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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
Documentation of a Progressive Supranuclear Palsy diagnosis as evidenced by one or more clinical features consistent with the Progressive Supranuclear Palsy phenotype as described in the Movement Disorder Society criteria or the NINDS-SPSP criteria
Be older than 18 years old
Must not have
Presence of insulin-dependent diabetes
Presence of a medical condition other than PSP that could account for cognitive deficits (e.g. active seizure disorder, stroke, vascular dementia)
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
Summary
This trial tests two medications, suvorexant and zolpidem, on people with PSP who have severe sleep issues. Suvorexant helps block wakefulness signals to improve sleep, while zolpidem boosts sleep signals to help people fall asleep. The study aims to see if these medications can safely improve sleep and well-being.
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.
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.
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 belowSelect...
I have been diagnosed with Progressive Supranuclear Palsy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have diabetes that requires insulin.
Select...
I do not have any medical conditions like seizures or stroke that could explain my cognitive issues.
Select...
I have a serious illness affecting my heart, blood, kidneys, or liver.
Select...
I cannot communicate in English.
Timeline
Screening ~ 3 weeks3 visits
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).
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).
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical Global Impression
Sleep Efficiency
Secondary study objectives
Adverse Events
Alertness
Anxiety
+8 moreTrial 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
872 Previous Clinical Trials
497,929 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,551 Previous Clinical Trials
15,257,826 Total Patients Enrolled
Thomas Neylan, MDPrincipal InvestigatorUniversity of California, San Francisco
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Zolpidem Arm
- Group 2: Suvorexant Arm
- Group 3: Placebo Arm
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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.
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