An Investigational Drug Study in Healthy Adult Volunteers in a Model of Insomnia (0928-007)

Phase 3WithdrawnNCT00102154

H. Lundbeck A/S

Overview

A study to evaluate the safety and effectiveness of an investigational drug for insomnia (a sleep disorder).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Insomnia

Interventions

MK0928, gaboxadol / Duration of Treatment: 10 monthsDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy adults who are between the ages of 18 and 64 Exclusion Criteria: * Adults who are diagnosed with insomnia

Outcomes

Primary Outcomes

4-hour advanced polysomnographic (PSG) recording session measuring wake time after sleep onset (WASO) and latency to persistent sleep (LPS); Safety and tolerability

Secondary Outcomes

Daily sleep diary for visual analogue sleep quality and number of night awakenings (sNAW)

Data from ClinicalTrials.gov

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