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Evaluate the Safety of GABITRIL in Adults With Generalized Anxiety Disorder

Primary Purpose

General Anxiety Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
GABITRIL (tiagabine hydrochloride; CEP-6671)
Sponsored by
Cephalon
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for General Anxiety Disorder

Eligibility Criteria

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

Not available at time of registration

Sites / Locations

  • Pivotal Research Center
  • Southwestern Research
  • Pharmacology Research Institut
  • Pharmacology Research Institut
  • Pacific Clinical Research Medi
  • Radiant Research San Diego
  • Affiliated Research Institute
  • Radiant Research Denver
  • University of Connecticut
  • Clinical Neuroscience Solution
  • Clinical Neuroscience Solution
  • Carman Research
  • Cunningham Clinical Research
  • Massachusetts General Hospital
  • Summit Research Network Farmin
  • CNS Research Institute
  • Social Psychiatry Research Ins
  • Fieve Clinical Services, Inc.
  • Medical and Behavioral
  • Medical Research Network
  • Richard Weisler, MD and Assoc
  • Summit Research Network Inc.
  • University of Pennsylvania
  • South East Health Consultants
  • Claghorn-Lesem Research
  • Radiant Research Salt Lake
  • Comprehensive Neuroscience Of
  • Summit Seattle Boren

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 27, 2005
Last Updated
April 11, 2023
Sponsor
Cephalon
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1. Study Identification

Unique Protocol Identification Number
NCT00233675
Brief Title
Evaluate the Safety of GABITRIL in Adults With Generalized Anxiety Disorder
Official Title
A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety of GABITRIL at Dosages up to 16mg/Day in Adults With Generalized Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cephalon

4. Oversight

5. Study Description

Brief Summary
To assess the long-term safety and tolerability of tiagabine treatment in patients with generalized anxiety disorder (GAD).

6. Conditions and Keywords

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

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 (tiagabine hydrochloride; CEP-6671)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Not available at time of registration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Brown, MD
Organizational Affiliation
Cephalon
Official's Role
Study Director
Facility Information:
Facility Name
Pivotal Research Center
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
Southwestern Research
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Pharmacology Research Institut
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Pharmacology Research Institut
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Pacific Clinical Research Medi
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Radiant Research San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Affiliated Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92108
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
Clinical Neuroscience Solution
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Clinical Neuroscience Solution
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Carman Research
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Cunningham Clinical Research
City
Edwardsville
State/Province
Illinois
ZIP/Postal Code
62025
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Summit Research Network Farmin
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Facility Name
CNS Research Institute
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
Social Psychiatry Research Ins
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
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
Richard Weisler, MD and Assoc
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Summit Research Network Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
South East Health Consultants
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Claghorn-Lesem Research
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
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
Comprehensive Neuroscience Of
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22041
Country
United States
Facility Name
Summit Seattle Boren
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

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Evaluate the Safety of GABITRIL in Adults With Generalized Anxiety Disorder

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