Primary Insomnia
Conditions
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
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
| Measure | Time frame |
|---|---|
| Mean of total sleep time over 2 nights. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean of other PSG sleep parameters over 2 nights, mean of subjective sleep parameters, and exploratory residual effect. | — |
Outcome results
None listed