A Long-Term Study Continuing on From Study 04-001-01 of an Experimental Medication in Adults With Anxiety Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Long-Term, Open Label, Safety and Efficacy Study of an Experimental Medication in Adults With Generalized Anxiety Disorder (GAD)

Conditions
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Anxiety Disorder

Intervention / Treatment
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* Drug: a benzodiazepine drug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: a benzodiazepine drug|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the long-term efficacy of open-label study of the experimental drug in subjects with GAD |  |  | 
| Assessment of the long-term effects on the quality of life, social and occupational functioning, sleep, and daytime sedation in subjects with GAD |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Generalized Anxiety Disorder