Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia

PHASE2CompletedINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

April 30, 2008

Study Completion Date

May 31, 2008

Conditions
Chronic Primary Insomnia
Interventions
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

DRUG

ACT-078573 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

DRUG

ACT-078573 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

DRUG

ACT-078573 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

DRUG

ACT-078573 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

DRUG

ACT-078573 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

DRUG

ACT-078573 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

DRUG

ACT-078573 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

DRUG

ACT-078573 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

DRUG

ACT-078573 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

Trial Locations (21)

27710

Duke University, Durham

29201

Sleep Disorders Center, Columbia

30342

Neurotrials Research, Inc., Atlanta

Sleep Disorders Center of Georgia, Atlanta

33026

Broward Research Group & Sleep-Wake Disorders Center of South Florida, Pembroke Pines

33173

Miami Research Associates, Miami

33511

PAB Clinical Research, Brandon

34110

OmniTrials, Naples

41017

Community Research, Crestview Hills

44195

Cleveland Clinic Health Systems, Cleveland

45227

Tri-State Sleep Disorders Center, Cincinnati

48098

Clinical Neurophysiology Services, P.C., Troy

63017

Sleep Disorders & Research Center, Chesterfield

66212

Vince and Associates Clinical Research, Overland Park

71913

Central Arkansas Research, Hot Springs

73112

Lynn Health Sciences Institute, Oklahoma City

75231

Sleep Medicine Associates P.A., Dallas

89104

Clinical Research Center of Nevada, Las Vegas

90048

Pacific Sleep Medicine Services, Inc., Los Angeles

92121

Pacific Sleep Medicine Services, Inc., San Diego

92123

California Clinical Trials Medical Group, Inc., San Diego

Sponsors
All Listed Sponsors
lead

Midnight Pharma, LLC

INDUSTRY