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 3 Weeks
DRUGPlacebo / Duration of Treatment 3 Weeks
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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 |
|---|---|
| Patient-reported total sleep time. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-reported time to sleep onset, number of awakenings, wake time after sleep onset and premature awakening. | — |
Outcome results
None listed