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Treatment of Disturbed Sleep in Progressive Supranuclear Palsy (PSP)
Lead sponsor
Assets
Suvorexant / Zolpidem
Listed sites
1
Recruiting sites
-
Enrollment
40
actual
Study population
Frontotemporal dementia
Key I/E criterion
•Study partner/caregiver required
Primary endpoints
•Sleep Efficiency•Clinical Global Impression
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (13)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Memory
1 endpointCognition
Time frame:7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1)
change from baseline, improvement
Executive function / language
1 endpointFunctionality
Time frame:7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1).
change from baseline, improvement
Behavior / neuropsychiatric
5 endpointsSleep Efficiency
Time frame:average each of the 7 nights of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1).
change from baseline, improvement
Alertness
Time frame:7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1)
change from baseline, improvement
Anxiety
Time frame:7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1).
change from baseline, improvement
Depression
Time frame:7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1).
change from baseline, improvement
Slow wave sleep
Time frame: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).
change from baseline, improvement
Caregiver / quality of life
2 endpointsClinical Global Impression
Time frame:7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1).
change from baseline, improvement
Quality of Life Survey
Time frame:7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1).
change from baseline, improvement
Safety / tolerability / PK
1 endpointAdverse Events
Time frame:total of events across the 7 days/nights of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1).
event count, event
Other (unclassified)
3 endpointsMedication Satisfaction
Time frame:7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6)
descriptive
Sleepiness
Time frame:7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1).
change from baseline, improvement
Insomnia
Time frame:7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1).
change from baseline, improvement
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- PMID29029214via BACKGROUND
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.