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

Phase 3CompletedNCT00094627

H. Lundbeck A/S465 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

465

Conditions

Primary Insomnia

Interventions

gaboxadolDRUG

Duration of Treatment - 6 weeks

Comparator: placebo (unspecified)DRUG

Duration of Treatment - 6 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: After 2 days

Secondary Outcomes

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

Time frame: After 30 days

Amount of deep sleep after 2 days

Time frame: After 2 days

Data from ClinicalTrials.gov

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