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Suvorexant for Sleep Disturbances in PSP

Phase 4
Recruiting
Led By Thomas Neylan, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be free of sleep modifying medications for 1 week prior to actively starting the study
Male or female ≥18 years of age at baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up average of 5th-7th night of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1).
Awards & highlights

Study Summary

This trial is testing whether a new medication, suvorexant, can improve sleep quality and overall well-being in PSP by targeting wake promoting centers.

Who is the study for?
This trial is for adults with Progressive Supranuclear Palsy (PSP) who have stable medications, a caregiver, and can comply with study requirements. Participants must not be on sleep-modifying meds prior to the study or have conditions that could affect safety/data quality.Check my eligibility
What is being tested?
The trial tests if suvorexant or zolpidem improves sleep in PSP compared to a placebo. It's a double-blind study where each treatment lasts one week with washout periods in between. Sleep patterns and daytime symptoms are measured to assess effectiveness.See study design
What are the potential side effects?
Potential side effects of suvorexant may include drowsiness, headache, dizziness, and abnormal dreams. Zolpidem might cause daytime drowsiness, weakness, feelings of being drugged or light-headedness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't taken any sleep medications for the last week.
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I am 18 years old or older.
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I have been diagnosed with Progressive Supranuclear Palsy.
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My medications, except for those affecting sleep, have been stable for 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~average of 5th-7th night of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1).
This trial's timeline: 3 weeks for screening, Varies for treatment, and average of 5th-7th night of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Global Impression
Sleep Efficiency
Secondary outcome measures
Adverse Events
Alertness
Anxiety
+8 more

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Zolpidem ArmActive Control1 Intervention
Participants will be given one week of Zolpidem.
Group II: Suvorexant ArmActive Control1 Intervention
Participants will be given one week of Suvorexant.
Group III: Placebo ArmPlacebo Group1 Intervention
Participants will be given one week of a placebo pill.

Find a Location

Who is running the clinical trial?

US Department of Veterans AffairsFED
867 Previous Clinical Trials
487,790 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,496 Previous Clinical Trials
11,933,789 Total Patients Enrolled
Thomas Neylan, MDPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Suvorexant (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04014387 — Phase 4
Treatment Research Study Groups: Zolpidem Arm, Suvorexant Arm, Placebo Arm
Treatment Clinical Trial 2023: Suvorexant Highlights & Side Effects. Trial Name: NCT04014387 — Phase 4
Suvorexant (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04014387 — Phase 4

Frequently Asked Questions

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

What are the fundamental aims of this trial?

"This clinical trial's primary goal is to assess Clinical Global Impression of the two hypnotic drugs and placebo administered over 7 nights (weeks 2, 4 and 6) in comparison with baseline scores from week 1. Secondary outcomes include Cognition which will be measured by working memory tasks such as digits forward/backwards; executive function evaluations such as categorical fluency & verbal fluency; plus any rule violations or repetitions that occur during testing. Functionality will be assessed via Tau Functional Scale - a questionnaire completed together by patient & caregiver assessing motor experiences, language/cogntive behavioural concerns, other non-motor daily"

Answered by AI

Are there any vacancies left to participate in this research?

"Per the information provided by clinicaltrials.gov, this trial is actively enlisting patients for participation. It was initially posted on June 2nd 2019 and has been amended most recently on April 25th 2022."

Answered by AI

Are there any precedents of research involving Zolpidem Arm?

"Currently, 18 trials are in progress for Zolpidem Arm with 2 of these reaching Phase 3. Most of the tests taking place involve patients from Silver Spring, Maryland but there is also a total number of 83 different clinical sites conducting research on this drug."

Answered by AI

How many participants are actively participating in the research endeavor?

"Affirmative. Evidence on clinicaltrials.gov indicates that this experiment is actively looking for participants, having been posted to the website in June 2019 and updated as recently as April 2022. The research team needs 60 people at a single facility to participate."

Answered by AI

Has the FDA sanctioned Zolpidem Arm for use?

"Zolpidem Arm has been approved for use in clinical treatments and thus is allotted a score of 3, reflecting its relative safety."

Answered by AI
~2 spots leftby Jun 2024