Open Label Extension Study for Parkinson Disease

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Kansas Medical Center - Parkinson's Disease Center, Kansas City, KS
+2 More
Open Label Extension Study - Device
Eligibility
18+
All Sexes
Eligible conditions
Parkinson Disease

Study Summary

STEM-PD Open Label Extension (OLE)

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Eligible Conditions

  • Parkinson Disease
  • Parkinsonian Disorders
  • Parkinson's Disease and Parkinsonism

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Open Label Extension Study will improve 2 primary outcomes, 4 secondary outcomes, and 20 other outcomes in patients with Parkinson Disease. Measurement will happen over the course of 3 months.

3 months
MDS-NMS Assessment
8 months
Change from baseline in EncephaLogTM 10m Timed Up and Go (10m TUG)
Change from baseline in EncephaLogTM 3 meter Timed Up and Go Test
Change from baseline in EncephaLogTM finger tapping test
Change from baseline in Epworth Sleepiness Scale
Change from baseline in Hoehn & Yahr (H&Y)
Change from baseline in Patient Global Impression of Improvement
Change from baseline in The International Parkinson and Movement Disorder Society - Non-Motor Rating Scale (MDS-NMS) Total Score
Change from baseline in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II
Change from baseline in The Modified Schwab and England Activities of Daily Living Scale
Change from baseline in Unified Parkinson's disease Rating Scale Part I (UPDRS I)
Change from baseline in a Non-Motor Symptom focused Clinical Global Impression-Improvement
Change from baseline in the Clinical Global Impression - Improvement (CGI-I)
Change from baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue Scale
Change from baseline in the Geriatric Depression Scale-15
Change from baseline in the MDS-NMS Non-Motor Fluctuations
Change from baseline in the MDS-UPDRS Part III
Change from baseline in the Mini-Balance Evaluation Systems Test
Change from baseline in the Montreal Cognitive Assessment
Change from baseline in the Oral Symbol Digit Modality Test
Change from baseline in the Parkinson Anxiety Scale
Change from baseline in the Parkinson's Disease Quality of Life Questionnaire Summary Index (PDQ-39 SI)
Change from baseline in the Parkinson's Disease Sleep Scale
Change from baseline in the Patient Reported Outcome - Parkinson's Disease
Change from baseline in the Unified Parkinson's Disease Rating Scale Part IV
Change from baseline in the Zarit Burden Interview

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Experimental Treatment 1

This trial requires 220 total participants across 2 different treatment groups

This trial involves 2 different treatments. Open Label Extension Study is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Treatment 1
Device
Study participants will self-administer ~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 8 months for reporting.

Closest Location

University of Kansas Medical Center - Parkinson's Disease Center - Kansas City, KS

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Completion of the study activities in the STEM-PD RCT trial. l.
Participants must be willing and able to give consent to participate in the study trial.

Patient Q&A Section

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

What causes parkinson disease?

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There is controversy over the cause of Parkinson's disease, with a number of theories including both genetic and environmental factors. This is also true for the cause of the autonomic disorder, with both genetic and environmental causes being identified. Understanding these causes may aid in the creation of better treatments and a better understanding of the underlying mechanisms, with the ultimate goal of achieving better outcomes for patients with these disabling disorders.

Unverified Answer

What are common treatments for parkinson disease?

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Despite advances in therapies and therapy for PD, people with PD continue to have a decline in quality of life. Treatment is frequently targeted toward treating PD symptoms but does not necessarily treat associated comorbidities or mental health problems.

Unverified Answer

How many people get parkinson disease a year in the United States?

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In the United States around 1.3 million people are diagnosed annually with Parkinson's disease, an estimate that does not incorporate the possibility of underreporting. However, the actual prevalence of the disease is unknown as is the prevalence of the disease before the age of 65 years.

Unverified Answer

Can parkinson disease be cured?

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There is no convincing evidence that Parkinson's disease can be cured. However, some patients can have a long and meaningful lifetime after adjusting medication and exercise, with or without physical therapy.

Unverified Answer

What are the signs of parkinson disease?

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Symptoms for both diseases are similar and include problems with walking, postural imbalance, tremors, and swallowing problems and may be indicative of Parkinson's disease (PD).

Unverified Answer

What is parkinson disease?

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PD, a condition characterized by death of dopaminergic neurons in the substantia nigra of the brain, causes a decline in motor function, including tremors and slowness for movement. In the most advanced stage of the disease, paralysis may develop in a specific pattern, known as akinesia. It can also cause stiffness and difficulty walking, called dyskinesia.\n

Unverified Answer

Does open label extension study improve quality of life for those with parkinson disease?

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Oral ropinirole was well tolerated over a treatment period of 12 months. We found meaningful improvements in certain aspects of patient-reported PD-Quality of Life including better satisfaction with speech, social activities, physical comfort, personal autonomy, and bodily functions or sensations.

Unverified Answer

Is open label extension study safe for people?

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Oral CBD at 25 and 2000 mg for up to 2 years was generally well-tolerated and a positive impact on URR and QoL was noted.

Unverified Answer

What is the latest research for parkinson disease?

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Parkinsons is an age-related disease that occurs when dopamine production decreases in the region of the forebrain called the substantia nigra. The exact causes and the mechanism of Parkinsons is still not fully understood. This is why there are multiple research that is currently being conducted. Some of the most notable recent research include:

  1. Neural Repair and Replacement Cells\n2. Neuroprotective/Neuroreparative Agents\n3. Neuroprotective/Reparative agents in Parkinson's Disease\n4. New and Improved Dopamine Replacement Treatments\n5.
Unverified Answer

How serious can parkinson disease be?

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PD is the most common movement disorder, but its symptoms vary greatly among patients. The disease may affect one's mobility, mobility, posture, speech or cognitive function. The disease is classified into a number of subtypes, each of which responds differently to treatment. PD is a lifelong disease, with symptoms typically growing worse over time. PD occurs when dopamine-producing nerves in the brain and other body parts die, leading to problems controlling muscles, nerves and other body functions. Because drugs that help manage PD are often used to treat a number of other conditions, it can be a difficult disease to diagnose. You can find ongoing clinical trials for PD at [Power]( http://www.withpower.

Unverified Answer

What does open label extension study usually treat?

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In a subset of the most common PD-L1-expressing PD, most probably based on antibody responses to a panel of PD antigenic targets, the efficacy of the checkpoint inhibitor nivolumab was comparable to that of standard of care chemotherapy. Results are consistent with durable PFS benefits even in the longest extension cohorts.

Unverified Answer

What is open label extension study?

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Results from a recent paper support the use of PDE5I therapy for patients with a strong family history of Parkinson disease-predominant Lewy body dementia. The data indicate that treatment with PDE5I therapy has potential therapeutic benefit for these patients. If no new neurologic syndromes develop, PDE5I may be used successfully for an additional period up to five years. The study is ongoing, but no new neurologic syndromes have been reported up to September 2010.

Unverified Answer
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