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

Midnight Pharma

Status and phase

Completed

Phase 2

Conditions

Chronic Primary Insomnia

Treatments

Drug: ACT-078573 oral capsules at 25 and 100 mg and matching placebo

Drug: ACT-078573 and matching placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00606593

AC-057A201

Details and patient eligibility

About

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.

Enrollment

112 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

112 participants in 10 patient groups

ABECD

Experimental group

Description:

5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Treatment:

Drug: ACT-078573 oral capsules at 25 and 100 mg and matching placebo

BCADE

Experimental group

Description:

5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Treatment:

Drug: ACT-078573 and matching placebo

CDBEA

Experimental group

Description:

5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Treatment:

Drug: ACT-078573 and matching placebo

DECAB

Experimental group

Description:

5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Treatment:

Drug: ACT-078573 and matching placebo

EADBC

Experimental group

Description:

5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Treatment:

Drug: ACT-078573 and matching placebo

DCEBA

Experimental group

Description:

5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Treatment:

Drug: ACT-078573 and matching placebo

EDACB

Experimental group

Description:

5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Treatment:

Drug: ACT-078573 and matching placebo

AEBDC

Experimental group

Description:

5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Treatment:

Drug: ACT-078573 and matching placebo

BACED

Experimental group

Description:

5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Treatment:

Drug: ACT-078573 and matching placebo

CBDAE

Experimental group

Description:

5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

Treatment:

Drug: ACT-078573 and matching placebo

Trial contacts and locations

Data sourced from clinicaltrials.gov

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