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

Midnight Pharma, LLC112 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

112

Conditions

Chronic Primary Insomnia

Interventions

ACT-078573 oral capsules at 25 and 100 mg and matching placeboDRUG

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

ACT-078573 and matching placeboDRUG

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

ACT-078573 and matching placeboDRUG

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

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (21)

Central Arkansas Research

Hot Springs, Arkansas, United States

Outcomes

Primary Outcomes

Mean Wake Time After Sleep Onset (WASO)

WASO was the time in minutes scored as wake between the onset of persistent sleep and lights on, where the onset of persistent sleep was the beginning of the first continuous 20 epochs (10 min) scored as non-wake. Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable due to protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the WASO was missing (e.g., persistent sleep did not occur), the missing value was substituted with the highest value recorded for the subject during the study (single-blind period included).

Time frame: 2 treatment nights

Secondary Outcomes

Mean Total Sleep Time (TST)

TST was the amount of actual sleep time measured in minutes scored as non-wake (i.e., sleep stage 1, 2, slow-wave sleep, or rapid eye movement (sleep)). Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable by protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the TST was missing (e.g., the subject did not sleep or persistent sleep did not occur), the missing value was substituted with the worst value recorded for the subject during the study (single-blind period included).

Time frame: 2 treatment nights

Data from ClinicalTrials.gov

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