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a benzodiazepine drug

Phase 3

Anxiety Disorder | Small molecule | Psychiatry |Jazz Pharmaceuticals plc|Last Updated: Jan 9, 2008

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment158

FDA Designations

No designations recorded

Clinical trial landscape

a benzodiazepine drug · 1 trial · 1 indication

Phase 3 1
NCT00106860A Long-Term Study Continuing on From Study 04-001-01 of an Experimental Medication in Adults With Anxiety DisorderAnxiety Disorder
COMPLETED158 Analytics
PHASE3COMPLETED
A Long-Term Study Continuing on From Study 04-001-01 of an Experimental Medication in Adults With Anxiety Disorder
Anxiety DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
a benzodiazepine drugDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites13

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 abn...

Countries:United States
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Frequently asked questions about a benzodiazepine drug

What is the benzodiazepine drug used for?

The benzodiazepine drug is used for anxiety disorder in adults. It is being developed as a small molecule treatment in the psychiatry therapeutic area. The drug is currently in Phase 3 clinical development, meaning it is investigational and has not yet been approved by regulatory authorities.

Who makes the benzodiazepine drug?

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is developing the benzodiazepine drug. The company is conducting clinical trials for this investigational treatment for anxiety disorder. The drug is in Phase 3 development, and Jazz Pharmaceuticals is the sponsor of the ongoing clinical program.

What phase is the benzodiazepine drug in?

The benzodiazepine drug is in Phase 3 clinical development for anxiety disorder. It is an investigational small molecule treatment that has not been approved by regulatory authorities. One Phase 3 clinical trial has been completed, and the drug remains under clinical investigation.

What clinical trials is the benzodiazepine drug in?

The benzodiazepine drug has one completed Phase 3 clinical trial, NCT00106860, titled "A Long-Term Study Continuing on From Study 04-001-01 of an Experimental Medication in Adults With Anxiety Disorder." This trial enrolled 158 participants in the United States and included healthy volunteers.

Is the benzodiazepine drug FDA approved?

The benzodiazepine drug is not FDA approved. It is an investigational treatment for anxiety disorder currently in Phase 3 clinical development. The completed Phase 3 trial, NCT00106860, evaluated the drug in adults, but the drug has not received regulatory approval.