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SOM001 for Chronic Insomnia

PT
Overseen ByPatricia Tolete
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Somnum Pharma Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults who have chronic insomnia, meaning they regularly have trouble falling asleep. Participants should be generally healthy and able to take part in a virtual study from home.

Inclusion Criteria

Willing and able to provide informed consent prior to initiation of study procedures
Modified Insomnia Severity Index (ISI) of 7 or higher
Has a valid email address
See 8 more

Exclusion Criteria

Any other condition that would pose a health risk or interfere with evaluation or interpretation of study results per Investigator's opinion
Non-English-speaking participants
I have an unstable heart rhythm problem.
See 31 more

What Are the Treatments Tested in This Trial?

Interventions

  • SOM001-A
  • SOM001-B
  • SOM001-C
  • SOM001-D

Trial Overview

The study tests different doses of a new oral drug called SOM001 against placebo (no active drug) and two commonly used sleep medications. Each participant tries several treatments over three weeks to see which works best and is safest.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: SOM001-C and SOM001-DExperimental Treatment2 Interventions
Group II: SOM001-A and SOM001-BExperimental Treatment2 Interventions
Group III: Drug AActive Control2 Interventions
Group IV: Drug BActive Control2 Interventions
Group V: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Somnum Pharma Inc.

Lead Sponsor

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