Zonisamide for Weight Reduction in Obese Adults

Obesity Clinical Trial

Official title:

Zonisamide for Weight Reduction in Obese Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00275834
• Other study ID #: Pro00005514
• Secondary ID: R01DK0673521-RO1
• Status: Completed
• Phase: N/A
• First received: January 10, 2006
• Last updated: July 9, 2014
• Start date: January 2006
• Est. completion date: September 2011

Study information

• Verified date: February 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The primary aim of this study is to assess long-term weight loss efficacy of zonisamide relative to placebo in obese patients prescribed a dietary intervention.

Description:

This RCT compares two doses of zonisamide and placebo for one year. A total of 225 subjects are randomly assigned to one of the three treatment interventions at Duke University Medical Centre. The primary outcome measure is change in body weight in kilograms. Secondary outcomes include changes in waist circumference, glycaemic and inflammatory markers, lipids, food craving, hunger and satiety, quality of life, blood pressure and heart rate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria: Age 18-65 years; BMI 30-50

Exclusion Criteria:

Secondary obesity; Significant cardiovascular disease; Stroke, seizure disorder or other significant neurological disease; Significant liver or gallbladder disease; Significant renal disease or history of kidney stones; HIV positive status; Diabetes mellitus; Untreated or unstable hypothyroidism Malignancy in the past 5 years; Concomitant medications that cause significant weight gain or weight loss; Concomitant use of prescription or OTC weight loss medications; Had bariatric surgery or planning surgery in the next 1 year; Weight change of more than 4 kg in the past 3 months; Suicidal subjects; Major depression in the past 6 months; History of psychosis, bipolar disorder, or severe personality disorders; Subjects taking antipsychotics or mood stabilisers; Alcohol or substance abuse in the past 6 months; Currently taking zonisamide or other antiepileptic drugs; History of hypersensitivity to zonisamide or sulfonamides; Pregnant or planning pregnancy in the next year, or breastfeeding; Severe physical disability; Current participation in a commercial weight loss program or planning to participate; Currently following low-carbohydrate, high protein, high fat diet; Use of investigational medications or devices (current or past 4 weeks)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Drug:
• Zonisamide
zonisamide 400 mg, 200 mg, or placebo

Locations

Country	Name	City	State
United States	Duke University Medical Centre	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gadde KM, Kopping MF, Wagner HR 2nd, Yonish GM, Allison DB, Bray GA. Zonisamide for weight reduction in obese adults: a 1-year randomized controlled trial. Arch Intern Med. 2012 Nov 12;172(20):1557-64. doi: 10.1001/2013.jamainternmed.99. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Weight	The primary endpoint was weight loss at 1-year, Month-12 weight minus baseline weight, in kilograms.	1 year	No
Secondary	Proportions of Patients With 5% Weight Loss	These were the proportions of patients losing 5% or more weight at 1-year relative to baseline. The measures were modeled with logistic regressions that included the three-level group proxy and a baseline weight covariate.	1 year	No
Secondary	Proportions of Patients With 10% Weight Loss	This outcomes measure followed the same principles at measurement of proportions of patients with 5% weight loss described elsewhere.	1 year	No
Secondary	Waist Circumference	Analyses was based on intent-to-treat ANCOVA. Difference scores from baseline to endpoint (Month-12) for each measure were regressed on the three-level proxy denoting group while controlling for the baseline value of the same measure. Contrasts were subsequently estimated in models, which had a significant overall treatment effect.	1 year	No
Secondary	Inflammatory Markers		1 year	No
Secondary	Lipids		1 year	No
Secondary	Quality of Life		1 year	No
Secondary	Psychological Measures		1 year	No
Secondary	Blood Pressure		1 year	No