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

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Gabitril
Sponsored by
Cephalon
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Birmingham Research Group
  • Pivotal Research Center
  • Pivotal Research
  • Southwestern Research
  • Valley Clinical Research
  • Irvine Center for Clinical Res
  • Pharmacology Research Institute
  • Pacific Institue for Medical
  • Pharmacology Research Institute
  • Pacific Clinical Research Medi
  • Pharmacology Research Institute
  • Affiliated Research Institute
  • HealthQuest Clinical Trials
  • Clinical Innovations Inc.
  • Radiant Research Denver
  • University of Connecticut
  • University of Florida
  • Miami Research Associates
  • Medicial Research Group of Central Florida
  • Clinical Neuroscience Solution
  • Roskamp Institute
  • Stedman Clinical Trials
  • Clinical Neuroscience Solution
  • Atlanta Institue of Medicaine
  • Emory University
  • Carman Research
  • Hawaii Clinical Research
  • American Medical Research
  • Cunningham Clinical Research
  • Henry Lahmeyer, MD
  • Midwest Center for Neurobehavi
  • Indiana University
  • Vince and Associates Clinical
  • Hartford Research Ltd
  • Pedia Research, LLC
  • Four Rivers Clinical Research
  • LSUHSC New Orleans
  • LSUHSC in Shreveport
  • Capital Clinical Research Asso
  • Dupont Clinical Research
  • University of Massachusetts
  • Wayne State University
  • Summit Research Network Farmin
  • Summit Research Network Michig
  • Regions Hospital
  • Radiant Research Las Vegas
  • CNS Research Institute
  • Center for Emotional Fitness
  • University of New Mexico
  • Social Psychiatry Research Ins
  • Neurobehavioral Research, Inc.
  • Eastside Comprehensive Medical
  • Fieve Clinical Services, Inc.
  • Medical and Behavioral
  • Medical Research Network
  • Behavioral Medical Research
  • Medark Clinical Trials and Research
  • Richard Weisler, MD and Assoc
  • Wake Research Associates
  • North Coast Clinical Trials
  • Hartford Research Group
  • Midwest Clinical Research Ctr
  • University of Oklahoma
  • Pahl Pharmaceutical Research
  • OCCI Eugene
  • Summit Research Network Inc.
  • OCCI, Inc.
  • Keystone Clinical Studies LLC
  • University of Pennsylvania
  • CNS Research Institute PC
  • South East Health Consultants
  • Carolina Clinical Research Ser
  • Clinical Neuroscience Solution
  • FutureSearch Trials
  • Claghorn-Lesem Research
  • UT Southwestern Medical Center
  • Fabre Research Clinics, Inc.
  • R D Clinical Research
  • Croft Group Research Center
  • Radiant Research Salt Lake
  • University of Utah
  • Comprehensive Neuroscience Of
  • Northwest Clinical Research
  • Summit Seattle Boren
  • Northbrook Research Center
  • Dean Foundation
  • University of Alberta
  • University of British Columbia
  • St. Boniface General Hospital
  • McMaster University Medical Ce
  • Center for Addiction and Mental Health, Mood and Anxiety Program
  • Mood & Anxiety Disorders Ctr
  • Clinique Marie-Fitzbach

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 14, 2005
Last Updated
May 8, 2014
Sponsor
Cephalon
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1. Study Identification

Unique Protocol Identification Number
NCT00214994
Brief Title
Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults With Generalized Anxiety Disorder.
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 Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Cephalon

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gabitril

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Birmingham Research Group
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Pivotal Research Center
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
Pivotal Research
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Southwestern Research
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Valley Clinical Research
City
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
Facility Name
Irvine Center for Clinical Res
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Pharmacology Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Pacific Institue for Medical
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Pharmacology Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Pacific Clinical Research Medi
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Pharmacology Research Institute
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Affiliated Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
HealthQuest Clinical Trials
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Clinical Innovations Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Radiant Research Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80212
Country
United States
Facility Name
University of Connecticut
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
University of Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32257
Country
United States
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Medicial Research Group of Central Florida
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Clinical Neuroscience Solution
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Roskamp Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
Stedman Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Clinical Neuroscience Solution
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Atlanta Institue of Medicaine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Carman Research
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Hawaii Clinical Research
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
American Medical Research
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60506
Country
United States
Facility Name
Cunningham Clinical Research
City
Edwardsville
State/Province
Illinois
ZIP/Postal Code
62025
Country
United States
Facility Name
Henry Lahmeyer, MD
City
Northfield
State/Province
Illinois
ZIP/Postal Code
60093
Country
United States
Facility Name
Midwest Center for Neurobehavi
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Vince and Associates Clinical
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Hartford Research Ltd
City
Florence
State/Province
Kentucky
ZIP/Postal Code
41042
Country
United States
Facility Name
Pedia Research, LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Four Rivers Clinical Research
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
LSUHSC New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
LSUHSC in Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
Capital Clinical Research Asso
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Dupont Clinical Research
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48207
Country
United States
Facility Name
Summit Research Network Farmin
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Facility Name
Summit Research Network Michig
City
Okemos
State/Province
Michigan
ZIP/Postal Code
48864
Country
United States
Facility Name
Regions Hospital
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Radiant Research Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146-5611
Country
United States
Facility Name
CNS Research Institute
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
Center for Emotional Fitness
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-5311
Country
United States
Facility Name
Social Psychiatry Research Ins
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Neurobehavioral Research, Inc.
City
Lawrence
State/Province
New York
ZIP/Postal Code
11559
Country
United States
Facility Name
Eastside Comprehensive Medical
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Fieve Clinical Services, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Medical and Behavioral
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
Facility Name
Medical Research Network
City
New York
State/Province
New York
ZIP/Postal Code
10024
Country
United States
Facility Name
Behavioral Medical Research
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Medark Clinical Trials and Research
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Facility Name
Richard Weisler, MD and Assoc
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
North Coast Clinical Trials
City
Beechwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Hartford Research Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Midwest Clinical Research Ctr
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Pahl Pharmaceutical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
OCCI Eugene
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Summit Research Network Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
OCCI, Inc.
City
Salem
State/Province
Oregon
ZIP/Postal Code
97309
Country
United States
Facility Name
Keystone Clinical Studies LLC
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
CNS Research Institute PC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19149
Country
United States
Facility Name
South East Health Consultants
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Carolina Clinical Research Ser
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Clinical Neuroscience Solution
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
FutureSearch Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78703
Country
United States
Facility Name
Claghorn-Lesem Research
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Fabre Research Clinics, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
R D Clinical Research
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
Croft Group Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Radiant Research Salt Lake
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Comprehensive Neuroscience Of
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22201
Country
United States
Facility Name
Northwest Clinical Research
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Summit Seattle Boren
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Northbrook Research Center
City
Brown Deer
State/Province
Wisconsin
ZIP/Postal Code
53223
Country
United States
Facility Name
Dean Foundation
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2A1
Country
Canada
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
McMaster University Medical Ce
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Center for Addiction and Mental Health, Mood and Anxiety Program
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5t 1R8
Country
Canada
Facility Name
Mood & Anxiety Disorders Ctr
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada
Facility Name
Clinique Marie-Fitzbach
City
Quebec
ZIP/Postal Code
G1R 2W8
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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