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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 November 2022 |
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Main ID: |
NCT04154072 |
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Date of registration:
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04/11/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease
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Scientific title:
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Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment With NLY01 in Early-stage Parkinson's Disease |
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Date of first enrolment:
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February 27, 2020 |
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Target sample size:
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255 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04154072 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Dan Lee |
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Address:
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Telephone:
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Email:
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Affiliation:
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Neuraly, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients who are diagnosed with Parkinson's disease according to UK Parkinson's
Disease Society Brain Bank Clinical Diagnostic criteria or Movement Disorder Society
Research Criteria
- Patients with Parkinson's disease according to protocol specified scale assessments
- DaTscan consistent with diagnosis of Parkinson's Disease
- Men or women 30 to 80 years of age
Exclusion Criteria:
- Diagnosis of secondary or atypical parkinsonism
- Prior use of dopaminergic treatment or MAO-B inhibitors for more than 28 days
- Medical or recreational use of marijuana or THC-containing compounds within 3 months
of screening visit
- Pregnant or planning to become pregnant
- Metabolic, surgical, psychiatric or laboratory abnormality that would interfere with
study compliance or safety in the judgment of the investigator
Age minimum:
30 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Intervention(s)
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Drug: NLY01
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Drug: Vehicle
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Primary Outcome(s)
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Change in Unified Parkinson's Disease Rating Scale in combined score of Parts II and III from baseline to 36 weeks
[Time Frame: 36 weeks]
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Secondary ID(s)
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NLY01-PD-1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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