Status:
COMPLETED
Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia
Lead Sponsor:
Midnight Pharma, LLC
Conditions:
Primary Insomnia
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief Summary
A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.
Eligibility Criteria
Inclusion
- Adult subjects (18-64 years) with a diagnosis of primary insomnia.
Exclusion
- History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) axis I disorder other than primary insomnia.
- Sleep apnea, or restless legs syndrome.
- Daytime napping of more than 1 hour per day.
- Important caffeine consumption, heavy tobacco use, alcohol or drug abuse within 2 years prior to the screening visit.
- Unwillingness to refrain from drugs, over-the-counter or herbal medication having an effect on sleep or behavior.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
709 Patients enrolled
Trial Details
Trial ID
NCT00608985
Start Date
March 1 2008
End Date
November 1 2009
Last Update
March 14 2016
Active Locations (91)
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1
Sleep Disorders Laboratory, Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
2
Monash Adult Sleep Center, Monash Medical Centre
Clayton, Victoria, Australia, 3168
3
Western Hospitpal, Private Bag
Footscray, Victoria, Australia, 3011
4
Institute for Breathing and Sleep (IBAS)
Heidelburg, Victoria, Australia, 3084