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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: |
NCT02970019 |
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Date of registration:
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18/11/2016 |
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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 and Tolerability Study of K0706 in Subjects With Parkinson's Disease
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Scientific title:
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A Double-blind, Placebo-controlled Study to Determine Safety, Tolerability, Pharmacokinetic of K0706. |
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Date of first enrolment:
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March 30, 2017 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02970019 |
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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
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Willing and able to give written, and dated, informed consent (or legally acceptable
representative/impartial witness when applicable) and is available for the entire
study
2. Willing and able to comply with the scheduled visits, treatment plan, laboratory
testing, study procedures, and restrictions (in the Investigator's opinion), and be
accessible for follow-up
3. Male or female aged 18 to 65 years (both inclusive)
4. Diagnosed with Parkinson's disease
Exclusion Criteria:
1. Clinical diagnosis of genetic form of Parkinson's disease, or drug-induced
parkinsonism
2. Diagnosis of Parkinson's disease Dementia (probable, possible)
3. Presence of severe dyskinesias
4. History of brain surgery for Parkinson's disease
Age minimum:
18 Years
Age maximum:
65 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: K0706
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Drug: Placebo
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Primary Outcome(s)
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Adverse events
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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Peak plasma concentration
[Time Frame: 4 weeks]
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Time of observed peak plasma concentration
[Time Frame: 4 weeks]
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Area under the plasma concentration versus time curve
[Time Frame: 4 weeks]
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Secondary ID(s)
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CLR_16_27
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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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