Insomnia disorder
Conditions
Brief summary
Wake after sleep onset (WASO) assessed with polysomnography (PSG) for Day 1 and Day 2 data combined from Part 1 and Part 2, Latency to persistent sleep (LPS) assessed with polysomnography (PSG) for Day 1 and Day 2 data combined from Part 1 and Part 2
Detailed description
Adverse events (AEs), Heart rate (HR), Diastolic blood pressure (DBP), Systolic blood pressure (SBP), Mean arterial pressure (MAP), Orthostatic changes in blood pressure (BP), Morning sleepiness, Safety laboratory tests, Pharmacokinetic (PK) variables, WASO and LPS assessed with PSG for Day 1 and Day 2 data separately from Part 1 and Part 2; in Part 2 WASO and LPS assessed with PSG for Day 27 and Day 28
Interventions
DRUGODM-105 0.3 mg/ml oral solution
DRUGODM-105 0.05 mg/ml oral solution
DRUGODM-105 placebo oral solution
Sponsors
Orion Corporation
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AEs), Heart rate (HR), Diastolic blood pressure (DBP), Systolic blood pressure (SBP), Mean arterial pressure (MAP), Orthostatic changes in blood pressure (BP), Morning sleepiness, Safety laboratory tests, Pharmacokinetic (PK) variables, WASO and LPS assessed with PSG for Day 1 and Day 2 data separately from Part 1 and Part 2; in Part 2 WASO and LPS assessed with PSG for Day 27 and Day 28 | — |
Primary
| Measure | Time frame |
|---|---|
| Wake after sleep onset (WASO) assessed with polysomnography (PSG) for Day 1 and Day 2 data combined from Part 1 and Part 2, Latency to persistent sleep (LPS) assessed with polysomnography (PSG) for Day 1 and Day 2 data combined from Part 1 and Part 2 | — |
Countries
Finland, Germany, Poland
Outcome results
None listed