Somnum Pharma Inc.
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.
This clinical trial aims to evaluate if SOM001 is safe and well tolerated, and if it helps to improve sleep in adults with insomnia. Up to 45 adults (ages 18 to 65) will be asked to participate in the study. The study will be conducted in the participants' home environment and all visits will be remote using phone and video calls. The study will include 3 main phases: 1. Screening period to evaluate eligibility in the trial. It may include up to 4 visits and testing of sleep monitoring devices at home. If a person is not eligible, this will end their participation in the study. There will b…
Inclusion Criteria: 1. Willing and able to provide informed consent prior to initiation of study procedures 2. Males and females, ages 18-65 years (inclusive) 3. Willing to use a highly effective method of contraception for the duration of the study (see Section 9.8.1) for more details on acceptable forms of contraceptives) 4. Can follow directions and comply with schedule of visits 5. Has a valid email address 6. Has access to a mobile device and Wi-Fi and is willing to download required applications on their own device 7. Has a computer with a keyboard for study questionnaires 8. Diagnosis…
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
Arctuva estimate
Actual pay is set by the research site.
Verify or correct the compensation shown for this listing.