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Suvorexant for Sleep Disturbances in PSP
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- You have been diagnosed with PSP by participating in certain research studies or by providing evidence of an accurate diagnosis to the study doctor.I haven't taken any sleep medications for the last week.I am 18 years old or older.I am not taking sleep-affecting medications or can stop them for 7 weeks.I have diabetes that requires insulin.I have been diagnosed with Progressive Supranuclear Palsy.My medications, except for those affecting sleep, have been stable for 4 weeks.You have a history of intellectual disability.I do not have any medical conditions like seizures or stroke that could explain my cognitive issues.I have a serious illness affecting my heart, blood, kidneys, or liver.I cannot communicate in English.You currently have a problem with using drugs or alcohol.You have a serious mental health condition other than anxiety or depression.
- Group 1: Zolpidem Arm
- Group 2: Suvorexant Arm
- Group 3: Placebo Arm
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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"
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."
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."
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."
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."
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