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Orexin Antagonist

Suvorexant for Insomnia

Q: Will this clinical trial be studying individuals above the age of 60?

According to the eligibility requirements, patients enrolling in this clinical trial must be aged 25 to 85. There are 438 trials for people under the age of 18 and 1294 for people over 65.

Q: What is the precedent for using Suvorexant in medical trials?

There are currently 14 clinical trials involving Suvorexant, with 2 of them in Phase 3. Out of the 71 total locations, many of the studies are situated in Baltimore, <a href="https://www.withpower.com/clinical-trials/maryland">Maryland</a>.

Q: Could you give me an estimate of how many individuals will be participating in this experiment?

The listing on clinicaltrials.gov confirms that the research team is presently looking for 90 participants across 1 location(s). The study was originally posted on 8/12/2021 and was most recently edited on 8/31/2021.

Q: Are people with the specified health condition able to enroll in this trial at this time?

That is accurate. The latest information available on clinicaltrials.gov suggests that this trial is still recruiting patients. This particular study was first advertised on August 12th 2021 and has been updated as recently as August 31st 2021. They are looking for a total of 90 individuals from 1 location.

Phase 4

Waitlist Available

Led By John W Winkelman, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Awards & highlights

Study Summary

This trial will test the effects of suvorexant on sleep in patients with restless legs syndrome who still have trouble sleeping.

Eligible Conditions

Insomnia
Sleep Disorders
Restless Legs Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Actigraphically-Derived Total Sleep Time

Secondary outcome measures

Actigraphically-Derived Wake After Sleep Onset

Insomnia Severity Index

Other outcome measures

Diary-Derived Total Sleep Time

Diary-Derived Wake After Sleep Onset

Diary-derived Sleep Onset Latency, Sleep Efficiency and Sleep Quality

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment --> PlaceboExperimental Treatment2 Interventions

This group will receive suvorexant during the first 4-week phase, and placebo during the second 4-week phase.

Group II: Placebo --> TreatmentExperimental Treatment2 Interventions

This group will receive placebo during the first 4-week phase, and suvorexant during the second 4-week phase.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Suvorexant

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,932 Previous Clinical Trials

13,198,449 Total Patients Enrolled

12 Trials studying Insomnia

826 Patients Enrolled for Insomnia

Merck Sharp & Dohme LLCIndustry Sponsor

3,888 Previous Clinical Trials

5,055,037 Total Patients Enrolled

20 Trials studying Insomnia

3,512 Patients Enrolled for Insomnia

John W Winkelman, MD, PhDPrincipal InvestigatorMassachusetts General Hospital

4 Previous Clinical Trials

149 Total Patients Enrolled

Frequently Asked Questions

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

What are the potential consequences of taking Suvorexant?

"Suvorexant has completed Phase 4 trials, and thus it is approved for use."

Answered by AI

Do I meet the requirements to help with this research project?

"To take part in this clinical trial, applicants must be between 25 and 85 years old and have a current diagnosis of restless legs syndrome. Additionally, the following must be true: The applicant must be a man or woman of any ethnic origin, The applicant is willing and able to comply with study procedures, The applicant's age is 25-85 years, The applicant's International Restless Legs Syndrome Study Group scale score (IRLS) is < 15."

Answered by AI

Will this clinical trial be studying individuals above the age of 60?

"According to the eligibility requirements, patients enrolling in this clinical trial must be aged 25 to 85. There are 438 trials for people under the age of 18 and 1294 for people over 65."

Answered by AI

What is the precedent for using Suvorexant in medical trials?

"There are currently 14 clinical trials involving Suvorexant, with 2 of them in Phase 3. Out of the 71 total locations, many of the studies are situated in Baltimore, Maryland."

Answered by AI

Could you give me an estimate of how many individuals will be participating in this experiment?

"The listing on clinicaltrials.gov confirms that the research team is presently looking for 90 participants across 1 location(s). The study was originally posted on 8/12/2021 and was most recently edited on 8/31/2021."

Answered by AI

Are people with the specified health condition able to enroll in this trial at this time?

"That is accurate. The latest information available on clinicaltrials.gov suggests that this trial is still recruiting patients. This particular study was first advertised on August 12th 2021 and has been updated as recently as August 31st 2021. They are looking for a total of 90 individuals from 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia

John Winkelman, MD, PhD 2021. "Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04706091.