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

Drug Has Already Been Approved

Pivotal Trial

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 below

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I have been diagnosed with Progressive Supranuclear Palsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes that requires insulin.

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I do not have any medical conditions like seizures or stroke that could explain my cognitive issues.

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I have a serious illness affecting my heart, blood, kidneys, or liver.

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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).

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.