Zonisamide for Weight Reduction in Obese Adults

This study has been completed.

Sponsor:

Collaborator:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Information provided by (Responsible Party):

Duke University

ClinicalTrials.gov Identifier:

NCT00275834

First received: January 10, 2006

Last updated: February 7, 2013

Last verified: February 2013

History of Changes

Results First Received: December 10, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Obesity
Intervention:	Drug: Zonisamide

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
The study was conducted at Duke University Medical Center between 2006 and 2011.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Placebo	Zonisamide 100 mg and placebo capsules were prepared in accordance with Good Manufacturing Practice (GMP) guidelines in Duke Compounding Facility with active pharmaceutical ingredient (Sochinaz SA, Switzerland, distributed by Bachem Americas, King of Prussia, Pennsylvania) plus dextrose as an inactive ingredient. Identical-looking placebo capsules contained dextrose. Each capsule contained zonisamide 100 mg or placebo, with patients and study staff blinded to contents. Dose was gradually titrated upward as follows: 1 capsule for 15 days, 2 during days 16-30, 3 capsules during days 31-45, and 4 from day 46 onward. The entire dose was taken at night. Blinded dose reduction was allowed and dose increase could be withheld. Patients had the option to discontinue the drug and remain in the study receiving only diet and lifestyle counseling.
Zonisamide 200 mg	Dosing of matching placebo was identical.
Zonisamide 400 mg	No text entered.

Description

Placebo

Zonisamide 100 mg and placebo capsules were prepared in accordance with Good Manufacturing Practice (GMP) guidelines in Duke Compounding Facility with active pharmaceutical ingredient (Sochinaz SA, Switzerland, distributed by Bachem Americas, King of Prussia, Pennsylvania) plus dextrose as an inactive ingredient. Identical-looking placebo capsules contained dextrose.

Each capsule contained zonisamide 100 mg or placebo, with patients and study staff blinded to contents. Dose was gradually titrated upward as follows: 1 capsule for 15 days, 2 during days 16-30, 3 capsules during days 31-45, and 4 from day 46 onward. The entire dose was taken at night. Blinded dose reduction was allowed and dose increase could be withheld. Patients had the option to discontinue the drug and remain in the study receiving only diet and lifestyle counseling.

Zonisamide 200 mg

Dosing of matching placebo was identical.

Zonisamide 400 mg

No text entered.

Participant Flow: Overall Study

	Placebo	Zonisamide 200 mg	Zonisamide 400 mg
STARTED	74	76	75
COMPLETED	71	73	74
NOT COMPLETED	3	3	1

Baseline Characteristics

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Reporting Groups

	Description
Placebo	No text entered.
Zonisamide 200 mg	No text entered.
Zonisamide 400 mg	No text entered.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Zonisamide 200 mg	Zonisamide 400 mg	Total
Number of Participants [units: participants]	74	76	75	225
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	74	76	75	225
>=65 years	0	0	0	0
Age [units: years] Mean ± Standard Deviation	43.5 ± 10.3	44.2 ± 10.1	42.3 ± 10.0	43.4 ± 10.1
Gender [units: participants]
Female	44	45	45	134
Male	30	31	30	91
Region of Enrollment [units: participants]
United States	74	76	75	225

Outcome Measures

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1. Primary:

Change in Body Weight [ Time Frame: 1 year ]

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2. Secondary:

Proportions of Patients With 5% Weight Loss [ Time Frame: 1 year ]

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3. Secondary:

Proportions of Patients With 10% Weight Loss [ Time Frame: 1 year ]

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4. Secondary:

Waist Circumference [ Time Frame: 1 year ]

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5. Secondary:

Inflammatory Markers [ Time Frame: 1 year ]