Treatment of Disturbed Sleep in Progressive Supranuclear Palsy (PSP)

NCT ID: NCT04014387

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-02
• Study Completion Date: 2025-06-30

Brief Summary

Prior research has identified profound sleep disruption in individuals with PSP. Not only were these individuals sleeping relatively short periods at night, they were also not recuperating lost sleep during the day. Research also showed the relative preservation of a series of nuclei key in regulating wake and arousal. Investigators believe that therapeutically targeting wake promoting centers with a specific medication will improve sleep quality and overall well-being in PSP. To study this, investigators will be doing a double blind, within subject, remote clinical trial with 3 conditions: suvorexant- which targets a wake promoting system, zolpidem- a standard hypnotic that engages sleep promoting systems, versus placebo. Each condition will last 1 week and will be separated by a 1 week washout period on no sleep medications. Investigators will measure sleep patterns and daytime symptoms to determine if suvorexant, zolpidem, or both medications are safe and effective for treating sleep disturbances and improving overall well-being in PSP.

Conditions

Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Zolpidem Arm

Participants will be given one week of Zolpidem.

Group Type: ACTIVE_COMPARATOR

Zolpidem

Intervention Type: DRUG

Zolpidem (Ambien) is an FDA approved, Benzodiazepine Receptor agonist that has been extensively studied for the treatment of insomnia in older adults. It acts as a sedative and is typically prescribed to treat insomnia, reducing time to sleep onset, but may not alter the ability to maintain sleep.

Suvorexant Arm

Participants will be given one week of Suvorexant.

Group Type: ACTIVE_COMPARATOR

Suvorexant

Intervention Type: DRUG

Suvorexant (Belsomra) is an FDA approved, dual orexin receptor antagonist. It is prescribed for insomnia, reducing time to sleep onset, and to maintain nighttime sleep.

Placebo Arm

Participants will be given one week of a placebo pill.

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

Placebo (microcrystalline cellulose) capsules will be used.

Interventions

Suvorexant

Suvorexant (Belsomra) is an FDA approved, dual orexin receptor antagonist. It is prescribed for insomnia, reducing time to sleep onset, and to maintain nighttime sleep.

Intervention Type: DRUG

Zolpidem

Zolpidem (Ambien) is an FDA approved, Benzodiazepine Receptor agonist that has been extensively studied for the treatment of insomnia in older adults. It acts as a sedative and is typically prescribed to treat insomnia, reducing time to sleep onset, but may not alter the ability to maintain sleep.

Intervention Type: DRUG

Placebo oral capsule

Placebo (microcrystalline cellulose) capsules will be used.

Intervention Type: DRUG

Other Intervention Names

Belsomra; Ambien

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Neylan, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California- San Francisco

San Francisco, California, United States

Countries

United States

References

Walsh CM, Ruoff L, Walker K, Emery A, Varbel J, Karageorgiou E, Luong PN, Mance I, Heuer HW, Boxer AL, Grinberg LT, Kramer JH, Miller BL, Neylan TC. Sleepless Night and Day, the Plight of Progressive Supranuclear Palsy. Sleep. 2017 Nov 1;40(11):zsx154. doi: 10.1093/sleep/zsx154.

Reference Type: BACKGROUND

PMID: 29029214 (View on PubMed)

Other Identifiers

20181608

Identifier Type: -

Identifier Source: org_study_id