Anxiety DisordersPhase 3NCT00214994
Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults With Generalized Anxiety Disorder.
A Phase 3 study testing Gabitril in people with Anxiety Disorders, run by Cephalon at 93 sites in 2 countries.
Trial summary
A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults with Generalized Anxiety Disorder. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Gabitril
- How many people
- Not given
- Where
- 93 sitesin 2 countries
- Study dates
- Jan 2005to Dec 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
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).
Trial locations and contacts
93 sites in 2 countries.
93 sites in 2 countries
United States86 sites
University of New Mexico
Albuquerque, New Mexico, 87131-5311
Comprehensive Neuroscience Of
Arlington, Virginia, 22201
Atlanta Institue of Medicaine
Atlanta, Georgia, 30328
Emory University
Atlanta, Georgia, 30329
American Medical Research
Aurora, Illinois, 60506
FutureSearch Trials
Austin, Texas, 78703
North Coast Clinical Trials
Beechwood, Ohio, 44122
Claghorn-Lesem Research
Bellaire, Texas, 77401
Northwest Clinical Research
Bellevue, Washington, 98004
Southwestern Research
Beverly Hills, California, 90210
Birmingham Research Group
Birmingham, Alabama, 35216
Social Psychiatry Research Ins
Brooklyn, New York, 11235
Northbrook Research Center
Brown Deer, Wisconsin, 53223
South East Health Consultants
Charleston, South Carolina, 29407
Hartford Research Group
Cincinnati, Ohio, 45242
CNS Research Institute
Clementon, New Jersey, 08021
Carolina Clinical Research Ser
Columbia, South Carolina, 29201
UT Southwestern Medical Center
Dallas, Texas, 75235
Midwest Clinical Research Ctr
Dayton, Ohio, 45408
Radiant Research Denver
Denver, Colorado, 80212
Wayne State University
Detroit, Michigan, 48207
Cunningham Clinical Research
Edwardsville, Illinois, 62025
Valley Clinical Research
El Centro, California, 92243
OCCI Eugene
Eugene, Oregon, 97401
University of Connecticut
Farmington, Connecticut, 06030
Summit Research Network Farmin
Farmington Hills, Michigan, 48336
Hartford Research Ltd
Florence, Kentucky, 41042
Hawaii Clinical Research
Honolulu, Hawaii, 96826
Fabre Research Clinics, Inc.
Houston, Texas, 77004
Indiana University
Indianapolis, Indiana, 46202
Irvine Center for Clinical Res
Irvine, California, 92618
University of Florida
Jacksonville, Florida, 32257
R D Clinical Research
Lake Jackson, Texas, 77566
Radiant Research Las Vegas
Las Vegas, Nevada, 89146-5611
Neurobehavioral Research, Inc.
Lawrence, New York, 11559
Pharmacology Research Institute
Los Alamitos, California, 90720
Pacific Institue for Medical
Los Angeles, California, 90024
Clinical Neuroscience Solution
Memphis, Tennessee, 38119
Pivotal Research Center
Mesa, Arizona, 85210
Miami Research Associates
Miami, Florida, 33173
Dean Foundation
Middleton, Wisconsin, 53562
Center for Emotional Fitness
Moorestown, New Jersey, 08057
Medark Clinical Trials and Research
Morganton, North Carolina, 28655
LSUHSC New Orleans
New Orleans, Louisiana, 70115
Eastside Comprehensive Medical
New York, New York, 10021
Fieve Clinical Services, Inc.
New York, New York, 10021
Medical and Behavioral
New York, New York, 10023
Medical Research Network
New York, New York, 10024
Pharmacology Research Institute
Newport Beach, California, 92660
Keystone Clinical Studies LLC
Norristown, Pennsylvania, 19401
Henry Lahmeyer, MD
Northfield, Illinois, 60093
Midwest Center for Neurobehavi
Oakbrook Terrace, Illinois, 60181
Summit Research Network Michig
Okemos, Michigan, 48864
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Pahl Pharmaceutical Research
Oklahoma City, Oklahoma, 73118
Pacific Clinical Research Medi
Orange, California, 92868
Medicial Research Group of Central Florida
Orange City, Florida, 32763
Clinical Neuroscience Solution
Orlando, Florida, 32806
Vince and Associates Clinical
Overland Park, Kansas, 66211
Pedia Research, LLC
Owensboro, Kentucky, 42301
Four Rivers Clinical Research
Paducah, Kentucky, 42003
Pivotal Research
Peoria, Arizona, 85381
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
CNS Research Institute PC
Philadelphia, Pennsylvania, 19149
Summit Research Network Inc.
Portland, Oregon, 97210
Richard Weisler, MD and Assoc
Raleigh, North Carolina, 27609
Wake Research Associates
Raleigh, North Carolina, 27612
Pharmacology Research Institute
Riverside, California, 92506
Capital Clinical Research Asso
Rockville, Maryland, 20852
Dupont Clinical Research
Rockville, Maryland, 20852
Regions Hospital
Saint Paul, Minnesota, 55101
OCCI, Inc.
Salem, Oregon, 97309
Radiant Research Salt Lake
Salt Lake City, Utah, 84107
University of Utah
Salt Lake City, Utah, 84132
Croft Group Research Center
San Antonio, Texas, 78229
Affiliated Research Institute
San Diego, California, 92108
HealthQuest Clinical Trials
San Diego, California, 92123
Clinical Innovations Inc.
Santa Ana, California, 92705
Roskamp Institute
Sarasota, Florida, 34243
Summit Seattle Boren
Seattle, Washington, 98104
LSUHSC in Shreveport
Shreveport, Louisiana, 71130-3932
Carman Research
Smyrna, Georgia, 30080
Behavioral Medical Research
Staten Island, New York, 10305
Stedman Clinical Trials
Tampa, Florida, 33613
Clinical Neuroscience Solution
West Palm Beach, Florida, 33407
University of Massachusetts
Worcester, Massachusetts, 01655
Canada7 sites
University of Alberta
Edmonton, Alberta, T6G 2C8
McMaster University Medical Ce
Hamilton, Ontario, L8N 3Z5
Clinique Marie-Fitzbach
Québec, Quebec, G1R 2W8
Center for Addiction and Mental Health, Mood and Anxiety Program
Toronto, Ontario, M5t 1R8
Mood & Anxiety Disorders Ctr
Toronto, Ontario, M5T 1R8
University of British Columbia
Vancouver, British Columbia, V6T 2A1
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
About this study
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.
A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults with Generalized Anxiety Disorder.
- Conditions
- Anxiety Disorders
- Being tested
- Gabitril
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabitrilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214994
- Sponsor's protocol ID
- C6671/3033/AX/US
- Status last verified
- May 2014
- First submitted
- 14 Sep 2005
- Last updated
- 9 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00214994
- Acronym / sponsor ID
- C6671/3033/AX/US
- Conditions
- Anxiety Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Study completion
- Dec 2006
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults with Generalized Anxiety Disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gabitril | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
93 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gabitril in people with Anxiety Disorders, run by Cephalon at 93 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2014.