ACT-078573 in Elderly Subjects With Chronic Primary Insomnia - Full Text View

Sponsored by:	Actelion
Information provided by:	Actelion
ClinicalTrials.gov Identifier:	NCT00606593

Purpose

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

Condition	Intervention	Phase
Chronic Primary Insomnia	Drug: ACT-078573 oral capsules at 25 and 100 mg and matching placebo Drug: almorexant and matching placebo	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by Actelion:

Primary Outcome Measures:

Mean wake time after sleep onset. [ Time Frame: 2 treatment nights ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean total sleep time. [ Time Frame: 2 treatment nights. ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	December 2007
Study Completion Date:	August 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ABECD: Experimental 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo	Drug: ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover: sequences: ABECD, BCADE, CDBEA, DECAB, EADBC DCEBA, EDACB, AEBDC, BACED, CBDAE Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
BCADE: Experimental 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo	Drug: almorexant and matching placebo ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
CDBEA: Experimental 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo	Drug: almorexant and matching placebo ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
DECAB: Experimental 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo	Drug: almorexant and matching placebo ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
EADBC: Experimental 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo	Drug: almorexant and matching placebo ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
DCEBA: Experimental 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo	Drug: almorexant and matching placebo ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
EDACB: Experimental 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo	Drug: almorexant and matching placebo ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
AEBDC: Experimental 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo	Drug: almorexant and matching placebo ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
BACED: Experimental 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo	Drug: almorexant and matching placebo ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
CBDAE: Experimental 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo	Drug: almorexant and matching placebo ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

History of any sleep disorder, or any 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606593

Locations

United States, Arkansas
Central Arkansas Research
Hot Springs, Arkansas, United States, 71913
United States, California
Pacific Sleep Medicine Services, Inc.
San Diego, California, United States, 92121
Pacific Sleep Medicine Services, Inc.
Los Angeles, California, United States, 90048
California Clinical Trials Medical Group, Inc.
San Diego, California, United States, 92123
United States, Florida
OmniTrials
Naples, Florida, United States, 34110
PAB Clinical Research
Brandon, Florida, United States, 33511
Miami Research Associates
Miami, Florida, United States, 33173
Broward Research Group & Sleep-Wake Disorders Center of South Florida
Pembroke Pines, Florida, United States, 33026
United States, Georgia
Sleep Disorders Center of Georgia
Atlanta, Georgia, United States, 30342
Neurotrials Research, Inc.
Atlanta, Georgia, United States, 30342
United States, Kansas
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66212
United States, Kentucky
Community Research
Crestview Hills, Kentucky, United States, 41017
United States, Michigan
Clinical Neurophysiology Services, P.C.
Troy, Michigan, United States, 48098
United States, Missouri
Sleep Disorders & Research Center
Chesterfield, Missouri, United States, 63017
United States, Nevada
Clinical Research Center of Nevada
Las Vegas, Nevada, United States, 89104
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Tri-State Sleep Disorders Center
Cincinnati, Ohio, United States, 45227
Cleveland Clinic Health Systems
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Lynn Health Sciences Institute
Oklahoma City, Oklahoma, United States, 73112
United States, South Carolina
Sleep Disorders Center
Columbia, South Carolina, United States, 29201
United States, Texas
Sleep Medicine Associates P.A.
Dallas, Texas, United States, 75231

Sponsors and Collaborators

Actelion

Investigators

Principal Investigator:

James K. Walsh, PhD

Sleep Medicine and Research Center

More Information

Responsible Party:	Actelion ( Paul Yeung, MD, Vice President, Head of US Clinical Science )
Study ID Numbers:	AC-057A201
Study First Received:	January 4, 2008
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00606593
Health Authority:	United States: Food and Drug Administration

Keywords provided by Actelion:

insomnia
elderly
sleeplessness

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Signs and Symptoms
Mental Disorders

Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2009