NCT00214994

Brief Summary

A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults with Generalized Anxiety Disorder.

Trial Health

90
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2005

Geographic Reach
2 countries

93 active sites

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, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

May 9, 2014

Status Verified

May 1, 2014

First QC Date

September 14, 2005

Last Update Submit

May 8, 2014

Conditions

Interventions

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Subjects who have completed 10 weeks of double-blind treatment and the subsequent taper period in 1 of the 3 previous double-blind studies (studies C6671/3030/AX/US, C6671/3031/AX/US, or C6671/3032/AX/US).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (93)

Birmingham Research Group

Birmingham, Alabama, 35216, United States

Location

Pivotal Research Center

Mesa, Arizona, 85210, United States

Location

Pivotal Research

Peoria, Arizona, 85381, United States

Location

Southwestern Research

Beverly Hills, California, 90210, United States

Location

Valley Clinical Research

El Centro, California, 92243, United States

Location

Irvine Center for Clinical Res

Irvine, California, 92618, United States

Location

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

Pacific Institue for Medical

Los Angeles, California, 90024, United States

Location

Pharmacology Research Institute

Newport Beach, California, 92660, United States

Location

Pacific Clinical Research Medi

Orange, California, 92868, United States

Location

Pharmacology Research Institute

Riverside, California, 92506, United States

Location

Affiliated Research Institute

San Diego, California, 92108, United States

Location

HealthQuest Clinical Trials

San Diego, California, 92123, United States

Location

Clinical Innovations Inc.

Santa Ana, California, 92705, United States

Location

Radiant Research Denver

Denver, Colorado, 80212, United States

Location

University of Connecticut

Farmington, Connecticut, 06030, United States

Location

University of Florida

Jacksonville, Florida, 32257, United States

Location

Miami Research Associates

Miami, Florida, 33173, United States

Location

Medicial Research Group of Central Florida

Orange City, Florida, 32763, United States

Location

Clinical Neuroscience Solution

Orlando, Florida, 32806, United States

Location

Roskamp Institute

Sarasota, Florida, 34243, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

Clinical Neuroscience Solution

West Palm Beach, Florida, 33407, United States

Location

Atlanta Institue of Medicaine

Atlanta, Georgia, 30328, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Carman Research

Smyrna, Georgia, 30080, United States

Location

Hawaii Clinical Research

Honolulu, Hawaii, 96826, United States

Location

American Medical Research

Aurora, Illinois, 60506, United States

Location

Cunningham Clinical Research

Edwardsville, Illinois, 62025, United States

Location

Henry Lahmeyer, MD

Northfield, Illinois, 60093, United States

Location

Midwest Center for Neurobehavi

Oakbrook Terrace, Illinois, 60181, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Vince and Associates Clinical

Overland Park, Kansas, 66211, United States

Location

Hartford Research Ltd

Florence, Kentucky, 41042, United States

Location

Pedia Research, LLC

Owensboro, Kentucky, 42301, United States

Location

Four Rivers Clinical Research

Paducah, Kentucky, 42003, United States

Location

LSUHSC New Orleans

New Orleans, Louisiana, 70115, United States

Location

LSUHSC in Shreveport

Shreveport, Louisiana, 71130-3932, United States

Location

Capital Clinical Research Asso

Rockville, Maryland, 20852, United States

Location

Dupont Clinical Research

Rockville, Maryland, 20852, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

Wayne State University

Detroit, Michigan, 48207, United States

Location

Summit Research Network Farmin

Farmington Hills, Michigan, 48336, United States

Location

Summit Research Network Michig

Okemos, Michigan, 48864, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Radiant Research Las Vegas

Las Vegas, Nevada, 89146-5611, United States

Location

CNS Research Institute

Clementon, New Jersey, 08021, United States

Location

Center for Emotional Fitness

Moorestown, New Jersey, 08057, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131-5311, United States

Location

Social Psychiatry Research Ins

Brooklyn, New York, 11235, United States

Location

Neurobehavioral Research, Inc.

Lawrence, New York, 11559, United States

Location

Eastside Comprehensive Medical

New York, New York, 10021, United States

Location

Fieve Clinical Services, Inc.

New York, New York, 10021, United States

Location

Medical and Behavioral

New York, New York, 10023, United States

Location

Medical Research Network

New York, New York, 10024, United States

Location

Behavioral Medical Research

Staten Island, New York, 10305, United States

Location

Medark Clinical Trials and Research

Morganton, North Carolina, 28655, United States

Location

Richard Weisler, MD and Assoc

Raleigh, North Carolina, 27609, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

North Coast Clinical Trials

Beechwood, Ohio, 44122, United States

Location

Hartford Research Group

Cincinnati, Ohio, 45242, United States

Location

Midwest Clinical Research Ctr

Dayton, Ohio, 45408, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Pahl Pharmaceutical Research

Oklahoma City, Oklahoma, 73118, United States

Location

OCCI Eugene

Eugene, Oregon, 97401, United States

Location

Summit Research Network Inc.

Portland, Oregon, 97210, United States

Location

OCCI, Inc.

Salem, Oregon, 97309, United States

Location

Keystone Clinical Studies LLC

Norristown, Pennsylvania, 19401, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

CNS Research Institute PC

Philadelphia, Pennsylvania, 19149, United States

Location

South East Health Consultants

Charleston, South Carolina, 29407, United States

Location

Carolina Clinical Research Ser

Columbia, South Carolina, 29201, United States

Location

Clinical Neuroscience Solution

Memphis, Tennessee, 38119, United States

Location

FutureSearch Trials

Austin, Texas, 78703, United States

Location

Claghorn-Lesem Research

Bellaire, Texas, 77401, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Fabre Research Clinics, Inc.

Houston, Texas, 77004, United States

Location

R D Clinical Research

Lake Jackson, Texas, 77566, United States

Location

Croft Group Research Center

San Antonio, Texas, 78229, United States

Location

Radiant Research Salt Lake

Salt Lake City, Utah, 84107, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Comprehensive Neuroscience Of

Arlington, Virginia, 22201, United States

Location

Northwest Clinical Research

Bellevue, Washington, 98004, United States

Location

Summit Seattle Boren

Seattle, Washington, 98104, United States

Location

Northbrook Research Center

Brown Deer, Wisconsin, 53223, United States

Location

Dean Foundation

Middleton, Wisconsin, 53562, United States

Location

University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

Location

University of British Columbia

Vancouver, British Columbia, V6T 2A1, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

McMaster University Medical Ce

Hamilton, Ontario, L8N 3Z5, Canada

Location

Center for Addiction and Mental Health, Mood and Anxiety Program

Toronto, Ontario, M5t 1R8, Canada

Location

Mood & Anxiety Disorders Ctr

Toronto, Ontario, M5T 1R8, Canada

Location

Clinique Marie-Fitzbach

Québec, Quebec, G1R 2W8, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Tiagabine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Nipecotic AcidsAcids, HeterocyclicHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

January 1, 2005

Study Completion

December 1, 2006

Last Updated

May 9, 2014

Record last verified: 2014-05

Locations