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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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12 December 2020 |
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Main ID: |
NCT03257046 |
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Date of registration:
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14/08/2017 |
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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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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease
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Scientific title:
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A Randomized, Placebo-Controlled, Double-Blind Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ITI-214 in Patients With Idiopathic Parkinson's Disease |
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Date of first enrolment:
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September 28, 2017 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03257046 |
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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 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Kimberly Vanover, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Intra-Cellular Therapies, Inc. |
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Key inclusion & exclusion criteria
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Major Inclusion Criteria:
- Clinical diagnosis of idiopathic Parkinson's disease (PD)
- Severity of PD assessed by Hoehn and Yahr Staging score of 1 to 3
- Maintenance on stable PD therapy
Major Exclusion Criteria:
- Clinical signs of dementia
- Suicidal ideation or behavior
- Considered medically inappropriate for study participation
Age minimum:
50 Years
Age maximum:
N/A
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: ITI-214
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Other: Placebo
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Primary Outcome(s)
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Number of patients with reported or observed treatment-related adverse events
[Time Frame: 7 days]
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Secondary Outcome(s)
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Area of the Curve (AUC)
[Time Frame: 7 days]
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Motor and non-motor symptoms as assessed by the MDS-UPDRS
[Time Frame: 7 days]
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Maximum Plasma Concentration (Cmax)
[Time Frame: 7 days]
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Secondary ID(s)
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ITI-214-105
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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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