A Study of Oral SOM001 as a Safe and Effective Treatment for Adults With Chronic Insomnia in a Randomized, Controlled, Dose-finding Study
Public ClinicalTrials.gov record NCT07920185. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Phase 2a, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability, and Efficacy of Oral SOM001 in Adults With Chronic Insomnia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this clinical trial is to learn if SOM001 is safe and well tolerated in adults with insomnia. It will also evaluate if it helps to improve sleep. The main questions this trial aims to answer are: 1. Is SOM001 associated with any side-effects 2. Do people tolerate SOM001 well 3. Is SOM001 helpful to improve sleep Researchers will compare SOM001 to a placebo (a look-alike substance that contains no drug) as well as to 2 other well-established medications that are often used to treat sleep. Participants will: 1. Take one of the drugs, or placebo for 3 nights each week, for 3 weeks. The drugs will be pre-assigned and change each week. 2. Be asked questions about their sleep and overall health, including mental health 3. Complete tests to evaluate their memory and alertness on the computer 4. Use monitors at night to evaluate their sleep quality and activity. This will be a virtual study and participants will connect with the study team via video and phone calls for training and check-ups during the study.
Study identification
- NCT ID
- NCT07920185
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 45 participants
Conditions and interventions
Conditions
Interventions
- Low Dose Drug A Drug
- Low Dose Drug B Drug
- High Dose Drug A Drug
- High Dose Drug B Drug
- SOM001-A Drug
- SOM001-B Drug
- SOM001-C Drug
- SOM001-D Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 1, 2027 (Estimated)
- Primary completion
- Oct 1, 2027 (Estimated)
- Completion
- Feb 1, 2028 (Estimated)
- Last update posted
- Nov 5, 2026
2027 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 4 East 70th Street, 9a | New York | New York | 10021 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07920185, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 5, 2026 · Synced Nov 6, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07920185 live on ClinicalTrials.gov.