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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: |
NCT02871427 |
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Date of registration:
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15/08/2016 |
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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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Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder
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Scientific title:
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An Open-label Study of Nelotanserin in Patients With Lewy Body Dementia Who Have Frequent Visual Hallucinations or REM Sleep Behavior Disorder |
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Date of first enrolment:
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October 20, 2016 |
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Target sample size:
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80 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02871427 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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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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Ilise Lombardo, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Axovant Sciences, Inc., Clinical Research |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects with LBD who completed a previous nelotanserin VH or RBD study
Exclusion Criteria:
- Subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid,
gastrointestinal, renal, hematologic or other medical disorder
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's Disease Dementia
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Dementia With Lewy Bodies
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Lewy Body Dementia
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Visual Hallucinations
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REM Sleep Behavior Disorder
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Intervention(s)
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Drug: Nelotanserin
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Primary Outcome(s)
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Long-term safety and tolerability will be evaluated based on incidence of adverse events (AEs) and significant changes in physical examinations, vital signs, ECGs, and clinical laboratory assessments over time during treatment.
[Time Frame: 24 weeks]
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Long-term effectiveness will be evaluated based on change in the frequency and severity of visual hallucinations (as recorded by patient's caregiver) and/or REM sleep behaviors (based on a clinical evaluator) over time during treatment.
[Time Frame: 24 weeks]
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Secondary ID(s)
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RVT-102-2003
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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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