MOVEMENT DISORDERS RESEARCH

UNIFAI (23-1196)

• Investigator: Trevor Hawkins, MD
• Purpose: to collect data on participants to understand all the ways Friedreich Ataxia (FA) affects the participant and their body, the symptoms of FA and how those symptoms change or progress over time.
• Timeline: participant will perform a number of assessments, which can be completed in a few hours during one visit, every year. Because this study would like to capture as much information as possible about FA, the study does not currently have an end date, and your participation could be over 20 years.
• ClinicalTrials.gov Identifier: NCT06016946
• Key Eligibility Criteria:
  • Age: all ages
  • Diagnosis: Friedreich Ataxia (FA)
    

Dystonia Coalition Projects-3 (20-0290)

• Investigator: Jeanne Feuerstein, MD
• Purpose: this research includes four related projects each having different but overlapping goals: (1) learn about how dystonia may progress over time and what causes dystonia (Natural History project), (2) develop tools to measure the severity of symptoms objectively (Objective Measures project), (3) create a collection of blood samples for analysis (Biobank project), and (4) develop an app to monitor symptom severity (optional Patient-Centered Outcomes project).
• Website: https://rarediseasesnetwork.org/cms/dystonia/Get-Involved/Research-Studies/6305-Dystonia-Coalition-Projects-3-CDP3
  
• Key Eligibility Criteria:
  • Age: 18+ years old
  • Diagnosis: any isolated focal, segmental, multifocal, generalized, or hemi-dystonia
  • For optional Patient-Centered Outcomes Project: receiving Botulinum neurotoxin (BoNT) treatments as part of regular treatment plan

ELATE (22-0016) 

• Investigator: Jeanne Feuerstein, MD
• Purpose: to see if the investigational medicine is safe and helps to reduce upper limb essential tremor.
• Treatment: investigational medicine (50% chance) or placebo (50% chance).
• Timeline: 12 in-person visits over 38 weeks.
• ClinicalTrials.gov Identifier: NCT05216250
  
• Key Eligibility Criteria:
  • Age: 18-80 years old
  • Diagnosis: Essential Tremor (ET) for at least 1 year
    

Music Therapy Clinical Trial (16-2308) 

• Investigator: Isabelle Buard, PhD 
• Purpose: to learn more about the brain function related to fine motor skills in individuals with Huntington’s Disease (HD).
• Timeline: 3-4 study visits over the course of 7 weeks and 3 Neurologic Music Therapy sessions per week for 5 weeks.
• Intervention: Neurologic Music Therapy (can be done at the office of a music therapist, virtually, or in home depending on location).
• ClinicalTrials.gov Identifier: NCT03049033  
• Key Eligibility Criteria:
  • Age 30-85 years old
  • Diagnosis: Huntington’s Disease (HD)
    
  • Have some difficulties with fine motor skills (such as buttoning, cutting your food, or typing on a keyboard)
    

Brain Imaging Research Study for Multiple System Atrophy-Parkinsonian subtype (MSA-P) (22-1462)

•  Investigator: Drew Kern, MD, MS
• Purpose: to learn more about whether a new magnetic resonance imaging (MRI) method may reveal differences between patients with the Parkinsonian Type of Multiple System Atrophy (MSA-P) and patients with Parkinson’s Disease (PD).
• Assessments: clinical exam and MRI scan.
• Timeline: 1 visit at University of Colorado Hospital, about 30 minutes.
• Key Eligibility Criteria:
  • Age: 40-80 years old
  • Diagnosis: meets diagnostic criteria for probable MSA-P diagnosis, as defined by the American Academy of Neurology and National Institute of Health MSA diagnosis guidelines.
    

BIAL (23-0328)

• Investigator: Emily Forbes, DO
• Purpose: to investigate the effects, safety, and tolerability (whether side effects can be handled by a subject) of BIA 28‑6156. This study is also meant to find out if the effects, safety, and tolerability are different in people with different forms of the GBA1 gene, which is a genetic characteristic that may be related to a higher risk of getting Parkinson’s Disease (PD).
• Treatment: 
  • Part A: GBA1 and LRRK2 genetic testing.
  • Part B: study drug administration: either BIA 28‑6156, in 1 of 2 doses (10mg or 60mg), or placebo.
• Timeline: 
  • Part A: 1 in-person, 2-hour visit and 1 phone/video or in-person visit depending on genetic testing results. Total duration of Part A: ~5 weeks.
  • Part B: 9 in-person visits and 2 phone/video visits. Total duration of Part B: ~1 year and 8 months.
• ClinicalTrials.gov Identifier: NCT05819359
• Key Eligibility Criteria:
  • Age: ≥35 and ≤80 years old
  • Diagnosis: Parkinson’s Disease for at least 1 year and for no longer than 7 years before initiation of screening

BlueRock PD Diary (22-1234)

• Investigator: Alexander Baumgartner, MD
• Purpose: to study the impact of frequency of assessments on your changes and variability over time, reliability, and compliance for  a Parkinson’s disease diary, a 24-hour diary pertaining to your PD symptoms. This study is also intended to characterize the stability of your disease status, motor function, quality of life, and use of medications, without making any specific change to the treatment(s) selected by your doctor as a standard of care.
• Timeline: 7 in-person visits over 24 months.
• ClinicalTrials.gov Identifier: NCT05363046
• Key Eligibility Criteria:
  • Age: 39-70 years old
  • Diagnosis: Parkinson’s Disease for 3-18 years
  • Symptoms not adequately controlled with medications.
    

