Trial intelligence / Profile preview

Gaboxadol Phase IIb in Primary Insomnia

NCT00266344Phase 2

Key facts

Status: Completed
Start: Nov 2005
Sponsor: Lundbeck
Modality: Small Molecules

Drugs: gaboxadol
Conditions: Insomnia

Overview

Phase 2, randomised, double-blind trial in Insomnia comparing Gaboxadol with Placebo (2 arms). Primary endpoint: Patient-reported total sleep time at 3 weeks. Started Nov 2005; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Gaboxadol
Gaboxadol (MK-0928) at various doses
Placebo
Placebo comparator

Who it enrols

Patients with a diagnosis of primary insomnia, excluding those with active psychiatric disorders other than primary insomnia.

Endpoints

Primary

Patient-reported total sleep time3 weeks

Secondary

Patient-reported time to sleep onset3 weeks
Number of awakenings3 weeks
Wake time after sleep onset3 weeks
Premature awakening3 weeks

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