A Study of Oral SOM001 as a Safe and Effective Treatment for Adults With Chronic Insomnia
NCT07920185, Phase 2, Not yet recruiting, Somnum Pharma Inc.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study of Oral SOM001 as a Safe and Effective Treatment for Adults With Chronic Insomnia | ClinicalTrials.gov |
| NCT number | NCT07920185 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 45 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Somnum Pharma Inc. | ClinicalTrials.gov |
| Conditions | Chronic Insomnia | ClinicalTrials.gov |
| Interventions | Low Dose Drug A, Low Dose Drug B, High Dose Drug A, High Dose Drug B, SOM001-A, SOM001-B, SOM001-C, SOM001-D, Placebo | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of participants with treatment-related adverse events at 3 weeks after SOM001 intervention as compared to placebo | 3 weeks | ClinicalTrials.gov | |
| Primary | Incidence, severity, and relationship of adverse events (AEs) after SOM001 intervention as compared to placebo | 3 weeks | ClinicalTrials.gov | |
| Primary | Incidence of serious adverse events (SAEs) after SOM001 intervention as compared to placebo | 3 weeks | ClinicalTrials.gov | |
| Secondary | Changes in Wake After Sleep Onset (WASO) after SOM001 intervention as compared to placebo | 3 weeks | ClinicalTrials.gov | |
| Secondary | Changes in Latency to Persistent Sleep (LPS) after SOM001 intervention as compared to placebo | 3 weeks | ClinicalTrials.gov | |
| Secondary | Changes in Total Sleep Time (TST) after SOM001 intervention as compared to placebo | 3 weeks | ClinicalTrials.gov | |
| Other | Changes in Karolinska Sleepiness Scale (KSS) score after SOM001 intervention as compared to placebo | 3 weeks | This is a validated 9-point scale employed to measure the perceived level of sleepiness at a point in time. A higher score indicates greater sleepiness. | ClinicalTrials.gov |
| Other | Changes in Patient Global Impression-Severity (PGI-S) score after SOM001 intervention as compared to placebo | 3 weeks | This is a single-item patient-rated questionnaire of insomnia severity. Patients will select one of six response options with the highest option indicating greater insomnia severity. | ClinicalTrials.gov |
| Other | Changes in cognitive function and alertness by Cognitive Test - Symbol Digit Coding (SDC) after SOM001 intervention as compared to placebo | 3 weeks | This is scored from 1 to 99 with higher scores indicating better performance. | ClinicalTrials.gov |
| Other | Changes in WASO after SOM001 intervention as compared to Drug A | 3 weeks | ClinicalTrials.gov | |
| Other | Changes in LPS after SOM001 intervention as compared to Drug A | 3 weeks | ClinicalTrials.gov | |
| Other | Changes in TST after SOM001 intervention as compared to Drug A | 3 weeks | ClinicalTrials.gov | |
| Other | Changes in WASO after SOM001 intervention as compared to Drug B | 3 weeks | ClinicalTrials.gov | |
| Other | Changes in LPS after SOM001 intervention as compared to Drug B | 3 weeks | ClinicalTrials.gov | |
| Other | Changes in TST after SOM001 intervention as compared to Drug B | 3 weeks | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)