A Long-Term Study Continuing on From Study 04-001-01 of an Experimental Medication in Adults With Anxiety Disorder
- Conditions
- Anxiety Disorder
- Registration Number
- NCT00106860
- Lead Sponsor
- Jazz Pharmaceuticals
- Brief Summary
The purpose of the study is to assess the safety and effectiveness of the experimental drug, a benzodiazepine drug, in long-term use and the effects on quality of life, social and occupational functioning, sleep, and daytime sedation in subjects with anxiety disorder.
- Detailed Description
This trial is a long-term, open label, safety and efficacy study of an experimental medication in adults with Generalized Anxiety Disorder (GAD). To enroll in this study, investigators and patients must have first participated in Jazz Pharmaceuticals, Inc. Protocol 04-001-01. The study is designed for four stages that should last a total of 37 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 158
- Complete Study 04-001-01
- Able to take the medication for 9 months
- Understand and sign the Informed Consent
- Comply with all study-related procedures
- Women of child bearing potential must have a confirmed negative urine pregnancy test
- Lack of clinically significant abnormalities in health
- Experienced any SAEs (serious adverse events) that were related or possibly related to study drug during participation in Study 04-001-01
- Early termination from study 04-001-01
- Any new condition that could interfere with the evaluation of the subject, interpretation of safety data, or compliance with the protocol requirements
- Experiencing AEs (adverse events) such that in the opinion of the investigator, per protocol, study drug administration or safe participation in this study would be precluded.
- Taken any disallowed medications noted in Study 04-001-01 between the completion of Study 04-001-01 and entry into this trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Assessment (over 37 additional weeks following the double-blind study) of the safety of the experimental drug in long-term use in subjects with Generalized Anxiety Disorder (GAD)
- Secondary Outcome Measures
Name Time Method Assessment of the long-term effects on the quality of life, social and occupational functioning, sleep, and daytime sedation in subjects with GAD Evaluate the long-term efficacy of open-label study of the experimental drug in subjects with GAD
Trial Locations
- Locations (12)
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Center for Clinical Research, Inc.
🇺🇸Eugene, Oregon, United States
Florida Clinical Research Center
🇺🇸Bradenton, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Jacksonville, Florida, United States
Meridien Research
🇺🇸St. Petersburg, Florida, United States
CNS Research Institute (CRI)
🇺🇸Philadelphia, Pennsylvania, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
Future Search Trials
🇺🇸Austin, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Comprehensive Neuroscience of Northern Virginia
🇺🇸Falls Church, Virginia, United States
Neurology and NeuroscienceCenter of Ohio
🇺🇸Toledo, Ohio, United States