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Completed

NCT Number: NCT00608985

Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia

A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.

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Key information

Conditions

Primary Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sleep Disorders Laboratory, Royal Adelaide Hospital, Adelaide, South Australia, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult subjects (18-64 years) with a diagnosis of primary insomnia.

Exclusion criteria

  • History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental Disorders, 4th edition (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.

Treatment and study plan

Almorexant

Drug

2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem

Placebo

Drug

2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem

zolpidem

Drug

2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated

Primary outcomes

  1. Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO)

    Time frame: From baseline to Day 1&2

    WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on.

    For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1&2 and Day 15&16

  2. Change From Baseline to Day 15&16 in WASO

    Time frame: From baseline to Day 15&16

    WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on.

    For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1&2 and Day 15&16

  3. Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO)

    Time frame: From baseline to Week 1&2

    sWASO was the self-reported time spent awake after sleep onset as reported in the sleep diary. For sWASO assessed at home, the mean of all available data collected between Visits 3 and 4 (i.e., after the second morning of Visit 3 and before the first evening of Visit 4) was used for Week 1&2

Secondary outcomes

  1. Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS)

    Time frame: From baseline to Day 1&2

    LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG

  2. Change From Baseline to Day 15&16 in LPS

    Time frame: From baseline to Day 15&16

    LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG

  3. Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO)

    Time frame: From baseline to Week 1&2

    sLSO was the self-reported time to fall asleep as reported in the sleep diary

Sponsors and collaborators

Lead sponsor

Midnight Pharma, LLC

Industry

Registry information

Official study title

Multi-center, Double-blind, Randomized, Placebo-controlled, Active Reference, Parallel-group Polysomnography Study to Assess the Efficacy and Safety of a 16-day Oral Administration of ACT-078573 in Adult Subjects With Chronic Primary Insomnia

Acronym: RESTORA 1

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 6, 2008
Registry last updated
Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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