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Completed

NCT Number: NCT00094627

Adult Primary Insomnia Polysomnographic Study (0928-004)(COMPLETED)

The purpose of the study is to test the safety and effectiveness of the Investigational Drug on 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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients with a diagnosis of primary insomnia and in good physical and mental health

Exclusion criteria

  • Adult patients with other medical , neurological and sleep disorders

Treatment and study plan

Gaboxadol

Drug

Duration of Treatment - 6 weeks

Other names: MK0928

Comparator: Placebo (Unspecified)

Drug

Duration of Treatment - 6 weeks

Primary outcomes

  1. Amount of time spent awake and time to fall asleep at night after 2 days

    Time frame: After 2 days

Secondary outcomes

  1. Amount of time spent awake and time to fall asleep at night after 30 days

    Time frame: After 30 days

  2. Amount of deep sleep after 2 days

    Time frame: After 2 days

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 30-Night Polysomnographic Study of MK0928 in Adult Patients With Primary Insomnia

Important dates

Study start
2004
Study completion
2006
First posted
Oct 22, 2004
Registry last updated
Jan 14, 2015

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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