Suvorexant for Sleep Disturbances in PSP

Recruiting in Palo Alto (17 mi)

Overseen by Thomas Neylan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of California, San Francisco

Must not be taking: Benzodiazepines, Sedating antipsychotics

Disqualifiers: Pregnancy, Major psychiatric disorder, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications to join the trial?

You need to stop taking sleep-modifying medications for 1 week before starting the study and cannot take them during the 6-week study. Other medications must be stable for 4 weeks before starting the study.

What data supports the idea that the drug Suvorexant for Sleep Disturbances in PSP is an effective treatment?

The available research does not provide any data on Suvorexant for Sleep Disturbances in PSP. The articles focus on other conditions and treatments, such as sleep-disordered breathing and prostate cancer therapies, but do not mention Suvorexant or its effectiveness for sleep disturbances in PSP. ^{1 2 3 4 5}

What safety data exists for Suvorexant for sleep disturbances in PSP?

The provided research does not contain any safety data for Suvorexant or its other names (Belsomra, MK-4305, MK4305, Zolpidem, Ambien) related to sleep disturbances in PSP. The studies focus on bisphosphonates like zoledronic acid and their effects in multiple myeloma and other conditions, which are unrelated to Suvorexant. ^{6 7 8 9 10}

Is the drug Suvorexant a promising treatment for sleep disturbances in PSP?

Yes, Suvorexant is a promising drug for sleep disturbances because it helps people fall asleep faster and stay asleep longer. It is approved by the FDA for treating insomnia and has shown positive effects on sleep quality in various studies. ^{11 12 13 14 15}

Research Team

Thomas Neylan, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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.

Inclusion Criteria

You have been diagnosed with PSP by participating in certain research studies or by providing evidence of an accurate diagnosis to the study doctor.

Be willing to maintain a stable sleeping environment and their typical daily schedule for the duration of the 6-week study

I haven't taken any sleep medications for the last week.

Exclusion Criteria

I am not taking sleep-affecting medications or can stop them for 7 weeks.

I have diabetes that requires insulin.

You have a history of intellectual disability.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a double-blind, within-subject trial with three conditions: suvorexant, zolpidem, and placebo, each lasting 1 week, separated by a 1-week washout period.

6 weeks

Remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo oral capsule (Other)
• Suvorexant (Other)
• Zolpidem (Other)

Trial Overview 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.

Participant Groups

Group I: Zolpidem Arm Active Control 1 Intervention

Participants will be given one week of Zolpidem.

Group II: Suvorexant Arm Active Control 1 Intervention

Participants will be given one week of Suvorexant.

Group III: Placebo Arm Placebo Group 1 Intervention

Participants will be given one week of a placebo pill.

Suvorexant is already approved in Japan for the following indications:

Approved in Japan as Belsomra for:

• Insomnia characterized by difficulties with sleep onset and/or sleep maintenance

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of California- San Francisco San Francisco, CA

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2636

Patients Recruited

19,080,000+

US Department of Veterans Affairs

Collaborator

Trials

881

Patients Recruited

502,000+

Findings from Research

Positive airway pressure (PAP) therapy is the gold standard for treating sleep-disordered breathing, significantly reducing apnea-hypopnea index (AHI) and improving patient quality of life, but many patients struggle with adherence due to discomfort.

Emerging treatments like the hypoglossal nerve stimulator and phrenic nerve stimulator offer promising alternatives by directly stimulating nerves to alleviate airflow obstruction and stabilize breathing patterns, respectively, thus improving AHI severity and quality of life for patients with obstructive and central sleep apnea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in Treatment of Sleep-Disordered Breathing. Lou, BX., Greenberg, H., Korotun, M.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapy Update for Metastatic Castration-Resistant Prostate Cancer. Dinh, JA., Baker, D., Chahal, M.[2017]

In a Phase I trial of suramin for hormone-refractory prostate cancer, 22% of patients on low doses and 32% on high doses experienced adrenal cortical insufficiency, indicating a dose-dependent risk of glucocorticoid and mineralocorticoid insufficiency.

