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Topiramate in Adolescents With Severe Obesity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01859013
First Posted: May 21, 2013
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
Results First Submitted: February 7, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Obesity, Morbid
Obesity
Weight Loss
Interventions: Drug: Topiramate
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
34 subjects enrolled and 30 were started on the study medication or placebo

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Topiramate   Sugar Pill
STARTED   16   14 
COMPLETED   12   9 
NOT COMPLETED   4   5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   Topiramate   Sugar Pill   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   14   30 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      16 100.0%      14 100.0%      30 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 14.9  (1.6)   15.7  (1.8)   15.2  (1.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      10  62.5%      9  64.3%      19  63.3% 
Male      6  37.5%      5  35.7%      11  36.7% 
Region of Enrollment 
[Units: Participants]
     
United States   16   14   30 


  Outcome Measures

1.  Primary:   Percent Change From Baseline in Body Mass Index at 28-Weeks   [ Time Frame: Baseline and 28-Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Claudia Fox
Organization: University of Minnesota
phone: 612-626-6616
e-mail: lusc0001@umn.edu



Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01859013     History of Changes
Other Study ID Numbers: 1304M31241
First Submitted: May 9, 2013
First Posted: May 21, 2013
Results First Submitted: February 7, 2017
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017