

34 subjects enrolled and 30 were started on the study medication or placebo

Participant milestones

Measure	Topiramate Four (4) weeks of meal replacement therapy, followed by 28-weeks of topiramate therapy. Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks. Topiramate: Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks. Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose for the remainder of the trial.	Sugar Pill Four (4) weeks of meal replacement therapy, followed by 28-weeks of placebo (sugar pill) therapy. Placebo: Placebo will be taken orally once daily in the evening for the first two weeks, and orally twice daily (AM and PM) for the remainder of the study.
Overall Study STARTED	16	14
Overall Study COMPLETED	12	9
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Topiramate in Adolescents With Severe Obesity

Baseline characteristics by cohort

Measure	Topiramate n=16 Participants Four (4) weeks of meal replacement therapy, followed by 28-weeks of topiramate therapy. Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks. Topiramate: Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks. Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose for the remainder of the trial.	Sugar Pill n=14 Participants Four (4) weeks of meal replacement therapy, followed by 28-weeks of placebo (sugar pill) therapy. Placebo: Placebo will be taken orally once daily in the evening for the first two weeks, and orally twice daily (AM and PM) for the remainder of the study.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	14.9 years STANDARD_DEVIATION 1.6 • n=5 Participants	15.7 years STANDARD_DEVIATION 1.8 • n=7 Participants	15.2 years STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	14 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 28-Weeks

The Percent Change from Baseline in Body Mass Index at 28-Weeks

Outcome measures

Measure	Topiramate n=16 Participants Four (4) weeks of meal replacement therapy, followed by 28-weeks of topiramate therapy. Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks. Topiramate: Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks. Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose for the remainder of the trial.	Sugar Pill n=14 Participants Four (4) weeks of meal replacement therapy, followed by 28-weeks of placebo (sugar pill) therapy. Placebo: Placebo will be taken orally once daily in the evening for the first two weeks, and orally twice daily (AM and PM) for the remainder of the study.
Percent Change From Baseline in Body Mass Index at 28-Weeks	-2.74 % change BMI Standard Deviation 3.74	-0.85 % change BMI Standard Deviation 5.31

Adverse Events

Topiramate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sugar Pill

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

Claudia Fox

University of Minnesota

Phone: 612-626-6616

Email: lusc0001@umn.edu

Results disclosure agreements

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