Skip to content

Sleep Laboratory Study of MK0928 in Adult Patients With Primary Insomnia (0928-041)(TERMINATED)

MK0928 Phase II Sleep Laboratory Study - Primary Insomnia

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00266357
Enrollment
50
Registered
2005-12-16
Start date
2005-11-30
Completion date
Unknown
Last updated
2015-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Insomnia

Brief summary

A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.

Interventions

DRUGMK0928, gaboxadol / Duration of Treatment: 6 days for treatment periods (2 days/dose)
DRUGPlacebo / Duration of Treatment: 2 days for screening period

Sponsors

H. Lundbeck A/S
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

* Patients with a diagnosis of primary insomnia

Exclusion criteria

* Patients with an active psychiatric disorder other than primary insomnia

Design outcomes

Primary

MeasureTime frame
Mean of total sleep time over 2 nights.

Secondary

MeasureTime frame
Mean of other PSG sleep parameters over 2 nights, mean of subjective sleep parameters, and exploratory residual effect.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026