Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults With Generalized Anxiety Disorder.
Sponsor
Cephalon (Industry)
Overall Status
Completed
CT.gov ID
NCT00214994
Collaborator
(none)
93
23
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date
:
Jan 1, 2005
Study Completion Date
:
Dec 1, 2006
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham Research Group | Birmingham | Alabama | United States | 35216 |
| 2 | Pivotal Research Center | Mesa | Arizona | United States | 85210 |
| 3 | Pivotal Research | Peoria | Arizona | United States | 85381 |
| 4 | Southwestern Research | Beverly Hills | California | United States | 90210 |
| 5 | Valley Clinical Research | El Centro | California | United States | 92243 |
| 6 | Irvine Center for Clinical Res | Irvine | California | United States | 92618 |
| 7 | Pharmacology Research Institute | Los Alamitos | California | United States | 90720 |
| 8 | Pacific Institue for Medical | Los Angeles | California | United States | 90024 |
| 9 | Pharmacology Research Institute | Newport Beach | California | United States | 92660 |
| 10 | Pacific Clinical Research Medi | Orange | California | United States | 92868 |
| 11 | Pharmacology Research Institute | Riverside | California | United States | 92506 |
| 12 | Affiliated Research Institute | San Diego | California | United States | 92108 |
| 13 | HealthQuest Clinical Trials | San Diego | California | United States | 92123 |
| 14 | Clinical Innovations Inc. | Santa Ana | California | United States | 92705 |
| 15 | Radiant Research Denver | Denver | Colorado | United States | 80212 |
| 16 | University of Connecticut | Farmington | Connecticut | United States | 06030 |
| 17 | University of Florida | Jacksonville | Florida | United States | 32257 |
| 18 | Miami Research Associates | Miami | Florida | United States | 33173 |
| 19 | Medicial Research Group of Central Florida | Orange City | Florida | United States | 32763 |
| 20 | Clinical Neuroscience Solution | Orlando | Florida | United States | 32806 |
| 21 | Roskamp Institute | Sarasota | Florida | United States | 34243 |
| 22 | Stedman Clinical Trials | Tampa | Florida | United States | 33613 |
| 23 | Clinical Neuroscience Solution | West Palm Beach | Florida | United States | 33407 |
| 24 | Atlanta Institue of Medicaine | Atlanta | Georgia | United States | 30328 |
| 25 | Emory University | Atlanta | Georgia | United States | 30329 |
| 26 | Carman Research | Smyrna | Georgia | United States | 30080 |
| 27 | Hawaii Clinical Research | Honolulu | Hawaii | United States | 96826 |
| 28 | American Medical Research | Aurora | Illinois | United States | 60506 |
| 29 | Cunningham Clinical Research | Edwardsville | Illinois | United States | 62025 |
| 30 | Henry Lahmeyer, MD | Northfield | Illinois | United States | 60093 |
| 31 | Midwest Center for Neurobehavi | Oakbrook Terrace | Illinois | United States | 60181 |
| 32 | Indiana University | Indianapolis | Indiana | United States | 46202 |
| 33 | Vince and Associates Clinical | Overland Park | Kansas | United States | 66211 |
| 34 | Hartford Research Ltd | Florence | Kentucky | United States | 41042 |
| 35 | Pedia Research, LLC | Owensboro | Kentucky | United States | 42301 |
| 36 | Four Rivers Clinical Research | Paducah | Kentucky | United States | 42003 |
| 37 | LSUHSC New Orleans | New Orleans | Louisiana | United States | 70115 |
| 38 | LSUHSC in Shreveport | Shreveport | Louisiana | United States | 71130-3932 |
| 39 | Capital Clinical Research Asso | Rockville | Maryland | United States | 20852 |
| 40 | Dupont Clinical Research | Rockville | Maryland | United States | 20852 |
| 41 | University of Massachusetts | Worcester | Massachusetts | United States | 01655 |
| 42 | Wayne State University | Detroit | Michigan | United States | 48207 |
| 43 | Summit Research Network Farmin | Farmington Hills | Michigan | United States | 48336 |
| 44 | Summit Research Network Michig | Okemos | Michigan | United States | 48864 |
| 45 | Regions Hospital | St. Paul | Minnesota | United States | 55101 |
| 46 | Radiant Research Las Vegas | Las Vegas | Nevada | United States | 89146-5611 |
