Clinical trial NCT00606593: Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia
Official title: Multicenter, Double-blind, Randomized, Placebo-controlled, 5-period, 5-treatment Crossover, Dose-finding Study to Evaluate the Efficacy and Safety of Oral Administration of ACT-078573 in Elderly Subjects With Chronic Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Primary Insomnia
Keywords: insomnia
elderly
sleeplessness
Lead sponsor: Midnight Pharma, LLC
Sponsor class: INDUSTRY
First posted: 2008-02-04
Enrollment: 112
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A 2-night polysomnography / 5-way cross-over study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in elderly subjects with primary insomnia.


Eligibility criteria: Inclusion Criteria:

* Elderly subjects (\> 64 years) with a diagnosis of primary insomnia.

Exclusion Criteria:

* History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental Disorders IV (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.

Primary outcomes:
measure: Mean Wake Time After Sleep Onset (WASO)
timeFrame: 2 treatment nights
Secondary outcomes:
measure: Mean Total Sleep Time (TST)
timeFrame: 2 treatment nights
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Central Arkansas Research
state: Arkansas
city: Los Angeles
country: United States
facility: Pacific Sleep Medicine Services, Inc.
state: California
city: San Diego
country: United States
facility: Pacific Sleep Medicine Services, Inc.
state: California
city: San Diego
country: United States
facility: California Clinical Trials Medical Group, Inc.
state: California
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Naples
country: United States
facility: OmniTrials
state: Florida
city: Pembroke Pines
country: United States
facility: Broward Research Group & Sleep-Wake Disorders Center of South Florida
state: Florida
city: Atlanta
country: United States
facility: Neurotrials Research, Inc.
state: Georgia
city: Atlanta
country: United States
facility: Sleep Disorders Center of Georgia
state: Georgia
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Crestview Hills
country: United States
facility: Community Research
state: Kentucky
city: Troy
country: United States
facility: Clinical Neurophysiology Services, P.C.
state: Michigan
city: Chesterfield
country: United States
facility: Sleep Disorders & Research Center
state: Missouri
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: Tri-State Sleep Disorders Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Health Systems
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Sciences Institute
state: Oklahoma
city: Columbia
country: United States
facility: Sleep Disorders Center
state: South Carolina
city: Dallas
country: United States
facility: Sleep Medicine Associates P.A.
state: Texas
Study officials:
affiliation: Sleep Medicine and Research Center
name: James K. Walsh, PhD
role: PRINCIPAL_INVESTIGATOR
References: