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This study aims to assess the efficacy of IN 10 003 in improving sleep parameters in patients with Insomnia exhibiting both difficulty in falling asleep and staying asleep. The study will compare 2 formulations of the IN 10 003 to placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | IN 10 003 formulation A |
|
| 2 | Active Comparator | IN 10 003 formulation B |
|
| 3 | Placebo Comparator | Placebo capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IN 10 003 formulation A | Drug |
| ||
| IN 10 003 formulation B |
| Measure | Description | Time Frame |
|---|---|---|
| Wake after sleep onset | To determine the effect of IN 10 003 on Wake time After Sleep Onset (WASO) as the change from baseline for the mean of night 1 and 2 relative to placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Objective and Subjective sleep parameters | Total Sleep Time, Latency to Persistent Sleep, Absence of residual effects, |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka University Medical Center | Beersheba | Israel | ||||
| Rambam Medical Center |
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| Placebo capsules | Drug |
|
| Haifa |
| Israel |
| Assuta Medical Center | Tel Aviv | Israel |