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Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults With Generalized Anxiety Disorder.

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anxiety Disorders

Intervention: Gabitril (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Cephalon

Summary

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

Clinical Details

Official title: A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Efficacy of GABITRIL Treatment (up to 16 mg/Day) in Adults With Generalized Anxiety Disorder.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

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).

Locations and Contacts

Clinique Marie-Fitzbach, Quebec G1R 2W8, Canada

Birmingham Research Group, Birmingham, Alabama 35216, United States

University of Alberta, Edmonton, Alberta T6G 2C8, Canada

Pivotal Research Center, Mesa, Arizona 85210, United States

Pivotal Research, Peoria, Arizona 85381, United States

University of British Columbia, Vancouver, British Columbia V6T 2A1, Canada

Southwestern Research, Beverly Hills, California 90210, United States

Valley Clinical Research, El Centro, California 92243, United States

Irvine Center for Clinical Res, Irvine, California 92618, United States

Pharmacology Research Institute, Los Alamitos, California 90720, United States

Pacific Institue for Medical, Los Angeles, California 90024, United States

Pharmacology Research Institute, Newport Beach, California 92660, United States

Pacific Clinical Research Medi, Orange, California 92868, United States

Pharmacology Research Institute, Riverside, California 92506, United States

Affiliated Research Institute, San Diego, California 92108, United States

HealthQuest Clinical Trials, San Diego, California 92123, United States

Clinical Innovations Inc., Santa Ana, California 92705, United States

Radiant Research Denver, Denver, Colorado 80212, United States

University of Connecticut, Farmington, Connecticut 06030, United States

University of Florida, Jacksonville, Florida 32257, United States

Miami Research Associates, Miami, Florida 33173, United States

Medicial Research Group of Central Florida, Orange City, Florida 32763, United States

Clinical Neuroscience Solution, Orlando, Florida 32806, United States

Roskamp Institute, Sarasota, Florida 34243, United States

Stedman Clinical Trials, Tampa, Florida 33613, United States

Clinical Neuroscience Solution, West Palm Beach, Florida 33407, United States

Atlanta Institue of Medicaine, Atlanta, Georgia 30328, United States

Emory University, Atlanta, Georgia 30329, United States

Carman Research, Smyrna, Georgia 30080, United States

Hawaii Clinical Research, Honolulu, Hawaii 96826, United States

American Medical Research, Aurora, Illinois 60506, United States

Cunningham Clinical Research, Edwardsville, Illinois 62025, United States

Henry Lahmeyer, MD, Northfield, Illinois 60093, United States

Midwest Center for Neurobehavi, Oakbrook Terrace, Illinois 60181, United States

Indiana University, Indianapolis, Indiana 46202, United States

Vince and Associates Clinical, Overland Park, Kansas 66211, United States

Hartford Research Ltd, Florence, Kentucky 41042, United States

Pedia Research, LLC, Owensboro, Kentucky 42301, United States

Four Rivers Clinical Research, Paducah, Kentucky 42003, United States

LSUHSC New Orleans, New Orleans, Louisiana 70115, United States

LSUHSC in Shreveport, Shreveport, Louisiana 71130-3932, United States

St. Boniface General Hospital, Winnipeg, Manitoba R2H 2A6, Canada

Capital Clinical Research Asso, Rockville, Maryland 20852, United States

Dupont Clinical Research, Rockville, Maryland 20852, United States

University of Massachusetts, Worcester, Massachusetts 01655, United States

Wayne State University, Detroit, Michigan 48207, United States

Summit Research Network Farmin, Farmington Hills, Michigan 48336, United States

Summit Research Network Michig, Okemos, Michigan 48864, United States

Regions Hospital, St. Paul, Minnesota 55101, United States

Radiant Research Las Vegas, Las Vegas, Nevada 89146-5611, United States

CNS Research Institute, Clementon, New Jersey 08021, United States

Center for Emotional Fitness, Moorestown, New Jersey 08057, United States

University of New Mexico, Albuquerque, New Mexico 87131-5311, United States

Social Psychiatry Research Ins, Brooklyn, New York 11235, United States

Neurobehavioral Research, Inc., Lawrence, New York 11559, United States

Eastside Comprehensive Medical, New York, New York 10021, United States

Fieve Clinical Services, Inc., New York, New York 10021, United States

Medical and Behavioral, New York, New York 10023, United States

Medical Research Network, New York, New York 10024, United States

Behavioral Medical Research, Staten Island, New York 10305, United States

Medark Clinical Trials and Research, Morganton, North Carolina 28655, United States

Richard Weisler, MD and Assoc, Raleigh, North Carolina 27609, United States

Wake Research Associates, Raleigh, North Carolina 27612, United States

North Coast Clinical Trials, Beechwood, Ohio 44122, United States

Hartford Research Group, Cincinnati, Ohio 45242, United States

Midwest Clinical Research Ctr, Dayton, Ohio 45408, United States

Pahl Pharmaceutical Research, Oklahoma City, Oklahoma 73118, United States

University of Oklahoma, Oklahoma City, Oklahoma 73104, United States

McMaster University Medical Ce, Hamilton, Ontario L8N 3Z5, Canada

Center for Addiction and Mental Health, Mood and Anxiety Program, Toronto, Ontario M5t 1R8, Canada

Mood & Anxiety Disorders Ctr, Toronto, Ontario M5T 1R8, Canada

OCCI Eugene, Eugene, Oregon 97401, United States

Summit Research Network Inc., Portland, Oregon 97210, United States

OCCI, Inc., Salem, Oregon 97309, United States

Keystone Clinical Studies LLC, Norristown, Pennsylvania 19401, United States

CNS Research Institute PC, Philadelphia, Pennsylvania 19149, United States

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

South East Health Consultants, Charleston, South Carolina 29407, United States

Carolina Clinical Research Ser, Columbia, South Carolina 29201, United States

Clinical Neuroscience Solution, Memphis, Tennessee 38119, United States

FutureSearch Trials, Austin, Texas 78703, United States

Claghorn-Lesem Research, Bellaire, Texas 77401, United States

UT Southwestern Medical Center, Dallas, Texas 75235, United States

Fabre Research Clinics, Inc., Houston, Texas 77004, United States

R D Clinical Research, Lake Jackson, Texas 77566, United States

Croft Group Research Center, San Antonio, Texas 78229, United States

Radiant Research Salt Lake, Salt Lake City, Utah 84107, United States

University of Utah, Salt Lake City, Utah 84132, United States

Comprehensive Neuroscience Of, Arlington, Virginia 22201, United States

Northwest Clinical Research, Bellevue, Washington 98004, United States

Summit Seattle Boren, Seattle, Washington 98104, United States

Northbrook Research Center, Brown Deer, Wisconsin 53223, United States

Dean Foundation, Middleton, Wisconsin 53562, United States

Additional Information

Starting date: January 2005
Last updated: May 8, 2014

Page last updated: August 20, 2015

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