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Orexin Receptor Antagonist

Suvorexant for Insomnia

Phase 4

Recruiting

Led By Sarah Marrison, MD PhD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

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

Must have

current selective estrogen modulator or aromatase inhibitor use

Adult post menopausal breast cancer survivors (female, > 18 years old)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at baseline, 2 weeks, 4 weeks

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

"This trial will test the effectiveness of Suvorexant in improving sleep and quality of life in breast cancer survivors who are experiencing sleep problems due to their medication. Participants will be randomly assigned to either

Who is the study for?

This trial is for adult postmenopausal women who survived breast cancer, are currently on certain hormone therapies, and suffer from insomnia. They should be less than 5 years from diagnosis and finished with main cancer treatments for at least 6 weeks.

What is being tested?

The study tests if Suvorexant tablets can help improve sleep in breast cancer survivors with insomnia compared to a placebo (a pill without active medication). Participants will also receive tips on good sleep habits.

What are the potential side effects?

Suvorexant may cause drowsiness during the day, dizziness, abnormal dreams or possible worsening of depression/anxiety. It's important to report any unusual feelings or behaviors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am currently taking medication for hormone therapy.

Select...

I am a woman over 18 and a postmenopausal breast cancer survivor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at baseline, 2 weeks, 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at baseline, 2 weeks, 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, 2 weeks, 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Participant reported insomnia symptoms evaluated using the Insomnia Severity Index (ISI)

Secondary study objectives

Medication Adherence

Pain Evaluation evaluated using the Brief Pain Inventory (BPI)

Quality of Life evaluated using the Cancer Problems in Living Scale (CPIL)

+2 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Suvorexant with information on sleep hygieneExperimental Treatment1 Intervention

Participants randomized to this arm will receive 10 mg of suvorexant daily with a dose increase to 20 mg after day 7. Medication will be administered as an oral medication. Total duration of 28 days.

Group II: Placebo with information on sleep hygienePlacebo Group1 Intervention

Participants randomized to this arm will receive 10 mg of suvorexant daily with a dose increase to 20 mg after day 7. Medication will be administered as an oral medication. Total duration of 28 days.

0 / 2Eligibility criteria met