Can a sleep drug help people with PSP rest better?
NCT ID NCT04014387
First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times
Summary
This study tested two sleep medications (suvorexant and zolpidem) against a placebo in 40 adults with Progressive Supranuclear Palsy (PSP). The goal was to see if targeting the brain's wake-promoting system could improve sleep quality and daytime well-being. Each person tried all three treatments for one week each, with a week off in between. The study measured sleep patterns and overall health to find a safe and effective option for better rest.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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40 people
The number who actually took part.
- Started
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Jun 2019
- Finished
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Jun 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Male or female ≥18 years of age at baseline. 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. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. Have a diagnosis of PSP verified through co-enrollment in ARTFL, LEFFTDS or 4RTNI, or can show evidence of an accurate diagnosis of PSP to the satisfaction of the study team doctor (e.g. through review of medical records, and/or specific communication with a known medical doctor). Have an active caregiver who is willing and able to participate in this study Have a mailing address Have access to a phone Have stable medications (aside from sleep-modifying medications) for 4 weeks prior to actively starting the study Be free of sleep modifying medications for 1 week prior to actively starting the study Be willing to maintain a stable sleeping environment and their typical daily schedule for the duration of the 6-week study Resides in a US territory or state covered by our research study team. Exclusion Criteria: Are pregnant, breastfeeding, or unwilling to practice birth control if appropriate during participation in the study. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. Presence of a major psychiatric disorder aside from anxiety or depression. Presence of a medical condition other than PSP that could account for cognitive deficits (e.g. active seizure disorder, stroke, vascular dementia). Presence of current substance abuse or substance dependence. Presence of a significant systemic medical illness (e.g. significant cardiovascular, hematologic, renal, or hepatic disease). Presence of current medication likely to affect sleep outcomes: benzodiazepine receptor agonists (e.g. Zolpidem), Suvorexant, sedating antipsychotics (e.g. Quetiapine), sedating antihistamines (e.g. Benadryl), low dose sedating antidepressants (e.g. Trazodone, Doxepin), over the counter sleep-inducing medications (e.g. Tylenol-PM), neuroleptics in the phenothiazine and haloperidol families) which 1) the potential participant is not able/willing to stop taking for 1- week prior and for the 6-week duration of the study and/or 2) if removed could have a persistent effect beyond the 1-week wash-out period. Presence of insulin-dependent diabetes. History of mental retardation. Unable to communicate in English.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of California- San Francisco
San Francisco, California, 94158, United States
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