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Central Nervous System Stimulant

Solriamfetol for Excessive Sleepiness

Phase 4
Recruiting
Led By Charles A Czeisler, PhD,MD
Research Sponsored by Charles Andrew Czeisler, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male participants must agree to refrain from donating sperm and agree to remain abstinent from heterosexual intercourse or to use a male condom with female partners who are on an additional highly effective contraceptive method, both during the study and for at least 30 days after the last dose of study medication
Female participants must either be of non-childbearing potential or using a highly effective contraceptive method and agree to continue its use for at least 30 days after the last dose of study medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline segment (weeks 1-2 of study) and treatment segment 2 (weeks 5-6 of study)
Awards & highlights

Study Summary

This trial is testing whether the medication Solriamfetol can help people who start work early in the morning feel less sleepy during the day.

Who is the study for?
This trial is for adults aged 18-64 who work early morning shifts (3 AM-6 AM) at least 3 days a week and have excessive sleepiness related to shift work. They must not be pregnant, breastfeeding, or have significant health issues like kidney problems or unstable heart conditions. Participants should not use certain medications that affect sleepiness and agree to avoid alcohol, nicotine, and caffeine before tests.Check my eligibility
What is being tested?
Researchers are testing Solriamfetol Oral Tablet against a placebo to see if it helps with daytime sleepiness in people who start work between 3 and 6 am. The study involves taking the medication or placebo and monitoring how it affects their alertness during the day.See study design
What are the potential side effects?
While specific side effects of Solriamfetol aren't listed here, common ones may include headache, nausea, insomnia, anxiety; however individual reactions can vary. Placebo typically has no active ingredients but some individuals might report symptoms due to expectation effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to not donate sperm and to either not have sex or use a condom and additional birth control with female partners during and for 30 days after the study.
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I am either unable to have children or I am using effective birth control and will continue for 30 days after the last dose.
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I feel very sleepy because of my early morning work shifts.
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I am not pregnant or breastfeeding.
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I am between 18 and 64 years old.
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I work at least 20 hours a week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline segment (weeks 1-2 of study) and treatment segment 2 (weeks 5-6 of study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline segment (weeks 1-2 of study) and treatment segment 2 (weeks 5-6 of study) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Objective Sleepiness
Secondary outcome measures
Change in Clinician's Global Impression
Change in Patient's Global Impression of Change
Change in Subjective Sleepiness on KSS
Other outcome measures
Change in Excessive Daytime Sleepiness
Change in Subjective Global Functioning on FOSQ-10
Change in Subjective Global Functioning on SDS
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Solriamfetol (Sunosi)Experimental Treatment1 Intervention
Participants will start at 75 mg and take that dose for 3 consecutive days. Participants will take their first 75mg dose on an early morning work day and take the next two 75 mg doses upon awakening regardless of their work schedule. They will then move to 150mg on the next early morning work day and for all subsequent early morning shift work days. The drug/placebo will be taken orally within 30 minutes after awakening, before the start of each early morning shift. Prior to the end of study of visit (Visit 5), drug will be taken at home within 30 minutes of awakening.
Group II: ControlPlacebo Group1 Intervention
Participants randomized into the Control arm will receive a placebo

Find a Location

Who is running the clinical trial?

Charles Andrew Czeisler, MD, PhDLead Sponsor
Axsome Therapeutics, Inc.Industry Sponsor
27 Previous Clinical Trials
7,742 Total Patients Enrolled
Charles A. Czeisler, PhD, MDLead Sponsor

Media Library

Solriamfetol Oral Tablet (Central Nervous System Stimulant) Clinical Trial Eligibility Overview. Trial Name: NCT04788953 — Phase 4
Shift Work Sleep Disorder Research Study Groups: Solriamfetol (Sunosi), Control
Shift Work Sleep Disorder Clinical Trial 2023: Solriamfetol Oral Tablet Highlights & Side Effects. Trial Name: NCT04788953 — Phase 4
Solriamfetol Oral Tablet (Central Nervous System Stimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04788953 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being recruited for this experiment?

"Yes, the trial is still recruiting patients. According to clinicaltrials.gov, it was initially launched on July 21st 2021 and most recently renewed on May 23rd 2022. A total of 110 participants are needed from 1 site for this medical research program."

Answered by AI

Are further participants being sought for this trial?

"Taking into account the information posted on clinicaltrials.gov, this investigation is in search of participants. The trial was initially unveiled on July 21st 2021 and underwent its most recent update on May 23rd 2022."

Answered by AI

Would I be eligible to become a participant in this research project?

"This study requires 110 participants aged 18-64 that suffer from somnolence. Additional eligibility criteria include: both male and female adults, ≥ 20 hours of work per week, 6 to 12 hour shifts, 3 months’ experience with early morning starts (3 AM -6AM) minimum, women must not be pregnant or nursing infants; BMI between 18.5 kg/m2 and 45 kg/m2."

Answered by AI

Is this a pioneering experiment of its kind?

"Currently, 3 trials of Solriamfetol Oral Tablet are being conducted in 2 cities and 1 nation. These investigations were first initiated by Jazz Pharmaceuticals in 2021 and included 64 participants in its final Phase 4 clinical trial stage. Since then, a total of 18335 studies have been completed for the drug product."

Answered by AI

Has the Solriamfetol Oral Tablet received regulatory assent from the FDA?

"With a score of 3, our team at Power consider Solriamfetol Oral Tablet to be safe as this is an approved Phase 4 trial."

Answered by AI

Is there any previous research surrounding the efficacy of Solriamfetol Oral Tablet?

"Currently, Solriamfetol Oral Tablet is the subject of 3 active trials with 1 in its third phase. The majority of tests are located near Boston, Massachusetts although there are other sites conducting studies as well."

Answered by AI

Is geriatric participation accepted in this trial?

"According to the available data, only individuals aged 18-64 are eligible for this trial. However, there is a total of 7 different trials targeted towards younger patients and 22 specifically designed for elderly citizens."

Answered by AI
~3 spots leftby Apr 2024