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Trial record 1 of 2 for:    BlueRock Therapeutics | Parkinson Disease
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Noninterventional Study Evaluating Parkinson's Disease Diary Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05363046
Recruitment Status : Recruiting
First Posted : May 5, 2022
Last Update Posted : October 6, 2022
Information provided by (Responsible Party):
BlueRock Therapeutics

Brief Summary:
This study aims to evaluate the impact of the frequency of assessments on the variability over time, reliability, and compliance for the Parkinson's disease (PD) diary in patients with PD in whom medications do not provide adequate control of symptoms.

Condition or disease
Parkinson's Disease

Detailed Description:
This is a global, multi-center, noninterventional study of patients with PD aged ≥39 to ≤70 years under standard-of-care treatment that will enroll approximately up to 500 participants. Participants will be assigned (1:1) to complete the PD diary either on 3 consecutive days in 1 week (Group A) or 2 consecutive days in each of 2 consecutive weeks (Group B) for a given study visit. During the study, data are collected on motor function, quality of life, and use of PD medications at Baseline and at 3, 6, 12, 18, and 24 months.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-center, Noninterventional Study Evaluating Variability, Reliability, and Compliance for the Parkinson's Disease Diary
Actual Study Start Date : July 29, 2022
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2026

Resource links provided by the National Library of Medicine

Group A
Participants will complete the PD diary on 3 consecutive days in 1 week.
Group B
Participants will complete the PD diary on 2 consecutive days in each of 2 consecutive weeks.

Primary Outcome Measures :
  1. Change in Good ON-time as measured by the PD Diary. [ Time Frame: Baseline, 3, 6, 12, 18 and 24 months. ]
    Standard deviation of change in ON-time without troublesome dyskinesia (Good ON-time) as measured by the PD diary.

  2. Individual participant variability for ON-time without troublesome dyskinesia (Good ON-time) as measured by the PD diary. [ Time Frame: Baseline, 3, 6, 12, 18 and 24 months. ]
    Within-subject coefficient of variation for ON-time without troublesome dyskinesia (Good ON-time) as measured by the PD diary.

  3. Proportion of valid PD Diaries. [ Time Frame: Baseline, 3, 6, 12, 18 and 24 months. ]
    Proportion of valid PD Diaries.

Information from the National Library of Medicine

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Ages Eligible for Study:   39 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Parkinson's disease patients whose medications do not provide adequate control of their symptoms.

Inclusion Criteria

  • ≥39 to ≤70 years of age at signing of informed consent
  • Diagnosis of clinically established PD as defined by the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for PD
  • Marked levodopa responsiveness at screening per investigator's judgment (eg, an estimated ≥30% improvement of MDS-UPDRS Part III score in the off-medication versus on-medication state)
  • A minimum of 3 years and a maximum of 18 years from time of PD diagnosis to the date of screening
  • Receiving optimized and stable PD medical therapy for ≥1 month prior to screening or demonstrated intolerance to PD medications per investigator's judgment in agreement with the medical monitor
  • ≥3 hours of average daily OFF-time assessed within 3 months of screening by PD diary or per investigator's judgment
  • Hoehn and Yahr Stage of 1 to 3 while on PD medication assessed within 3 months of screening or at screening
  • Normal cognition as determined by the investigator after review of relevant testing (eg, Montreal Cognitive Assessment score of ≥26, or ≥22 if no significant cognitive impairment as determined by neuropsychological testing)

Exclusion Criteria:

  • PD with risk of recurrent falls or only tremor-based symptoms
  • Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis, or clinical features suggestive of a neurodegenerative disease other than PD such as Alzheimer's disease
  • Any available evidence inconsistent with dopamine deficiency (eg, 18F-DOPA positron emission tomography [PET] or dopamine transporter single-photon emission computed tomography [DAT-SPECT] imaging if performed)
  • Moderately severe dyskinesia per investigator's judgment
  • Receiving dopamine receptor-blocking agents, including typical neuroleptics, prochlorperazine, and metoclopramide at the time of screening or within 3 months prior to screening
  • Treatment with intrajejunal or subcutaneous infusion therapies for PD within 2 months of screening
  • History of PD therapy with deep brain stimulation, lesion therapy, gene therapy, or cell therapy
  • Prior surgical or radiation therapy to the brain or spinal cord
  • Receipt of another investigational therapy or device within 2 years of screening unless approved by the medical monitor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05363046

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Contact: Marta E Farino-Silva 1-617-930-9292 clinicaltrials@bluerocktx.com

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United States, Arizona
Mayo Clinic Neurology Not yet recruiting
Scottsdale, Arizona, United States, 85259
Contact    480-342-2906      
United States, California
David Geffen School of Medicine University of California Los Angeles Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Diane Yang    310-206-3356    ddyang@mednet.ucla.edu   
University of California, Irvine Not yet recruiting
Orange, California, United States, 92868
Contact: Alpha Stem Cell Clinic    949-824-3990    stemcell@uci.edu   
United States, Colorado
University of Colorado Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Karrie Hardin    303-724-4644    karrie.hardin@cuanschutz.edu   
United States, Florida
Movement Disorders Center of Boca Raton Recruiting
Boca Raton, Florida, United States, 33486
Contact: Cassandra War    561-392-1818 ext 2    cwar@parkinsonscenter.org   
University of Miami Health System Not yet recruiting
Miami, Florida, United States, 33136
Contact: Ihtsham Ul Haq, MD    305-243-2172    ihaq@med.miami.edu   
United States, Illinois
Parkinson's Disease and Movement Disorders Center at Northwestern University Feinberg School of Medicine Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Cynthia Poon, PhD    312-503-8216    cynthia.poon@northwestern.edu   
United States, Kansas
University of Kansas Medical Center Not yet recruiting
Kansas City, Kansas, United States, 66103
Contact: Kelly Lyons, PhD    913-588-7159    klyons@kumc.edu   
United States, Kentucky
University of Louisville Not yet recruiting
Louisville, Kentucky, United States, 40202
Contact: Annette Robinson    502-540-3585    annette.robinson@louisville.edu   
United States, Massachusetts
Tufts Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02111
Contact    617-636-7620      
United States, New York
Weill Cornell Medicine - New York Presbyterian Hospital Not yet recruiting
New York, New York, United States, 10021
Contact: Meem Mahmud    212-746-6581    mem4015@med.cornell.edu   
University of Rochester Medical Center Not yet recruiting
Rochester, New York, United States, 14618
Contact: Sreesravya Betha    585-341-7579    Sreesravya_Betha@URMC.Rochester.edu   
United States, Ohio
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact    216-442-2670    cnrresearchreferrals@ccf.org   
United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Kelly Harper    615-322-2538    Kelly.a.harper@vumc.org   
Canada, Ontario
Toronto Western Hospital Not yet recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Alfonso Fasano, MD, PhD    416-603-6422 ext 5729    alfonso.fasano@uhn.ca   
Sponsors and Collaborators
BlueRock Therapeutics
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Responsible Party: BlueRock Therapeutics
ClinicalTrials.gov Identifier: NCT05363046    
Other Study ID Numbers: BRT-DA01-NIS-001
First Posted: May 5, 2022    Key Record Dates
Last Update Posted: October 6, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases