Status:
COMPLETED
Staccato Loxapine in Agitated Patients With Bipolar Disorder
Lead Sponsor:
Alexza Pharmaceuticals, Inc.
Conditions:
Bipolar I Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients.
Detailed Description
This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2 dose levels of Staccato Loxapine, 5 and 10 mg. Patients may receive up to 3 doses of study drug in a 24-hour...
Eligibility Criteria
Inclusion
- Male and female adult patients with bipolar 1 disorder and acute agitation
Exclusion
- Agitation caused primarily by acute intoxication
- History of drug or alcohol dependence
- Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug administration
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT00721955
Start Date
July 1 2008
End Date
October 1 2008
Last Update
July 26 2017
Active Locations (6)
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1
Synergy Escondido
Escondido, California, United States, 92025
2
Collaborative NeuroScience Network, Inc.
Garden Grove, California, United States, 92845
3
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
4
FutureSearch Trials
Austin, Texas, United States, 78756