- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04014387
Treatment of Disturbed Sleep in Progressive Supranuclear Palsy (PSP)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Thomas Neylan, MD
- Phone Number: 415-750-6961
- Email: Thomas.Neylan@ucsf.edu
Study Contact Backup
- Name: Christine Walsh, PhD
- Email: Christine.Walsh@ucsf.edu
Study Locations
-
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California
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San Francisco, California, United States, 94158
- Recruiting
- University of California- San Francisco
-
Contact:
- Christine Walsh, PhD
- Email: Christine.Walsh@ucsf.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Zolpidem Arm
Participants will be given one week of 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.
Other Names:
|
Active Comparator: Suvorexant Arm
Participants will be given one week of 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.
Other Names:
|
Placebo Comparator: Placebo Arm
Participants will be given one week of a placebo pill.
|
Placebo (microcrystalline cellulose) capsules will be used.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep 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 in sleep efficiency (as measured by actigraphy), this is a percentage of the time spent asleep compared to the total time in bed.
The range of scores is 0-100, with higher scores associated with better sleep efficiency.
|
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).
|
Clinical 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 in Clinical Global Impression (CGI-C), this is a series of questions for the participant and caregiver which the neurologist utilizes to give a score of disease affects across a series of domains, which produces a single change score referenced to the baseline Clinical Global Impression of Disease Severity (CGI-ds).
The range of scores is 1-7, with lower scores associated with better health.
|
7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication Satisfaction
Time Frame: 7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6)
|
Differences in satisfaction with the medication being taken.
The Medication Satisfaction Scale is a study-specific customized satisfaction questionnaire of 3 questions each with a 5-point likert scale.
The total range of scores is 3-15, with higher scores associated with greater medication satisfaction.
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7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6)
|
Adverse 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).
|
The difference in the number of adverse events across each assessment week.
The range of scores is 0 - undetermined, with greater scores associated with greater adverse events.
|
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).
|
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 in alertness, which is assessed using question 8 of the Mayo Sleep Questionnaire - Informant.
The range of scores is 0-10 with higher scores associated with greater alertness.
|
7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1)
|
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 in sleepiness, which is assessed using the Epworth Sleepiness Scale.
The range of scores is 0-24 with higher scores associated with increased sleepiness.
|
7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1).
|
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 in subjectively reported insomnia assessed using the Insomnia Severity Index.
The range of scores is 0-28 with higher scores associated with increased levels of insomnia.
|
7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1).
|
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 in anxiety levels assessed using the Generalized Anxiety Disorder - 7 (GAD-7) scale.
The range of scores is 0-21 with higher scores associated with greater anxiety.
|
7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1).
|
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 in depression assessed using the PHQ-9 scale.
The range of scores is 0-27 with higher scores associated with greater depression.
|
7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1).
|
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 in quality of life using the PSP Quality of life survey (PSP-QoL) , which assesses subjective quality of life specifically in individuals with Progressive Supranuclear Palsy.
The range of scores is 0-100 with higher scores associated with poorer quality of life.
|
7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1).
|
Functionality
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 in functionality is assessed using the Tau functional scale.
This is a questionnaire, which both the patient and caregiver work together to complete.
The total range of scores is 0-124 with subscores for "motor experiences of daily living" (0-48 points), "Language/cognitive/behavioral" concerns (0-52) and "Other non-motor experiences of daily living" (0-24).
In all cases, greater scores are associated with decreased independent functionality in those domains.
|
7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1).
|
Cognition
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 in cognition will be assessed using working memory measures of digits forward and digits backward, and executive function measures of categorical fluency and verbal fluency.
The range of scores for digits forward and digits backward is 0-16 each, with higher scores indicating better cognition.
The likely range of scores for the fluency measures are 0-60 with higher scores associated with better executive function.
Rule violations and repetitions are also counted and scored with greater scores in these domains associated with poorer cognition.
|
7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1)
|
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 in slow wave sleep will be assessed using a mobile EEG monitor called the Sleep Profiler (Advanced Brain Monitoring, Inc.).
The amount of slow wave sleep will be measured as a percent of total sleep time, so the range of scores will be 0-100, with higher scores associated with greater amounts of slow wave sleep.
|
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).
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Thomas Neylan, MD, University of California, San Francisco
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Eye Diseases
- Neurologic Manifestations
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Tauopathies
- Cranial Nerve Diseases
- Ocular Motility Disorders
- Paralysis
- Ophthalmoplegia
- Supranuclear Palsy, Progressive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Hypnotics and Sedatives
- GABA Agents
- Sleep Aids, Pharmaceutical
- Orexin Receptor Antagonists
- GABA-A Receptor Agonists
- GABA Agonists
- Suvorexant
- Zolpidem
Other Study ID Numbers
- 20181608
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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