Improving sleep in patients with Progressive Supranuclear Palsy
Treatment of Disturbed Sleep in Progressive Supranuclear Palsy (PSP)
This study is testing two sleep medications to see if they can help people with Progressive Supranuclear Palsy sleep better and feel more rested during the day.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT04014387 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of two medications, suvorexant and zolpidem, in treating sleep disturbances in individuals diagnosed with Progressive Supranuclear Palsy (PSP). Participants will undergo a double-blind, within-subject design, where they will receive each medication and a placebo over three separate one-week periods, with a washout week in between. The study aims to measure changes in sleep patterns and daytime symptoms to assess the safety and efficacy of these treatments for improving sleep quality and overall well-being in PSP patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have a confirmed diagnosis of Progressive Supranuclear Palsy.
Not a fit: Patients who do not have a diagnosis of Progressive Supranuclear Palsy or those unable to comply with study requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance sleep quality and daily functioning for patients with Progressive Supranuclear Palsy.
How similar studies have performed: Previous studies have indicated that targeting sleep disturbances in neurodegenerative conditions can yield positive outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
San Francisco, California
- University of California- San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Thomas Neylan, MD — University of California, San Francisco
- Study coordinator: Thomas Neylan, MD
- Email: Thomas.Neylan@ucsf.edu
- Phone: 415-750-6961
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.