Long-term glucocorticoid insufficiency was observed in 20% of patients tested more than 90 days after stopping suramin, suggesting that patients on high doses should receive appropriate hormone replacement therapy to manage potential adrenal insufficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mineralocorticoid insufficiency due to suramin therapy. Kobayashi, K., Weiss, RE., Vogelzang, NJ., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety exposure-response relationships of apalutamide in patients with metastatic castration-sensitive prostate cancer: results from the phase 3 TITAN study. T'jollyn, H., Ackaert, O., Chien, C., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison of Abiraterone Acetate Plus Prednisolone and Combined Androgen Blockade in High-risk Metastatic Hormone-Sensitive Prostate Cancer]. Yasukawa, H., Ikehata, Y., Tsuboi, Y., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteonecrosis of the jaw and renal safety in patients with newly diagnosed multiple myeloma: Medical Research Council Myeloma IX Study results. Jackson, GH., Morgan, GJ., Davies, FE., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of zoledronic acid in multiple myeloma patients undergoing high-dose chemotherapy and stem-cell transplantation. Avilés, A., Neri, N., Huerta-Guzmán, J., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Possible survival benefits from zoledronic acid treatment in patients with bone metastases from solid tumours and poor prognostic features-An exploratory analysis of placebo-controlled trials. Coleman, RE., Lipton, A., Costa, L., et al.[2022]

In a study of 1,655 multiple myeloma patients, those treated with zoledronic acid (ZOL) experienced significantly lower rates of skeletal-related events (SREs) and mortality compared to those who did not receive bisphosphonate therapy.

Patients who maintained longer treatment persistency with ZOL (≥1.5 years) had a much lower incidence of SREs and fractures, highlighting the importance of consistent treatment for maximizing clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persistency with zoledronic acid is associated with clinical benefit in patients with multiple myeloma. Henk, HJ., Teitelbaum, A., Perez, JR., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I and pharmacologic study of estramustine phosphate and short infusions of paclitaxel in women with solid tumors. Garcia, AA., Keren-Rosenberg, S., Parimoo, D., et al.[2017]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a randomised controlled trial evaluating the effects of the orexin receptor antagonist suvorexant on sleep architecture and delirium in the intensive care unit. Azimaraghi, O., Hammer, M., Santer, P., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of suvorexant, an orexin receptor antagonist, on sleep parameters as measured by polysomnography in healthy men. Sun, H., Kennedy, WP., Wilbraham, D., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suvorexant for the treatment of insomnia. Jacobson, LH., Callander, GE., Hoyer, D.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of Suvorexant in Urine Using Liquid Chromatography-Quadrupole/Time-of-Flight Mass Spectrometry (LC-Q/TOF-MS). Sullinger, S., Bryand, K., Kerrigan, S.[2017]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro and in vivo characterisation of the metabolism and disposition of suvorexant in humans. Cui, D., Cabalu, T., Yee, KL., et al.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Advances in Treatment of Sleep-Disordered Breathing. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Therapy Update for Metastatic Castration-Resistant Prostate Cancer. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Mineralocorticoid insufficiency due to suramin therapy. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and safety exposure-response relationships of apalutamide in patients with metastatic castration-sensitive prostate cancer: results from the phase 3 TITAN study. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

[Comparison of Abiraterone Acetate Plus Prednisolone and Combined Androgen Blockade in High-risk Metastatic Hormone-Sensitive Prostate Cancer]. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Osteonecrosis of the jaw and renal safety in patients with newly diagnosed multiple myeloma: Medical Research Council Myeloma IX Study results. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of zoledronic acid in multiple myeloma patients undergoing high-dose chemotherapy and stem-cell transplantation. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Possible survival benefits from zoledronic acid treatment in patients with bone metastases from solid tumours and poor prognostic features-An exploratory analysis of placebo-controlled trials. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Persistency with zoledronic acid is associated with clinical benefit in patients with multiple myeloma. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Phase I and pharmacologic study of estramustine phosphate and short infusions of paclitaxel in women with solid tumors. [2017]

11. England pubmed.ncbi.nlm.nih.gov

Study protocol for a randomised controlled trial evaluating the effects of the orexin receptor antagonist suvorexant on sleep architecture and delirium in the intensive care unit. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Effects of suvorexant, an orexin receptor antagonist, on sleep parameters as measured by polysomnography in healthy men. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Suvorexant for the treatment of insomnia. [2015]

14. England pubmed.ncbi.nlm.nih.gov

Identification of Suvorexant in Urine Using Liquid Chromatography-Quadrupole/Time-of-Flight Mass Spectrometry (LC-Q/TOF-MS). [2017]

15. England pubmed.ncbi.nlm.nih.gov

In vitro and in vivo characterisation of the metabolism and disposition of suvorexant in humans. [2017]