Ceregate (21-5060)

• Investigator:  Drew Kern, MD, MS 
• Purpose: to find out if CereGate therapy reduces freezing of gait in participants with Parkinson’s Disease (PD) with a pre-existing Gevia™ implanted deep brain stimulation (DBS) system..
• Treatment: your existing Gevia DBS system is programmed with an additional stimulation program for you to use when walking.  You continue to use your existing DBS program and existing medications. There are no new medications, surgeries or invasive procedures.
• Timeline: 5 in person visits over approximately 100 days.
• Key Eligibility Criteria:
  • Age: 21-75 years old
  • Diagnosis: Parkinson’s Disease (PD)
  • Currently have implanted Gevia™ DBS system
  • Currently being treated with PD medications
  • Currently have freezing of gait

ExCITES-PD (22-1685)

• Investigator: Amy Amara, MD, PhD
• Purpose: to examine the impact of exercise on sleep and cognition in Parkinson’s Disease.
• Procedures: 12-24 weeks of exercise rehabilitation, testing such as brain scans, sleep studies and questionnaires.
• Timeline: 33 total weeks in study.
• Study flyer: click here 
• Key Eligibility Criteria:
  • Parkinson’s Disease (PD):
    • Age: 45 or older
    • Diagnosis: Parkinson’s Disease
    • No contraindications to exercise
  • Study Partner:
    • Age: 18 or older
    • Spends at least 10 or more hours per week with the PD subject

Jazz PD (23-0784)

• Investigator: Jeanne Feuerstein, MD
• Purpose: to see if a test drug not yet approved for market, named suvecaltamide, will help in the treatment of moderate to severe residual tremor in people with Parkinson’s disease and how safe it is to use.
• Intervention: suvecaltamide (50% chance) or placebo (50% chance).
• Timeline: Screening Period (up to 4 weeks), Baseline Visit (up to 5 hours), Dose Titration and Optimization Period (5 weeks), Maintenance Period (12 weeks), Safety Follow-up Period (2 weeks).
• ClinicalTrials.gov Identifier: NCT05642442
• Key Eligibility Criteria:
  • Age: 40-85 years (inclusive)
  • Diagnosis: Parkinson’s Disease (PD)
  • Participants must also be on a stable dosing regimen of their permitted PD and/or other tremor medications for the treatment of motor symptoms for at least 6 weeks prior to Screening and do not anticipate the need to make any changes for the duration of the study
    

LUMA (22-0285)

• Investigator: Emily Forbes, DO
• Purpose: to look at whether the study drug (BIIB122) works in people with early-stage Parkinson’s Disease (PD), how safe it is in terms of medical problems known as “side effects”, and how the body handles taking it  (tolerability).
• Treatment: BIIB122 (50% chance) or placebo (50% chance).
• Timeline: 20 in-person visits during a period of up to 152 weeks.
• ClinicalTrials.gov Identifier: NCT05348785 
• Key Eligibility Criteria:
  • Age: 30-80 years old
  • Diagnosis: Parkinson’s Disease (diagnosis received within the past 2 years and at least 30 years old at time of diagnosis)
  • Never treated with PD medications OR treated with PD medications for less than 1 year
    

Michael J. Fox Foundation PPMI 2.0 (20-1204) 

• Investigator: Michelle Fullard, MD, MSCE  
• Purpose: to continue to obtain information from people with and without Parkinson’s disease (PD) so that researchers may better understand how PD progresses, in order to inform better treatments.
• Timeline: 2 visits annually for up to 7 years.
• ClinicalTrials.gov Identifier: NCT04477785
• Key Eligibility Criteria:
  • Age 30+ years old,
  • Diagnosis: Parkinson’s Disease (PD) for ≤ 2 years
  • NOT currently being treated with PD medications or expected to require PD medications within 6 months

Music Therapy Clinical Trial (16-2308) 

• Investigator: Isabelle Buard, PhD  
• Purpose: to learn more about the brain function related to fine motor skills in individuals with Parkinson’s disease (PD).
• Timeline: 3-4 study visits over the course of 7 weeks and 3 sessions per week for 5 weeks for either music therapy intervention, or occupational therapy (OT) intervention, or no intervention (location options available for interventions).
• Intervention: (1) musical intervention group A, (2) musical intervention group B, (3) standard of care OT, or (4) a waitlist group for 5 weeks.
• ClinicalTrials.gov Identifier: NCT03049033  
• Key Eligibility Criteria:
  • Age 45-85 years old
  • Diagnosis: Parkinson’s Disease (PD)
  • Have some difficulties with fine motor skills (such as buttoning, cutting your food, or typing on a keyboard)
    

