Trial record 1 of 2 for:
BlueRock Therapeutics | Parkinson Disease
Noninterventional Study Evaluating Parkinson's Disease Diary Use
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| ClinicalTrials.gov Identifier: NCT05363046 |
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Recruitment Status :
Recruiting
First Posted : May 5, 2022
Last Update Posted : October 6, 2022
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Sponsor:
BlueRock Therapeutics
Information provided by (Responsible Party):
BlueRock Therapeutics
- Study Details
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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 |
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.
| 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
MedlinePlus Genetics related topics:
Parkinson disease
MedlinePlus related topics:
Parkinson's Disease
| Group/Cohort |
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Group A
Participants will complete the PD diary on 3 consecutive days in 1 week.
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Group B
Participants will complete the PD diary on 2 consecutive days in each of 2 consecutive weeks.
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Primary Outcome Measures :
- 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.
- 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.
- 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.
Criteria
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
Contacts
| Contact: Marta E Farino-Silva | 1-617-930-9292 | clinicaltrials@bluerocktx.com |
Locations
| 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
| 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 |
| 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 Synucleinopathies Neurodegenerative Diseases |