A Prospective Active-Reference Study of Gaboxadol in Primary Insomnia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

675 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2004-06-30

Brief Summary

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To evaluate the efficacy safety and tolerability of gaboxadol in primary insomnia

Detailed Description

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To compare the hypnotic efficacy and safety of different dose levels of gaboxadol with placebo in non-elderly patients with primary insomnia over two weeks of treatment

Conditions

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Primary Insomnia

Keywords

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Primary insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Gaboxadol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* diagnosis of Primary insomnia

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Please contact: Annelies van der Hammen Legters

Role: STUDY_DIRECTOR

H. Lundbeck A/S

Other Identifiers

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99775

Identifier Type: -

Identifier Source: org_study_id