PD GENEration: Mapping the Future of Parkinson’s Disease

•  Investigator: Jeanne Feuerstein, MD
• Purpose: a Parkinson’s Foundation initiative to help scientists advance their understanding of Parkinson’s Disease (PD) by offering genetic testing and genetic counseling at no cost for people with Parkinson’s Disease (PD).
• Assessment: one-time, home-delivered genetic testing kit.
• Study flyer: click here
• ClinicalTrials.gov Identifier: NCT04994015
• Key Eligibility Criteria:
  • Age: 18 and older
  • Diagnosis: meet Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease: probable diagnosis
    

Resistance Training Study (22-2333)

• Investigator: Mark Mañago, DPT, PhD, PT, NCS
• Purpose: this research study proposes to investigate a strengthening program using blood flow restriction to improve strength and mobility in people Parkinson Disease who have walking limitations.
• Timeline: participants must be willing and able to participate in twice weekly intervention for 8 weeks (in-person), and participate in strength and mobility assessments before and after the exercise program.
• Procedures: strength training exercises using blood flow restriction performed in-person 2x/ week under supervision of physical therapist for 8 weeks.
• Study flyer: https://www.ucdenver.edu/docs/librariesprovider61/clinical-research-pdfs/bfr-pd-ad.pdf
• Key Eligibility Criteria:
  • People with Parkinson’s Disease (PD) who have at least some difficulties with walking
  • Hoehn and Yahr Stage II or higher
    

SHINE (22-1962)

• Investigator: Trevor Hawkins, MD
• Purpose: to determine if investigational treatment, JM-010, is safe and effective in the treatment of levodopa-induced dyskinesia.
• Treatment:
  • Part 1: receive either one of 3 dose combinations of one component of JM-010 (active drug) and 1 placebo, or 2 placebos
  • Part 2: receive either one of 2 dose combinations JM-010 (active drug) and 1 placebo, one component of JM-010 and 1 placebo, or 2 placebos
• Timeline: 
  • Part 1: 5-6 in-person visits during a period of 6 to 11 weeks
  • Part 2: 7 in-person visits during a period of 15 to 20 weeks
• ClinicalTrials.gov Identifier: NCT04377945
• Key Eligibility Criteria:
  • Age: 18-85 years old
  • Diagnosis: Idiopathic Parkinson’s Disease (PD), experienced dyskinesia over a period of at least 3 months prior to Screening Visit
    

Sleep Research Study (22-1244)

•  Investigator: Jeanne Feuerstein, MD
• Purpose: to learn more about abnormal sleep in Parkinson’s and Post-Traumatic Stress Disorder (PTSD).
• Timeline: 1 in-person study visit to the Anschutz campus and 7 days of wearing a sleep and motion monitor.
• Study flyer: click here
• Key Eligibility Criteria:
  • Age: 35-80 years old
  • Diagnosis: Post-Traumatic Stress Disorder (PTSD) OR Parkinsonism
  • Diagnosis: REM sleep behavior disorder (i.e., acting out dreams in your sleep)

SPARX3 (20-1854) 

• Investigator: Cory Christiansen, PT, PhD 
• Purpose: to learn more about the effects of aerobic exercise on people with Parkinson’s Disease (PD) who have not yet started medication for their PD.
• Intervention: moderate to high intensity exercise on a treadmill
• Timeline: exercise 4x/week with periodic study visits for 24 months.
• ClinicalTrials.gov Identifier: NCT04284436 
• Key Eligibility Criteria:
  • Age 40-80 years old
  • Diagnosis: Parkinson’s Disease (PD) ≤ 3 years
  • NOT currently being treated with PD medications or expected to require PD medications within 6 months
    

Swallow Strength Study

• Investigator: Elizabeth Cuadrado, MS
• Purpose: a new study is looking at a device that would strengthen the muscles of your mouth to make eating and drinking easier for individuals with Parkinson’s Disease.
• Study flyer: https://www.ucdenver.edu/docs/librariesprovider61/clinical-research-pdfs/swallow-strenght-19-1850-cosd-flier-without-tabs-8-19-2022.pdf
• For more information, please call 303-724-8335 or email (preferred) quinlyn.axelson@cuanschutz.edu.
  

Trial of Parkinson’s and Zoledronic Acid (TOPAZ)

•  Investigator: Michelle Fullard, MD, MSCE
• Purpose: to learn if a medicine called Zoledronic Acid (ZA) can reduce fractures and deaths in people with Parkinson's Disease or parkinsonism.
• Intervention: one-time dose of the study treatment (either ZA or a placebo).
• Timeline: 1 in-person exam with a nurse at home and a study check-in (by email, mail, or phone) every 4 months to ask if you have any fractures for 2-5 years.
• Study flyer: click here
  
• ClinicalTrials.gov Identifier: NCT03924414
• Key Eligibility Criteria:
  • Age: 60 years or older
  • Diagnosis: Parkinson’s Disease (PD) or Parkinsonism
  • Have not had a hip fracture