General Anxiety DisorderPhase 3NCT00233675
Evaluate the Safety of GABITRIL in Adults With Generalized Anxiety Disorder
A Phase 3 study testing GABITRIL (tiagabine hydrochloride; CEP-6671) in people with General Anxiety Disorder, run by Cephalon at 28 sites in United States.
Trial summary
To assess the long-term safety and tolerability of tiagabine treatment in patients with generalized anxiety disorder (GAD). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- General Anxiety Disorder
- What is being tested?
- GABITRIL (tiagabine hydrochloride; CEP-6671)
- How many people
- Not given
- Where
- 28 sitesUnited States
- Study dates
- Aug 2003to Feb 2005
- 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
Not available at time of registration
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Claghorn-Lesem Research
Bellaire, Texas, 77401
Southwestern Research
Beverly Hills, California, 90210
Massachusetts General Hospital
Boston, Massachusetts, 02114
Social Psychiatry Research Ins
Brooklyn, New York, 11235
South East Health Consultants
Charleston, South Carolina, 29407
CNS Research Institute
Clementon, New Jersey, 08021
Radiant Research Denver
Denver, Colorado, 80212
Cunningham Clinical Research
Edwardsville, Illinois, 62025
Comprehensive Neuroscience Of
Falls Church, Virginia, 22041
University of Connecticut
Farmington, Connecticut, 06030
Summit Research Network Farmin
Farmington Hills, Michigan, 48336
Clinical Neuroscience Solution
Jacksonville, Florida, 32216
Pivotal Research Center
Mesa, Arizona, 85210
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 Institut
Newport Beach, California, 92660
Pharmacology Research Institut
Northridge, California, 91324
Pacific Clinical Research Medi
Orange, California, 92868
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Summit Research Network Inc.
Portland, Oregon, 97210
Richard Weisler, MD and Assoc
Raleigh, North Carolina, 27609
Radiant Research Salt Lake
Salt Lake City, Utah, 84107
Radiant Research San Diego
San Diego, California, 92103
Affiliated Research Institute
San Diego, California, 92108
Summit Seattle Boren
Seattle, Washington, 98104
Carman Research
Smyrna, Georgia, 30080
Clinical Neuroscience Solution
West Palm Beach, Florida, 33407
About this study
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
To assess the long-term safety and tolerability of tiagabine treatment in patients with generalized anxiety disorder (GAD).
- Conditions
- General Anxiety Disorder
- Being tested
- GABITRIL (tiagabine hydrochloride; CEP-6671)
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GABITRIL (tiagabine hydrochloride; CEP-6671)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2005 (estimated)
- Study startAug 2003
- Primary completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Anxiety DisorderStudies 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)
- Responsible party
- Sponsor
- Investigators
- Charles Brown, MD, Study director, Cephalon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233675
- Sponsor's protocol ID
- C6671A/301/AX/US
- Status last verified
- Apr 2023
- First submitted
- 27 Sep 2005
- Last updated
- 12 Apr 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. 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 of GABITRIL at Dosages up to 16mg/Day in Adults With Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00233675
- Acronym / sponsor ID
- C6671A/301/AX/US
- Conditions
- General Anxiety Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Feb 2005 (actual)
- First posted
- 6 Oct 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.
To assess the long-term safety and tolerability of tiagabine treatment in patients with generalized anxiety disorder (GAD).
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 (tiagabine hydrochloride; CEP-6671) | 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 12 Apr 2023.
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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.
Charles Brown, MD study director
Cephalon
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GABITRIL (tiagabine hydrochloride; CEP-6671) in people with General Anxiety Disorder, run by Cephalon at 28 sites in United States.
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 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. 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 12 Apr 2023.