Treatment for Treatments

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University of California- San Francisco, San Francisco, CA
Treatments+1 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a medication which targets a wake promoting system may improve sleep quality for individuals with progressive supranuclear palsy.

See full description

Eligible Conditions

  • Treatments

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Treatments

Study Objectives

This trial is evaluating whether Treatment will improve 2 primary outcomes and 12 secondary outcomes in patients with Treatments. Measurement will happen over the course of 7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6).

Week 2
Medication Satisfaction
Week 2
Alertness
Cognition
Week 2
Anxiety
Clinical Global Impression
Depression
Functionality
Insomnia
Quality of Life
Quality of Life Survey
Sleepiness
Week 2
Sleep Efficiency
Week 2
Slow wave sleep
Week 2
Adverse Events

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Treatments

Trial Design

3 Treatment Groups

Zolpidem Arm
1 of 3
Suvorexant Arm
1 of 3
Placebo Arm
1 of 3
Active Control
Non-Treatment Group

This trial requires 60 total participants across 3 different treatment groups

This trial involves 3 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Placebo Arm
Drug
Participants will be given one week of a placebo pill.
Zolpidem Arm
Drug
Participants will be given one week of Zolpidem.
Suvorexant Arm
Drug
Participants will be given one week of Suvorexant.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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).
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 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). for reporting.

Closest Location

University of California- San Francisco - San Francisco, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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).
Male or female ≥18 years of age at baseline.
Have an active, co-habitation 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

Patient Q&A Section

Has treatment proven to be more effective than a placebo?

"The evidence presented suggests that a placebo does produce a clinically important effect in PPS, despite a lack of difference in the placebo arm in some studies. It may be possible that patients can be encouraged to behave in a more active and assertive manner during study sessions." - Anonymous Online Contributor

Unverified Answer

What are common treatments for supranuclear palsy, progressive?

"Surgical de-tetaneresis with corticodisplastic de-tetramerisation may be effective treatment for oculopharyngeal-esophageal dysfunction. Palliative physical therapy, surgery of neuromuscular dysfunction and orthopedic appliances including splints for patients with hip and knee stiffness may be used as adjuvant treatment for musculoskeletal dysfunction." - Anonymous Online Contributor

Unverified Answer

What causes supranuclear palsy, progressive?

"The cause of PSP is not clearly understood; genetic, infectious and environmental factors have all been implicated in the pathogenesis. The discovery of an abnormal form of the presynaptic protein SNAP-25 has opened new avenues of research into the disease and into potential drug targets." - Anonymous Online Contributor

Unverified Answer

What is supranuclear palsy, progressive?

"These studies suggest that the supranuclear pathways are involved in several cognitive and motor functions. Based on these observations, researchers are beginning to address the possibility that these pathways may be disrupted by the lesions in the brain in SPP." - Anonymous Online Contributor

Unverified Answer

What are the signs of supranuclear palsy, progressive?

"Early signs of PSP include muscle weakness, stiffness, atrophy, fasciculations, dystonia, brisk reflexes, and increased deep tendon reflexes. The facial grimace has been described as a hallmark of PSP and can be observed in the early stages of the disorder. The presence of a dysarthria with a rapid respiratory rate is another manifestation of PPS. PPS is one of the most common extrapyramidal manifestations associated with PSP. The signs of PPS include dystonia, hyperreflexia and slowed movement. The most severe form of orofacial dyskinesia in PSP causes a fixed grimace and makes the patient appear to be'masked'." - Anonymous Online Contributor

Unverified Answer

How many people get supranuclear palsy, progressive a year in the United States?

"SOPP is considered the most common cause of a motor symptoms subacute onset in children and adolescents; however, the prevalence in the general population is unknown. To the authors' knowledge, these are the first data to reveal a higher incidence of SOPP in children in the United States." - Anonymous Online Contributor

Unverified Answer

Can supranuclear palsy, progressive be cured?

"Because the natural history of SNPC is progressive, there is no cure for this degenerative movement disorder. Future research is needed to develop approaches to lessen the complications associated with neurodegenerative disorders." - Anonymous Online Contributor

Unverified Answer

How serious can supranuclear palsy, progressive be?

"While progressive supranuclear palsy can produce disabling symptoms, there is no evidence that its serious symptoms are more disabling or destructive than in classic cases." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of supranuclear palsy, progressive?

"The primary causes of progressive supranuclear palsy are unknown. The most common cause of the neurological features at onset in our patients is probably unknown and may be of peripheral neurogenic origin." - Anonymous Online Contributor

Unverified Answer

What does treatment usually treat?

"Patients with dystonia often have a variety of symptoms and need to be carefully evaluated for any specific treatment options. In addition, there are treatment options that are more global in their goals and effects. The most common treatments are discussed in the dystonia article." - Anonymous Online Contributor

Unverified Answer

What is the latest research for supranuclear palsy, progressive?

"In this review, we outlined the current research findings regarding the pathogenic mechanisms of SBPP and PSP, as well as research findings on pharmacological and neurophysiological treatment. Our review also discusses current research findings and potential research for further study of SBPP and PSP." - Anonymous Online Contributor

Unverified Answer

Is treatment typically used in combination with any other treatments?

"Treatments are commonly used in combination in spastic paraplegia treatment. In addition, the use of a specific treatment in combination with any other treatments is more common as symptom severity and functional disability deteriorate." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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