NCT00275834

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2006

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

January 16, 2013

Completed
Last Updated

January 12, 2017

Status Verified

November 1, 2016

Enrollment Period

5.7 years

First QC Date

January 10, 2006

Results QC Date

December 10, 2012

Last Update Submit

November 15, 2016

Conditions

Obesity

Keywords

obesity treatmentweight lossantiobesity drugszonisamide

Outcome Measures

Primary Outcomes (1)

  • Change in Body Weight

    The primary endpoint was weight loss at 1-year, Month-12 weight minus baseline weight, in kilograms.

    1 year

Secondary Outcomes (7)

  • Proportions of Patients With 5% Weight Loss

    1 year

  • Proportions of Patients With 10% Weight Loss

    1 year

  • Waist Circumference

    1 year

  • Inflammatory Markers (CRP)

    1 year

  • Change in Lipids

    baseline, 1 year

  • +2 more secondary outcomes

Study Arms (3)

A

EXPERIMENTAL

Zonisamide 400 mg

Drug: Zonisamide

B

EXPERIMENTAL

Zonisamide 200 mg

Drug: Zonisamide

C

PLACEBO COMPARATOR

matching placebo

Drug: Zonisamide

Interventions

ZonisamideDRUG

zonisamide 400 mg, 200 mg, or placebo

ABC

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Centre

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

  • 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.

    PMID: 23147455BACKGROUND

  • Shin JH, Gadde KM, Ostbye T, Bray GA. Weight changes in obese adults 6-months after discontinuation of double-blind zonisamide or placebo treatment. Diabetes Obes Metab. 2014 Aug;16(8):766-8. doi: 10.1111/dom.12275. Epub 2014 Mar 10.

    PMID: 25123600DERIVED

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

Zonisamide

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsIsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Kishore Gadde
Organization
Duke University Medical Center
kishore.gadde@duke.edu
919-668-0208

Study Officials

  • Kishore M Gadde, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 12, 2006

Study Start

January 1, 2006

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

January 12, 2017

Results First Posted

January 16, 2013

Record last verified: 2016-11

Locations

US(1)