| 47 | CNS Research Institute | Clementon | New Jersey | United States | 08021 |
| 48 | Center for Emotional Fitness | Moorestown | New Jersey | United States | 08057 |
| 49 | University of New Mexico | Albuquerque | New Mexico | United States | 87131-5311 |
| 50 | Social Psychiatry Research Ins | Brooklyn | New York | United States | 11235 |
| 51 | Neurobehavioral Research, Inc. | Lawrence | New York | United States | 11559 |
| 52 | Eastside Comprehensive Medical | New York | New York | United States | 10021 |
| 53 | Fieve Clinical Services, Inc. | New York | New York | United States | 10021 |
| 54 | Medical and Behavioral | New York | New York | United States | 10023 |
| 55 | Medical Research Network | New York | New York | United States | 10024 |
| 56 | Behavioral Medical Research | Staten Island | New York | United States | 10305 |
| 57 | Medark Clinical Trials and Research | Morganton | North Carolina | United States | 28655 |
| 58 | Richard Weisler, MD and Assoc | Raleigh | North Carolina | United States | 27609 |
| 59 | Wake Research Associates | Raleigh | North Carolina | United States | 27612 |
| 60 | North Coast Clinical Trials | Beechwood | Ohio | United States | 44122 |
| 61 | Hartford Research Group | Cincinnati | Ohio | United States | 45242 |
| 62 | Midwest Clinical Research Ctr | Dayton | Ohio | United States | 45408 |
| 63 | University of Oklahoma | Oklahoma City | Oklahoma | United States | 73104 |
| 64 | Pahl Pharmaceutical Research | Oklahoma City | Oklahoma | United States | 73118 |
| 65 | OCCI Eugene | Eugene | Oregon | United States | 97401 |
| 66 | Summit Research Network Inc. | Portland | Oregon | United States | 97210 |
| 67 | OCCI, Inc. | Salem | Oregon | United States | 97309 |
| 68 | Keystone Clinical Studies LLC | Norristown | Pennsylvania | United States | 19401 |
| 69 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 70 | CNS Research Institute PC | Philadelphia | Pennsylvania | United States | 19149 |
| 71 | South East Health Consultants | Charleston | South Carolina | United States | 29407 |
| 72 | Carolina Clinical Research Ser | Columbia | South Carolina | United States | 29201 |
| 73 | Clinical Neuroscience Solution | Memphis | Tennessee | United States | 38119 |
| 74 | FutureSearch Trials | Austin | Texas | United States | 78703 |
| 75 | Claghorn-Lesem Research | Bellaire | Texas | United States | 77401 |
| 76 | UT Southwestern Medical Center | Dallas | Texas | United States | 75235 |
| 77 | Fabre Research Clinics, Inc. | Houston | Texas | United States | 77004 |
| 78 | R D Clinical Research | Lake Jackson | Texas | United States | 77566 |
| 79 | Croft Group Research Center | San Antonio | Texas | United States | 78229 |
| 80 | Radiant Research Salt Lake | Salt Lake City | Utah | United States | 84107 |
| 81 | University of Utah | Salt Lake City | Utah | United States | 84132 |
| 82 | Comprehensive Neuroscience Of | Arlington | Virginia | United States | 22201 |
| 83 | Northwest Clinical Research | Bellevue | Washington | United States | 98004 |
| 84 | Summit Seattle Boren | Seattle | Washington | United States | 98104 |
| 85 | Northbrook Research Center | Brown Deer | Wisconsin | United States | 53223 |
| 86 | Dean Foundation | Middleton | Wisconsin | United States | 53562 |
| 87 | University of Alberta | Edmonton | Alberta | Canada | T6G 2C8 |
| 88 | University of British Columbia | Vancouver | British Columbia | Canada | V6T 2A1 |
| 89 | St. Boniface General Hospital | Winnipeg | Manitoba | Canada | R2H 2A6 |
| 90 | McMaster University Medical Ce | Hamilton | Ontario | Canada | L8N 3Z5 |
| 91 | Center for Addiction and Mental Health, Mood and Anxiety Program | Toronto | Ontario | Canada | M5t 1R8 |
| 92 | Mood & Anxiety Disorders Ctr | Toronto | Ontario | Canada | M5T 1R8 |
| 93 | Clinique Marie-Fitzbach | Quebec | Canada | G1R 2W8 |
Sponsors and Collaborators
- Cephalon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00214994
Other Study ID Numbers:
- C6671/3033/AX/US
First Posted:
Sep 22, 2005
Last Update Posted:
May 9, 2014
Last Verified:
May 1, 2014